Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT02509156
Status:
COMPLETED
Last Update Posted:
2020-11-05
First Post:
2015-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Stem Cell Injection in Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Shelly.L.Sayre@uth.tmc.edu', 'phone': '713-500-9529', 'title': 'Shelly Sayre, M.P.H. Project Manager', 'organization': 'University of Texas-Houston School of Public Health'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Heterogeneous history of cancer; Lengthy time interval (both from cancer diagnosis and AIC diagnosis); Age of cancer records (\\>15 yrs in some cases); Natural history of AIC in our cohort better than expected on the basis of the literature.'}}, 'adverseEventsModule': {'timeFrame': 'Events reported are from randomization date to the 12 month endpoint data collection window (i.e 395 days post intervention)', 'description': 'Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.', 'eventGroups': [{'id': 'EG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 4, 'seriousNumAtRisk': 20, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 4, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Glomerular filtration rate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'seriousEvents': [{'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cardiovascular deconditioning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': "Chrohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Intestinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Sudden cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Drug induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Post operative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Procedural pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Lead dislodgement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Device lead damage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Major Adverse Cardiac Events (MACE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 12 months', 'description': 'Proportion of adjudicated events including death, hospitalization for worsening heart failure, and/or other exacerbation of heart failure (non-hospitalization).', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'Population for safety and feasibility measures include open label lead-in participants (n=6) as well as randomized subjects (n=31).'}, {'type': 'PRIMARY', 'title': 'Proportion of Other Significant Clinical Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 12 months', 'description': 'Proportion of other significant adjudicated clinical events including: non-fatal stroke, non-fatal MI, coronary artery revascularization, ventricular tachycardia/fibrillation, pericardial tamponade, infectious myocarditis, hypersensitivity reaction, neoplasm, and/or other potential deleterious late effects.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'Population for safety and feasibility measures include open label lead-in participants (n=6) as well as randomized subjects (n=31).'}, {'type': 'PRIMARY', 'title': 'Subjects With Events Precluding Their Receipt of Product', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to SPI', 'description': 'Number and percent of subjects with events between randomization and study product injection (SPI) that preclude the subject from receiving product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population for safety and feasibility measures include open label lead-in participants (n=6) as well as randomized subjects (n=31).'}, {'type': 'PRIMARY', 'title': 'Subjects Who Receive Less Than 20 Injections During SPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During SPI procedure', 'description': 'Number and percent of subjects who receive less than 20 injections during SPI', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population for safety and feasibility measures include open label lead-in participants (n=6) as well as randomized subjects who were participating at the time of study product injection (n=30). Note: one placebo patient withdrew after randomization but prior to injection visit.'}, {'type': 'PRIMARY', 'title': 'Subjects Who Did Not Receive the Study Product (Either 100 Million Cells or Placebo)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During SPI procedure', 'description': 'Number and percent of subjects who did not receive the study product (either 100 million cells or placebo)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population for safety and feasibility measures include open label lead-in participants (n=6) as well as randomized subjects who were participating at the time of study product injection (n=30). Note: one placebo patient withdrew after randomization but prior to injection visit.'}, {'type': 'PRIMARY', 'title': 'Subjects Who Have at Least One Cardiac MRI Endpoint Measure That is Uninterpretable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to 12 months', 'description': 'Number and percent of subjects who have at least one cardiac MRI endpoint measure that is uninterpretable due to issues related to the device, including, but not limited to, inability to undergo the procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population for safety and feasibility measures include open label lead-in participants (n=6) as well as randomized subjects (n=31). Analysis population includes only participants who completed an MRI at 12 months (n=32).'}, {'type': 'PRIMARY', 'title': 'Subjects Who Fail to Complete Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to 12 months', 'description': 'Number and percent of subjects who fail to complete follow up', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population for safety and feasibility analysis include open label lead-in participants (n=6)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Left Ventricular Ejection Fraction (LVEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.47', 'spread': '6.00', 'groupId': 'OG000'}, {'value': '2.68', 'spread': '6.85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.746', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '-4.52', 'ciUpperLimit': '6.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.57', 'estimateComment': 'Confidence intervals based on t-test', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in left ventricular ejection fraction as assessed via cardiac MRI.', 'unitOfMeasure': 'percentage of end diastolic volume', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had available analyzable LVEF at baseline and 12 month.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Left Ventricular Ejection Fraction (LVEF)-Trajectory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.81', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '1.33', 'spread': '0.95', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.024', 'groupIds': ['OG000', 'OG001'], 'paramType': 'slope of time', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.53', 'pValueComment': 'No adjustments for multiplicity were made in this Phase I trial', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.63', 'estimateComment': '"Standard error of the mean" is the standard error of the estimate of the slope of time.', 'groupDescription': 'Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.', 'statisticalMethod': 'Repeated Measures Linear Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Assessed as a trajectory (baseline, 6 months, and 12 months)', 'description': 'The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model.', 'unitOfMeasure': 'percentage of end diastolic volume', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had available analyzable LVEF at baseline, 6 month, and 12 month.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Global Strain (HARP MRI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.83', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '2.86', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.328', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.71', 'ciLowerLimit': '-2.68', 'ciUpperLimit': '1.26', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.94', 'estimateComment': 'Confidence intervals based on t-test', 'groupDescription': 'The change in global strain was compared using ANCOVA analyses adjusting for baseline values.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in global circumferential strain as assessed via cardiac MRI', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available analyzable global circumferential strain at baseline and 12 months'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Global Strain (HARP MRI)-Trajectory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.49', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.261', 'groupIds': ['OG000', 'OG001'], 'paramType': 'slope of time', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.26', 'pValueComment': 'No adjustments for multiplicity were made in this Phase I trial.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'estimateComment': '"Standard error of the mean" is the standard error of the estimate over time of the slope', 'groupDescription': 'Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.', 'statisticalMethod': 'Repeated Measures Linear Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Assessed as a trajectory (baseline, 6 months, and 12 months)', 'description': 'The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had available analyzable global strain at baseline, 6 month, and 12 month.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Regional Strain (HARP MRI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.20', 'spread': '3.34', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '3.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.071', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.58', 'ciLowerLimit': '-4.51', 'ciUpperLimit': '1.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.41', 'estimateComment': 'Confidence intervals based on t-test', 'groupDescription': 'The change in regional strain was compared using ANCOVA analyses adjusting for baseline values.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in regional longitudinal strain as assessed via cardiac MRI', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available analyzable regional longitudinal strain at baseline and 12 months'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Regional Strain (HARP MRI)-Trajectory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.58', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '0.52', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.689', 'groupIds': ['OG000', 'OG001'], 'paramType': 'slope of time', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.14', 'pValueComment': 'No adjustments for multiplicity were made in this Phase I trial.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.35', 'estimateComment': '"Standard error of the mean" is the standard error of the estimate over time of the slope', 'groupDescription': 'Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.', 'statisticalMethod': 'Repeated Measures Linear Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Assessed as a trajectory (baseline, 6 months, and 12 months)', 'description': 'The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had available analyzable regional strain at baseline, 6 month, and 12 month.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.30', 'spread': '16.97', 'groupId': 'OG000'}, {'value': '-3.36', 'spread': '15.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.935', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '-12.33', 'ciUpperLimit': '14.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.46', 'estimateComment': 'Confidence intervals based on t-test', 'groupDescription': 'The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in left ventricular end diastolic volume index as measured via cardiac MRI', 'unitOfMeasure': 'ratio- unitless', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available analyzable LVEDVI at baseline and 12 months'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVI)-Trajectory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.94', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '-1.98', 'spread': '1.95', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.325', 'groupIds': ['OG000', 'OG001'], 'paramType': 'slope of time', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.56', 'pValueComment': 'No adjustments for multiplicity were made in this Phase I trial.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.55', 'estimateComment': '"Standard error of the mean" is the standard error of the estimate over time of the slope', 'groupDescription': 'Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.', 'statisticalMethod': 'Repeated Measures Linear Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Assessed as a trajectory (baseline, 6 months, and 12 months)', 'description': 'The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model.', 'unitOfMeasure': 'ratio-unitless', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had available analyzable LVEDVI at baseline, 6 month, and 12 month.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Left Ventricular End Systolic Volume Index (LVESVI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.62', 'spread': '15.66', 'groupId': 'OG000'}, {'value': '-4.28', 'spread': '14.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.919', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '-11.75', 'ciUpperLimit': '13.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.99', 'estimateComment': 'Confidence intervals based on t-test', 'groupDescription': 'The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in left ventricular end systolic volume index as assessed via cardiac MRI', 'unitOfMeasure': 'ratio- unitless', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available analyzable LVESVI at baseline and 12 months'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Left Ventricular End Systolic Volume Index (LVESVI)-Trajectory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.05', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '-2.34', 'spread': '1.81', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.183', 'groupIds': ['OG000', 'OG001'], 'paramType': 'slope of time', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.99', 'pValueComment': 'No adjustments for multiplicity were made in this Phase I trial.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.45', 'estimateComment': '"Standard error of the mean" is the standard error of the estimate over time of the slope.', 'groupDescription': 'Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.', 'statisticalMethod': 'Repeated Measures Linear Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Assessed as a trajectory (baseline, 6 months, and 12 months)', 'description': 'The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model.', 'unitOfMeasure': 'ratio- unitless', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had available analyzable LVESVI at baseline, 6 month, and 12 month.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Left Ventricular Sphericity Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.124', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.077', 'ciLowerLimit': '0.003', 'ciUpperLimit': '0.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.035', 'estimateComment': 'Confidence intervals based on t-test', 'groupDescription': 'The change in LV sphericity index was compared using ANCOVA analyses adjusting for baseline values.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in Left Ventricular Sphericity Index as assessed by cardiac MRI. Sphericity index is the ratio of the long and short axis measurements of the left ventricle.', 'unitOfMeasure': 'ratio- unitless', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had available analyzable LV sphericity index at baseline and 12 month LV.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Left Ventricular Sphericity Index-Trajectory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.005', 'spread': '0.013', 'groupId': 'OG000'}, {'value': '-0.037', 'spread': '0.012', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. A time by treatment interaction was assessed.', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'There was a significant treatment and time interaction (p=0.024), so we report a slope for each treatment arm.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Assessed as a trajectory (baseline, 6 months, and 12 months)', 'description': 'The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model.\n\nSphericity index is the ratio of the long and short axis measurements of the left ventricle.', 'unitOfMeasure': 'ratio-unitless', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had available analyzable sphericity index at baseline, 6 month, and 12 month.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Area of Injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.06', 'spread': '2.44', 'groupId': 'OG000'}, {'value': '-0.41', 'spread': '2.76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.993', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.66', 'ciLowerLimit': '-3.05', 'ciUpperLimit': '1.74', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.14', 'estimateComment': 'Confidence intervals based on t-test', 'groupDescription': 'The change in scar percent was compared using ANCOVA analyses adjusting for baseline values.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in the scar percent (scar mass normalized to left ventricular mass) as assessed via cardiac MRI.', 'unitOfMeasure': 'percentage of mass', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had available analyzable scar percent at baseline and 12 month.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Area of Injury-Trajectory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.56', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '0.43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.151', 'groupIds': ['OG000', 'OG001'], 'paramType': 'slope of time', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.44', 'pValueComment': 'No adjustments for multiplicity were made in this Phase I trial.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.29', 'estimateComment': '"Standard error of the mean" is the standard error of the estimate over time of the slope', 'groupDescription': 'Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.', 'statisticalMethod': 'Repeated Measures Linear Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Assessed as a trajectory (baseline, 6 months, and 12 months)', 'description': 'The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model.', 'unitOfMeasure': 'percentage of mass', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had available analyzable scar percent at baseline, 6 month, and 12 month.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Exercise Tolerance (Six Minute Walk Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}], 'classes': [{'categories': [{'measurements': [{'value': '34.96', 'spread': '61.62', 'groupId': 'OG000'}, {'value': '-3.07', 'spread': '42.90', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.056', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '38.03', 'ciLowerLimit': '-5.84', 'ciUpperLimit': '81.89', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '20.96', 'estimateComment': 'Confidence intervals based on t-test', 'groupDescription': 'The change in distance walked was compared using ANCOVA analyses adjusting for baseline values.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in the distance walked (in meters) as measured by the six minute walk test. Two walk tests were completed at each endpoint visit (separated by 30 min). The average distance of the two walk tests will be used for analysis.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had available analyzable walk tests at baseline and 12 month.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Exercise Tolerance (Six Minute Walk Test)-Trajectory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}], 'classes': [{'categories': [{'measurements': [{'value': '9.81', 'spread': '7.53', 'groupId': 'OG000'}, {'value': '-3.43', 'spread': '5.72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.583', 'groupIds': ['OG000', 'OG001'], 'paramType': 'slope of time', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.82', 'pValueComment': 'No adjustments for multiplicity were made in this Phase I trial.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.06', 'estimateComment': '"Standard error of the mean" is the standard error of the estimate over time of the slope', 'groupDescription': 'Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.', 'statisticalMethod': 'Repeated Measures Linear Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Assessed as a trajectory (baseline, 6 months, and 12 months)', 'description': 'Change in the distance walked (in feet) as measured by the six minute walk test. Two walk tests were completed at each endpoint visit (separated by 30 min). The average distance of the two walk tests will be used for analysis. The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had available analyzable six minute walk test data at baseline, 6 month, and 12 month.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}], 'classes': [{'categories': [{'measurements': [{'value': '-25.45', 'spread': '25.65', 'groupId': 'OG000'}, {'value': '-12.63', 'spread': '14.59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.048', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.82', 'ciLowerLimit': '-30.49', 'ciUpperLimit': '4.84', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.37', 'estimateComment': 'Confidence intervals based on t-test', 'groupDescription': 'The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in the quality of life summary score as measured by the Minnesota Living with Heart Failure Questionnaire. Minimum and maximum scores for scale are 0 and 105 respectively. Lower scores indicative of better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had available analyzable MLHFQ summary score at baseline and 12 month.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score-Trajectory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.15', 'spread': '2.94', 'groupId': 'OG000'}, {'value': '-6.05', 'spread': '1.92', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'slope of time', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-8.07', 'pValueComment': 'No adjustments for multiplicity were made in this Phase I trial.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.86', 'estimateComment': '"Standard error of the mean" is the standard error of the estimate over time of the slope.', 'groupDescription': 'Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.', 'statisticalMethod': 'Repeated Measures Linear Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Assessed as a trajectory (baseline, 6 months, and 12 months)', 'description': 'The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model.\n\nMinimum and maximum scores for scale are 0 and 105 respectively. Lower scores indicative of better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had available analyzable MLHFQ data at baseline, 6 month, and 12 month.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}], 'classes': [{'categories': [{'measurements': [{'value': '-392.58', 'spread': '953.71', 'groupId': 'OG000'}, {'value': '-76.76', 'spread': '410.48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.199', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-315.80', 'ciLowerLimit': '-947.50', 'ciUpperLimit': '315.80', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '295', 'estimateComment': 'Confidence intervals based on t-test', 'groupDescription': 'The change in NT-proBNP was compared using ANCOVA analyses adjusting for baseline values. Data log transformed. p-values were obtained from transformed data.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in N-Terminal pro-Brain Natriuretic Peptide (NT-proBNP) as measured via laboratory blood draw', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had available analyzable NT-proBNP results at baseline and 12 month. Log transformation used. p-values were obtained from transformed data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)-Trajectory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}], 'classes': [{'categories': [{'measurements': [{'value': '-184.18', 'spread': '113.16', 'groupId': 'OG000'}, {'value': '-58.58', 'spread': '49.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.229', 'groupIds': ['OG000', 'OG001'], 'paramType': 'slope of time', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-23.391', 'pValueComment': 'No adjustments for multiplicity were made in this Phase I trial.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '202.080', 'estimateComment': '"Standard error of the mean" is the standard error of the estimate over time of the slope', 'groupDescription': 'Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported. Log transformation used for the regression. p-values were obtained from transformed data.', 'statisticalMethod': 'Repeated Measures Linear Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Assessed as a trajectory (baseline, 6 months, and 12 months)', 'description': 'The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had available analyzable NT-proBNP results at baseline, 6 month, and 12 month. Log transformation used for the regression. p-values were obtained from transformed data.'}, {'type': 'SECONDARY', 'title': 'Cumulative Days Alive and Out of Hospital for Heart Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}], 'classes': [{'categories': [{'measurements': [{'value': '368', 'spread': '25.8', 'groupId': 'OG000'}, {'value': '363', 'spread': '31.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to End of 12 Month Visit Window (i.e. 395 days after intervention)', 'description': 'Days alive and out of hospital for heart failure during the study evaluation period. Subjects were allotted a visit window extending 30 days past their anticipated 12-month visit (i.e., 395 days).', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Comparison of the two groups on days alive and out of the hospital for heart failure during the 12 month study evaluation period. Analysis includes all study subjects (including the 6 open label patients).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}], 'periods': [{'title': 'Open-Label Lead-In Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Randomized Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Includes randomized participants only', 'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Enrollment took place at seven CCTRN centers between September 2016 and October 2018. The main centers are located in Texas, Florida (2 locations), Minnesota, Kentucky, Indiana, and California. Recruitment methods included www.clinicaltrials.gov, cancer survivorship organization websites, and local cancer center physician outreach.', 'preAssignmentDetails': '46 subjects consented to participate; 37 completed baseline testing and met eligibility criteria. This includes 6 (open label) and 31 (randomized) subjects. Reasons for failed eligibility (n=9) include elevated LVEF, failure to complete baseline testing, MRI contraindications, and investigator discretion.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs\n\nAllo-MSCs: 20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Buminate solution\n\nPlacebo: 20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54.7', 'spread': '12.8', 'groupId': 'BG000'}, {'value': '58.2', 'spread': '11.2', 'groupId': 'BG001'}, {'value': '56.6', 'spread': '11.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30.2', 'spread': '9', 'groupId': 'BG000'}, {'value': '30.4', 'spread': '6.5', 'groupId': 'BG001'}, {'value': '30.3', 'spread': '7.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Heart rate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '74.4', 'spread': '9', 'groupId': 'BG000'}, {'value': '76.1', 'spread': '11.2', 'groupId': 'BG001'}, {'value': '75.4', 'spread': '10.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic blood pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '118.6', 'spread': '21.6', 'groupId': 'BG000'}, {'value': '115.4', 'spread': '11.0', 'groupId': 'BG001'}, {'value': '116.8', 'spread': '16.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic blood pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '68.9', 'spread': '18.6', 'groupId': 'BG000'}, {'value': '67.1', 'spread': '11.2', 'groupId': 'BG001'}, {'value': '67.9', 'spread': '14.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diabetes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertension', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking (lifetime)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Left ventricular ejection fraction', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '33.7', 'spread': '3.4', 'groupId': 'BG000'}, {'value': '32.5', 'spread': '6.5', 'groupId': 'BG001'}, {'value': '33.0', 'spread': '5.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of blood ejected', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Previous hospitalization for heart failure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous emergency department visit for heart failure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Time since AIC diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.1', 'spread': '5.9', 'groupId': 'BG000'}, {'value': '8.7', 'spread': '5.0', 'groupId': 'BG001'}, {'value': '7.5', 'spread': '5.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Time since anthracycline induced cardiomyopathy diagnosis (years)', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'New York Heart Association class II', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Physicians use the NYHA classification system to place patients in one of four categories based on how much they are limited during physical activity. Class II is characterized by slight limitation of physical activity. The patient is comfortable at rest, however ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).', 'unitOfMeasure': 'Participants'}, {'title': 'New York Heart Association class III', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Physicians use the NYHA classification system to place patients in one of four categories based on how much they are limited during physical activity. Class III is characterized by marked limitation of physical activity. The patient is comfortable at rest. Less than ordinary activity however, causes fatigue, palpitation, or dyspnea.', 'unitOfMeasure': 'Participants'}, {'title': 'Presence of a cardiac device', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Presence of a cardiac device (implantable cardioverter defibrillator or pacemaker)', 'unitOfMeasure': 'Participants'}, {'title': 'Angina', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sustained ventricular arrhythmia', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Leukemia', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Breast cancer', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': "Hodgkin's disease", 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': "Non-Hodgkin's lymphoma", 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sarcomas', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Multiple cancers', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Doxorubicin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Epirubicin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Daunorubicin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'AIC exposure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '353.0', 'spread': '351.3', 'groupId': 'BG000'}, {'value': '339.5', 'spread': '113.6', 'groupId': 'BG001'}, {'value': '346.2', 'spread': '254.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Limited information due to treatment record availability (\\>15yrs). Dosing information (mg/m\\^2) not always available. Data represents a subset of the cohort.'}, {'title': 'Time from Cancer Diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '16.4', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '18.8', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '17.7', 'spread': '8.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Time from earliest diagnosis requiring anthracycline treatment', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time from last anthracycline treatment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13.3', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '16.8', 'spread': '7.6', 'groupId': 'BG001'}, {'value': '15.2', 'spread': '8.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-13', 'size': 647412, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-06-24T11:51', 'hasProtocol': False}, {'date': '2018-10-19', 'size': 8640430, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-06-16T14:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-13', 'studyFirstSubmitDate': '2015-07-23', 'resultsFirstSubmitDate': '2020-09-15', 'studyFirstSubmitQcDate': '2015-07-23', 'lastUpdatePostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-13', 'studyFirstPostDateStruct': {'date': '2015-07-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Major Adverse Cardiac Events (MACE)', 'timeFrame': 'Baseline to 12 months', 'description': 'Proportion of adjudicated events including death, hospitalization for worsening heart failure, and/or other exacerbation of heart failure (non-hospitalization).'}, {'measure': 'Proportion of Other Significant Clinical Events', 'timeFrame': 'Baseline to 12 months', 'description': 'Proportion of other significant adjudicated clinical events including: non-fatal stroke, non-fatal MI, coronary artery revascularization, ventricular tachycardia/fibrillation, pericardial tamponade, infectious myocarditis, hypersensitivity reaction, neoplasm, and/or other potential deleterious late effects.'}, {'measure': 'Subjects With Events Precluding Their Receipt of Product', 'timeFrame': 'Randomization to SPI', 'description': 'Number and percent of subjects with events between randomization and study product injection (SPI) that preclude the subject from receiving product.'}, {'measure': 'Subjects Who Receive Less Than 20 Injections During SPI', 'timeFrame': 'During SPI procedure', 'description': 'Number and percent of subjects who receive less than 20 injections during SPI'}, {'measure': 'Subjects Who Did Not Receive the Study Product (Either 100 Million Cells or Placebo)', 'timeFrame': 'During SPI procedure', 'description': 'Number and percent of subjects who did not receive the study product (either 100 million cells or placebo)'}, {'measure': 'Subjects Who Have at Least One Cardiac MRI Endpoint Measure That is Uninterpretable', 'timeFrame': 'Baseline to 12 months', 'description': 'Number and percent of subjects who have at least one cardiac MRI endpoint measure that is uninterpretable due to issues related to the device, including, but not limited to, inability to undergo the procedure.'}, {'measure': 'Subjects Who Fail to Complete Follow-up', 'timeFrame': 'Baseline to 12 months', 'description': 'Number and percent of subjects who fail to complete follow up'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in left ventricular ejection fraction as assessed via cardiac MRI.'}, {'measure': 'Change From Baseline in Left Ventricular Ejection Fraction (LVEF)-Trajectory', 'timeFrame': 'Assessed as a trajectory (baseline, 6 months, and 12 months)', 'description': 'The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model.'}, {'measure': 'Change From Baseline in Global Strain (HARP MRI)', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in global circumferential strain as assessed via cardiac MRI'}, {'measure': 'Change From Baseline in Global Strain (HARP MRI)-Trajectory', 'timeFrame': 'Assessed as a trajectory (baseline, 6 months, and 12 months)', 'description': 'The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model.'}, {'measure': 'Change From Baseline in Regional Strain (HARP MRI)', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in regional longitudinal strain as assessed via cardiac MRI'}, {'measure': 'Change From Baseline in Regional Strain (HARP MRI)-Trajectory', 'timeFrame': 'Assessed as a trajectory (baseline, 6 months, and 12 months)', 'description': 'The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model.'}, {'measure': 'Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVI)', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in left ventricular end diastolic volume index as measured via cardiac MRI'}, {'measure': 'Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVI)-Trajectory', 'timeFrame': 'Assessed as a trajectory (baseline, 6 months, and 12 months)', 'description': 'The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model.'}, {'measure': 'Change From Baseline in Left Ventricular End Systolic Volume Index (LVESVI)', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in left ventricular end systolic volume index as assessed via cardiac MRI'}, {'measure': 'Change From Baseline in Left Ventricular End Systolic Volume Index (LVESVI)-Trajectory', 'timeFrame': 'Assessed as a trajectory (baseline, 6 months, and 12 months)', 'description': 'The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model.'}, {'measure': 'Change From Baseline in Left Ventricular Sphericity Index', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in Left Ventricular Sphericity Index as assessed by cardiac MRI. Sphericity index is the ratio of the long and short axis measurements of the left ventricle.'}, {'measure': 'Change From Baseline in Left Ventricular Sphericity Index-Trajectory', 'timeFrame': 'Assessed as a trajectory (baseline, 6 months, and 12 months)', 'description': 'The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model.\n\nSphericity index is the ratio of the long and short axis measurements of the left ventricle.'}, {'measure': 'Change From Baseline in Area of Injury', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in the scar percent (scar mass normalized to left ventricular mass) as assessed via cardiac MRI.'}, {'measure': 'Change From Baseline in Area of Injury-Trajectory', 'timeFrame': 'Assessed as a trajectory (baseline, 6 months, and 12 months)', 'description': 'The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model.'}, {'measure': 'Change From Baseline in Exercise Tolerance (Six Minute Walk Test)', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in the distance walked (in meters) as measured by the six minute walk test. Two walk tests were completed at each endpoint visit (separated by 30 min). The average distance of the two walk tests will be used for analysis.'}, {'measure': 'Change From Baseline in Exercise Tolerance (Six Minute Walk Test)-Trajectory', 'timeFrame': 'Assessed as a trajectory (baseline, 6 months, and 12 months)', 'description': 'Change in the distance walked (in feet) as measured by the six minute walk test. Two walk tests were completed at each endpoint visit (separated by 30 min). The average distance of the two walk tests will be used for analysis. The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model.'}, {'measure': 'Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in the quality of life summary score as measured by the Minnesota Living with Heart Failure Questionnaire. Minimum and maximum scores for scale are 0 and 105 respectively. Lower scores indicative of better outcome.'}, {'measure': 'Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score-Trajectory', 'timeFrame': 'Assessed as a trajectory (baseline, 6 months, and 12 months)', 'description': 'The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model.\n\nMinimum and maximum scores for scale are 0 and 105 respectively. Lower scores indicative of better outcome.'}, {'measure': 'Change From Baseline in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in N-Terminal pro-Brain Natriuretic Peptide (NT-proBNP) as measured via laboratory blood draw'}, {'measure': 'Change From Baseline in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)-Trajectory', 'timeFrame': 'Assessed as a trajectory (baseline, 6 months, and 12 months)', 'description': 'The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). If there is no interaction between change over time and treatment a single calculated value is the slope (the change per six months) from the model. If there is an interaction, the p-value for interaction is presented along with two calculated values representing the slope (the change per six months) for each treatment arm from the model.'}, {'measure': 'Cumulative Days Alive and Out of Hospital for Heart Failure', 'timeFrame': 'Baseline to End of 12 Month Visit Window (i.e. 395 days after intervention)', 'description': 'Days alive and out of hospital for heart failure during the study evaluation period. Subjects were allotted a visit window extending 30 days past their anticipated 12-month visit (i.e., 395 days).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cardiomyopathy', 'AIC', 'Anthracyclines', 'Chemotherapy', 'Allogeneic', 'Mesenchymal stem cells', 'MSCs', 'Cancer survivors', 'Breast Cancer', 'Leukemia', 'Lymphoma', 'Sarcoma'], 'conditions': ['Cardiomyopathy Due to Anthracyclines']}, 'referencesModule': {'references': [{'pmid': '20850099', 'type': 'BACKGROUND', 'citation': 'Psaltis PJ, Carbone A, Nelson AJ, Lau DH, Jantzen T, Manavis J, Williams K, Itescu S, Sanders P, Gronthos S, Zannettino AC, Worthley SG. Reparative effects of allogeneic mesenchymal precursor cells delivered transendocardially in experimental nonischemic cardiomyopathy. JACC Cardiovasc Interv. 2010 Sep;3(9):974-83. doi: 10.1016/j.jcin.2010.05.016.'}, {'pmid': '19121814', 'type': 'BACKGROUND', 'citation': 'Nazarian S, Halperin HR. How to perform magnetic resonance imaging on patients with implantable cardiac arrhythmia devices. Heart Rhythm. 2009 Jan;6(1):138-43. doi: 10.1016/j.hrthm.2008.10.021. Epub 2008 Oct 22. No abstract available.'}, {'pmid': '29910056', 'type': 'BACKGROUND', 'citation': 'Bolli R, Hare JM, Henry TD, Lenneman CG, March KL, Miller K, Pepine CJ, Perin EC, Traverse JH, Willerson JT, Yang PC, Gee AP, Lima JA, Moye L, Vojvodic RW, Sayre SL, Bettencourt J, Cohen M, Ebert RF, Simari RD; Cardiovascular Cell Therapy Research Network (CCTRN). Rationale and Design of the SENECA (StEm cell iNjECtion in cAncer survivors) Trial. Am Heart J. 2018 Jul;201:54-62. doi: 10.1016/j.ahj.2018.02.009. Epub 2018 Apr 4.'}], 'seeAlsoLinks': [{'url': 'http://www.cctrn.org', 'label': 'Cardiovascular Cell Therapy Research Network'}, {'url': 'http://www.nhlbi.nih.gov', 'label': 'National Heart, Lung, and Blood Institute'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to examine the safety and feasibility of delivering allogeneic human mesenchymal stem cells (allo-MSCs) by transendocardial injection to cancer survivors with left ventricular (LV) dysfunction secondary to anthracycline-induced cardiomyopathy (AIC).\n\nThe secondary purpose of this study is to obtain preliminary evidence for therapeutic efficacy of allo-MSCs delivered by transendocardial injection to cancer survivors with LV dysfunction secondary to AIC.', 'detailedDescription': 'This phase I, randomized, placebo-controlled, trial will evaluate the safety and feasibility of allo-MSCs administered by transendocardial injection in thirty-seven subjects with anthracycline-induced cardiomyopathy (AIC). The first six subjects received allo-MSC therapy (open label) and were assessed for safety and feasibility of the study procedures. Following 1 month data review of each of the six subjects by the National Heart, Lung, and Blood Institute Gene and Cell Therapy Data Safety Monitoring Board; this was followed by a randomized, double-blind clinical trial enrolling thirty-one subjects. These subjects were randomized 1:1 to receive allo-MSCs or placebo. All subjects underwent cardiac catheterization and study product administration using the NOGA Myostar catheter injection system. Subjects are being followed at 1 day, 1 week, 1 month, 6 months, and 12 months post study product injection. All endpoints are assessed at the 6 and 12 month visits which will occur 180 ±30 days and 365 ±30 days, respectively, after the day of study product injection (Day 0). For the purpose of the safety evaluations and endpoint analysis, the Investigators will utilize an "intention-to-treat" study population. In addition, because this phase I study is the first cell therapy study in this population, at 12 months available standard-of-care medical records for cancer surveillance will be reviewed for cancer recurrence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nTo participate, a subject MUST:\n\n1. Be ≥ 18 and \\< 80 years of age\n2. Be a cancer survivor with diagnosis of AIC\n3. Have an LVEF ≤ 45% by cMRI\n4. Be in NYHA class II-III\n5. Have received the initial diagnosis of AIC at least six months earlier and be on stable, optimally-tolerated therapy with beta-blockers, ACE inhibitors/ARBs, and/or aldosterone antagonists for 3 months, unless contraindicated\n6. Have a period of at least two years of clinical cancer-free state\\* and low likelihood of recurrence (a five-year risk of recurrence estimated at 30% or less), as determined by an oncologist, based on tumor type, response to therapy, and negative metastatic work-up at the time of diagnosis (\\*exceptions to this are carcinoma in situ or fully resected basal and squamous cell cancer of the skin.)\n7. Be a candidate for cardiac catheterization\n\nExclusion Criteria\n\nTo participate, a subject MUST NOT HAVE:\n\n1. A life expectancy \\<12 months\n2. A CT scan or baseline cardiac MRI showing new tumor or suspicious lymphadenopathy raising concern of malignancy\n3. Presence of obstructive CAD as determined via imaging within 5 years prior to study enrollment provided there have been no symptoms or evidence of CAD since the test\n4. Had a previous myocardial infarction\n5. A history of radiation therapy AND evidence of constrictive physiology and/or evidence of other patterns of non-ischemic cardiomyopathy on cardiac MRI (e.g., amyloidosis, sarcoidosis, hemochromatosis, pure radiation-induced cardiomyopathy, etc.) not consistent with AIC being the dominant etiology of heart failure\n6. Valvular heart disease including 1) mechanical or bioprosthetic heart valve; or 2) severe valvular (any valve) insufficiency/regurgitation within 12 months of consent.\n7. Aortic stenosis with valve area ≤ 1.5cm2\n8. A history of LV reduction surgery or cardiomyoplasty\n9. Evidence of cardiogenic shock\n10. A history of ischemic or hemorrhagic stroke within 90 days of baseline testing\n11. Liver dysfunction during baseline testing, as evidenced by enzymes (e.g., AST, ALT, alkaline phosphatase) greater than 3 times upper limit of normal\n12. Diabetes with poorly controlled blood glucose levels (HbA1c \\> 8.5%)\n13. An underlying autoimmune disorder or current immunosuppressive therapy (e.g., chronic corticosteroid, rheumatologic or immune modulating therapy) or likelihood of use of immunosuppressive therapy during participation in the trial (medications will be considered on a case by case basis)\n14. A baseline eGFR \\<35 ml/min/1.73m2\n15. A contrast allergy that cannot adequately be managed by premedication\n16. Received gene or cell-based therapy from any source within the previous 12 months\n17. A hematologic abnormality during baseline testing as evidenced by hemoglobin \\< 9 g/dl; hematocrit \\< 30%; absolute neutrophil count \\< 2,000 or total WBC count more than 2 times upper limit of normal; or platelet values \\< 100,000/ul\n18. Evidence of active systemic infection at time of study product delivery\n19. HIV and/or active HBV or HCV\n20. Coagulopathy (INR \\> 1.5) not due to a reversible cause (e.g., warfarin and/or Factor Xa inhibitors) (see Section 6.4 re: injection procedure and anticoagulation therapy) Note: Subjects who cannot be withdrawn from anticoagulation will be excluded.\n21. Presence of LV thrombus\n22. Presence of a pacemaker and/or ICD generator with any of the following limitations/conditions:\n\n * manufactured before the year 2000\n * leads implanted \\< 6 weeks prior to consent\n * non-transvenous epicardial or abandoned leads\n * subcutaneous ICDs\n * leadless pacemakers\n * any other condition that, in the judgment of device-trained staff, would deem an MRI contraindicated\n23. Pacemaker-dependence with an ICD (Note: pacemaker-dependent candidates without an ICD are not excluded)\n24. A cardiac resynchronization therapy (CRT) device implanted \\< 3 months prior to consent\n25. Other MRI contraindications (e.g. patient body habitus incompatible with MRI)\n26. An appropriate ICD firing or anti-tachycardia pacing (ATP) for ventricular fibrillation or ventricular tachycardia within 30 days of consent\n27. Ventricular tachycardia ≥ 20 consecutive beats without an ICD within 3 months of consent, or symptomatic Mobitz II or higher degree atrioventricular block without a functioning pacemaker within 3 months of consent\n28. A history of drug abuse (use of illegal "street" drugs except marijuana, or prescription medications not being used appropriately for a pre-existing medical condition) or alcohol abuse (≥ 5 drinks/day for ˃ 3 months), or documented medical, occupational, or legal problems arising from the use of alcohol or drugs within the past 24 months\n29. Cognitive or language barriers that prohibit obtaining informed consent or any study elements (interpreter permitted)\n30. Participation (currently or within the previous 30 days) in a cardiac related investigational therapeutic (including stem cell based therapies) or device trial\n31. Pregnancy, lactation, plans to become pregnant in the next 12 months, or is unwilling to use acceptable forms of birth control during study participation\n32. Any other condition that, in the judgment of the Investigator or Sponsor, would be a contraindication to enrollment, study product administration, or follow-up'}, 'identificationModule': {'nctId': 'NCT02509156', 'acronym': 'SENECA', 'briefTitle': 'Stem Cell Injection in Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'A Phase I, First-in-Human, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of the Safety and Efficacy of Allogeneic Mesenchymal Stem Cells in Cancer Survivors With Anthracycline-Induced Cardiomyopathy', 'orgStudyIdInfo': {'id': 'HSC-SPH-15-0443'}, 'secondaryIdInfos': [{'id': '5UM1HL087318', 'link': 'https://reporter.nih.gov/quickSearch/5UM1HL087318', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Allo-MSCs', 'description': 'Target dose of 100 million allo-MSCs', 'interventionNames': ['Biological: Allo-MSCs']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Buminate solution', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Allo-MSCs', 'type': 'BIOLOGICAL', 'otherNames': ['Allogeneic Mesenchymal Stem Cells'], 'description': '20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)', 'armGroupLabels': ['Allo-MSCs']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'otherNames': ['Buminate solution'], 'description': '20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida-Department of Medicine', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33101', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami-Interdiciplinary Stem Cell Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Center for Vascular Biology and Medicine', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis Heart Institute Foundation', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Heart Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Robert Simari, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'CCTRN Steering Committee Chair'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Biostatistics', 'investigatorFullName': 'Barry R Davis', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}