Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-27 @ 5:01 AM
Study NCT ID:
NCT04614467
Status:
TERMINATED
Last Update Posted:
2023-10-17
First Post:
2020-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Placebo-Controlled Trial of CLBS16 in Subjects With Coronary Microvascular Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-09-10', 'mcpReleaseN': 21, 'releaseDate': '2025-08-25'}], 'estimatedResultsFirstSubmitDate': '2025-08-25'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D017566', 'term': 'Microvascular Angina'}, {'id': 'D000787', 'term': 'Angina Pectoris'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'whyStopped': 'Sponsor decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'dispFirstSubmitDate': '2023-10-02', 'completionDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-09', 'studyFirstSubmitDate': '2020-10-29', 'studyFirstSubmitQcDate': '2020-10-29', 'dispFirstPostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in angina frequency', 'timeFrame': 'Baseline to 3 and 6 months'}, {'measure': 'Change from baseline in CCS angina class', 'timeFrame': 'Baseline to 3 and 6 months'}, {'measure': 'Change from baseline in total exercise time', 'timeFrame': 'Baseline to 6 months'}, {'measure': 'Change from baseline in health-related quality of life (HRQoL)', 'timeFrame': 'Baseline to 3 and 6 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['angina', 'CMD', 'MVD', 'non-obstructive coronary artery disease'], 'conditions': ['Coronary Microvascular Dysfunction', 'Coronary Microvascular Disease', 'Microvascular Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '34066713', 'type': 'DERIVED', 'citation': 'Rai B, Shukla J, Henry TD, Quesada O. Angiogenic CD34 Stem Cell Therapy in Coronary Microvascular Repair-A Systematic Review. Cells. 2021 May 8;10(5):1137. doi: 10.3390/cells10051137.'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial will explore the efficacy and safety of GCSF-mobilized autologous CD34+ cells for the treatment of CMD in adults currently experiencing angina and with no obstructive coronary artery disease. Eligible subjects will receive a single administration of CLBS16 or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women age ≥18\n* History of and currently experiencing angina at least 3 times per week\n* Prior diagnosis of CMD based on coronary flow reserve (CFR) ≤ 2.5 or other measures\n* Canadian Cardiovascular Society (CCS) class II, III or IV chronic refractory angina\n* No obstructive coronary artery disease\n* On stable medical therapy for at least 30 days prior to enrollment\n* Must agree to use a reliable and acceptable method of contraception for the duration of participation\n* Written informed consent\n\nExclusion Criteria:\n\n* Myocardial infarction within 90 days\n* Prior evidence of obstructive heart disease including PCI or CABG (or planned PCI or CABG)\n* Diagnosis of other specific cardiac disease\n* Must meet LVEF and GFR requirements\n* Current use of coumadin or DOACs\n* Hypersensitivity to GCSF, apheresis or study product components\n* Positive for HIV, hepatitis B or hepatitis C\n* Active inflammatory or autoimmune disease, or chronic immunosuppressive state\n* Drug abuse\n* Pregnant or lactating\n* Malignant neoplasm within 5 years\n* History of Sickle Cell Disease\n* Participation in another clinical study within 90 days prior to informed consent or concurrently with this study\n* Previous treatment with a CD34+ cell based therapy'}, 'identificationModule': {'nctId': 'NCT04614467', 'acronym': 'FREEDOM', 'briefTitle': 'A Placebo-Controlled Trial of CLBS16 in Subjects With Coronary Microvascular Dysfunction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lisata Therapeutics, Inc.'}, 'officialTitle': 'A Double-Blind, Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of CLBS16 in Subjects With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'CLBS16-P02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GCSF-mobilized autologous CD34+ cells', 'interventionNames': ['Biological: CLBS16']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'CLBS16', 'type': 'BIOLOGICAL', 'description': 'GCSF-mobilized autologous CD34+ cells', 'armGroupLabels': ['GCSF-mobilized autologous CD34+ cells']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'isotonic solution (no CD34+ cells)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '32606', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida - College of Medicine/ div of Cardiovascular Medicine', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Memorial Regional Hospital', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis Heart Institute at Abbott Northwestern Hospital', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Christ Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Kristen K Buck, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lisata Therapeutics, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lisata Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}