Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-24 @ 8:23 PM
Study NCT ID:
NCT02032004
Status:
COMPLETED
Last Update Posted:
2022-01-10
First Post:
2014-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria', 'Belarus', 'Bulgaria', 'Finland', 'France', 'Germany', 'Italy', 'Latvia', 'Lithuania', 'Netherlands', 'Poland', 'Russia', 'Singapore', 'Slovenia', 'Spain', 'Sweden', 'Switzerland', 'United Kingdom'], 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-10-16', 'releaseDate': '2025-10-02'}], 'estimatedResultsFirstSubmitDate': '2025-10-02'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}], 'ancestors': [{'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 566}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'dispFirstSubmitDate': '2021-05-21', 'completionDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-05', 'studyFirstSubmitDate': '2014-01-08', 'dispFirstSubmitQcDate': '2021-05-21', 'studyFirstSubmitQcDate': '2014-01-08', 'dispFirstPostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pharmacodynamics Measures (N-terminal (NT)-pro hormone BNP [NT-proBNP] and high-sensitivity C-reactive protein [hs-CRP])', 'timeFrame': 'Screening, months 3, 6, 12 and every 12 months thereafter until study conclusion'}, {'measure': 'Pharmacogenomics (PGx) Analysis', 'timeFrame': 'Screening (only from those subjects who provide consent to participate in PGx sample collection)'}, {'measure': 'Immunogenicity Measures (panel reactive antibodies, donor specific antibody, if panel-reactive antibody (PRA) test is positive, antibodies against bovine and murine products)', 'timeFrame': 'Screening, day 10, months 1, 3, 6, and 12'}], 'primaryOutcomes': [{'measure': 'Time to recurrent non-fatal decompensated heart failure major adverse cardiac events (HF-MACE) that occur prior to the first terminal cardiac event (TCE).', 'timeFrame': '6 Month minimum'}], 'secondaryOutcomes': [{'measure': 'Time-to-first terminal cardiac event (TCE)', 'timeFrame': '6 Month minimum'}, {'measure': 'Time-to-hospital admissions for non-fatal decompensated HF events', 'timeFrame': '6 Month minimum'}, {'measure': 'Time-to-urgent care outpatient HF visits', 'timeFrame': '6 Month minimum'}, {'measure': 'Time-to-successfully resuscitated cardiac death (RCD) events', 'timeFrame': '6 Month minimum'}, {'measure': 'Total length of in-hospital stay in intensive care unit for non-fatal decompensated HF events', 'timeFrame': '6 Month minimum'}, {'measure': 'Time-to-first HF-MACE (composite of hospital admissions for decompensated HF, urgent care outpatient HF visit, and successfully RCD events)', 'timeFrame': '6 Month minimum'}, {'measure': 'Time-to-first HF-MACE (composite of hospital admissions for decompensated HF, urgent care outpatient HF visit, successfully RCD events or TCE)', 'timeFrame': '6 Month minimum'}, {'measure': 'Time-to-cardiac death', 'timeFrame': '6 Month minimum'}, {'measure': 'Time-to-all-cause death', 'timeFrame': '6 Month minimum'}, {'measure': 'Time-to-first non-fatal MI (myocardial infarction), non-fatal CVA (cerebrovascular attack) or coronary artery revascularization', 'timeFrame': '6 Month minimum'}, {'measure': 'Left Ventricular (LV) remodeling in LVESV determined by 2-D echocardiography', 'timeFrame': 'Screening, day 0 (post-procedure), months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum)'}, {'measure': 'Correlations between baseline LVESV <=100 mL and LVESV >100 mL and clinical outcomes', 'timeFrame': '6 Month minimum'}, {'measure': 'Correlations between baseline LVESV <=100 mL and LVESV >100 mL and change in Month 6 to baseline LVESV and clinical outcomes', 'timeFrame': '6 Month minimum'}, {'measure': 'LV remodeling in LVEDV determined by 2-D echocardiography', 'timeFrame': 'Screening, day 0 (post-procedure), months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum)'}, {'measure': 'Overall Left Ventricular systolic performance as assessed by left ventricular ejection fraction (LVEF [radionuclide ventriculography {RVG} or echocardiogram])', 'timeFrame': 'Screening, day 0 (post-procedure), months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum)'}, {'measure': 'Functional exercise capacity as assessed by 6 Minute Walk Test', 'timeFrame': 'Screening, months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum)'}, {'measure': 'Functional status by New York Heart Association (NYHA) class', 'timeFrame': 'Screening, months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum)'}, {'measure': 'Quality of Life Measure - Minnesota Living With Heart Failure (MLHF) questionnaire', 'timeFrame': 'Screening, months 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum)'}, {'measure': 'Quality of Life Measure - European Quality of Life (EuroQoL) 5-dimensional (EQ-5D) questionnaire', 'timeFrame': 'Screening, months 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum)'}, {'measure': 'Safety as assessed by occurrence of adverse events related to the index cardiac catheterization on Day 0', 'timeFrame': 'Day 0 through discharge from Day 0 hospitalization'}, {'measure': 'Safety as assessed by occurrence of treatment-emergent adverse events', 'timeFrame': 'Screening through 6 Month minimum'}, {'measure': 'Safety as assessed by clinical laboratory tests (serum chemistry - ALT, AST, alkaline phosphate, GGT, LDH, BUN, creatinine, uric acid, total bilirubin - and hematology - hematocrit, hemoglobin, WBCs, eosinophils, ANC, platelet count)', 'timeFrame': 'Screening, day 0 (post-procedure), day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum)', 'description': 'ALT (alanine transaminase), AST (aspartate aminotransferase), GGT (gamma-glutamyl transferase), LDH (lactate dehydrogenase), BUN (blood urea nitrogen), WBCs (white blood cells), ANC (absolute neutrophil count)'}, {'measure': 'Safety as assessed by urinalysis (blood, glucose, ketones, total protein)', 'timeFrame': 'Screening, day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum)'}, {'measure': 'Safety as assessed by vital signs (pulse, systolic blood pressure [BP], diastolic BP)', 'timeFrame': 'Screening, day 0 (pre and post-procedure), day 1, day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum)'}, {'measure': "Safety as assessed by 12-lead electrocardiogram (ECG) findings - QT interval with Fridericia's correction (QTcF), heart rate-corrected QT interval (QTcB), QT, Q wave, R wave and S wave (QRS) complex, HR and T waves.", 'timeFrame': 'Screening, day 0 (pre and post-procedure), day 1, day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum)'}, {'measure': 'Safety as assessed by telemetry monitoring findings (clinically significant arrhythmias)', 'timeFrame': 'Day 0 through Day 0 overnight post-procedure'}, {'measure': 'Safety as assessed by rhythm analysis (specifically, ventricular arrhythmias) by interrogation of any implanted device capable of defibrillation', 'timeFrame': 'Day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum)'}, {'measure': 'Safety as assessed by 24-hr Holter monitoring (HR, rate & duration of arrhythmias, a-fib average rate, supra- & ventricular ectopy singles/couplets/runs/totals, sustained & non-sustained ventricular tachycardia, longest pauses RR duration, total pauses)', 'timeFrame': 'Screening, day 0 (post-procedure), day 10, months 1 and 3'}, {'measure': 'Safety as assessed by physical examination findings judged as clinically significant changes from baseline by the investigator or newly occurring abnormalities (including weight)', 'timeFrame': 'Screening, month 12 and every 12 months thereafter until study conclusion (weight measured at screening, day 0 - pre and post-procedure, day 1, day 10, months 1, 3, 6 and 12 and every 6 months thereafter)'}, {'measure': 'Safety as assessed by important cardiovascular events from adjudicated data', 'timeFrame': '6 Month minimum'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic Heart Failure', 'CHF', 'Left Ventricular Systolic Dysfunction', 'Ischemic Heart Failure', 'Nonischemic Heart Failure', 'Stem Cells', 'Allogeneic Mesenchymal Precursor Cells'], 'conditions': ['Chronic Heart Failure']}, 'referencesModule': {'references': [{'pmid': '31318648', 'type': 'DERIVED', 'citation': 'Borow KM, Yaroshinsky A, Greenberg B, Perin EC. Phase 3 DREAM-HF Trial of Mesenchymal Precursor Cells in Chronic Heart Failure. Circ Res. 2019 Jul 19;125(3):265-281. doi: 10.1161/CIRCRESAHA.119.314951. Epub 2019 Jul 18.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine whether transendocardial delivery of allogeneic human bone marrow-derived mesenchymal precursor cells (MPCs \\[rexlemestrocel-L\\]) is effective in the treatment of chronic heart failure (HF) due to left ventricular (LV) systolic dysfunction.', 'detailedDescription': 'The purpose of this study is to evaluate the efficacy and safety of a single transendocardial delivery in the cardiac catheterization laboratory of human bone marrow-derived allogeneic MPCs (rexlemestrocel-L) for improvement in clinical outcomes (heart failure major adverse cardiac events \\[HF-MACE\\]), preventing further adverse cardiac remodeling (left ventricular end systolic volume \\[LVESV\\] and left ventricular end-diastolic volume \\[LVEDV\\]), and increasing exercise capacity (six-minute walking test \\[6MWT\\]) in patients with chronic HF due to LV systolic dysfunction of either ischemic or nonischemic etiology who have received optimal medical/revascularization therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient is 18 to 80 years of age, inclusive; both men and women will be enrolled.\n* The patient has a diagnosis of chronic HF of ischemic or nonischemic etiology for at least 6 months\n* The patient is on stable, optimally tolerated dosages of HF therapies including beta-blockers (approved for country-specific usage), angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), and/or aldosterone antagonists, without change in dose for at least 1 month before study intervention\n* The patient is on a stable, outpatient, oral diuretic dosing regimen in which the patient remains clinically stable during screening.\n* Other Criteria apply, please contact the investigator\n\nExclusion Criteria:\n\n* The patient has NYHA Functional Class I or Functional Class IV symptoms.\n* Other Criteria apply, please contact the investigator'}, 'identificationModule': {'nctId': 'NCT02032004', 'acronym': 'DREAM HF-1', 'briefTitle': 'Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mesoblast, Ltd.'}, 'officialTitle': 'Double-blind, Randomized, Sham-procedure-controlled, Parallel-Group Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) in Chronic Heart Failure Due to LV Systolic Dysfunction (Ischemic or Nonischemic) Dream HF-1', 'orgStudyIdInfo': {'id': 'MSB-MPC-CHF001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Allogeneic Mesenchymal Precursor Cells', 'description': 'Participants randomly assigned to treatment will undergo a single index cardiac catheterization involving transendocardial delivery of rexlemestrocel-L into the myocardium at a cell injection center by an interventional cardiology team not involved with review or assessment of subsequent study results.', 'interventionNames': ['Biological: Allogeneic Mesenchymal Precursor Cells (MPCs)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control Treatment', 'description': 'Participants randomly assigned to control treatment will undergo a single cardiac catheterization involving a scripted sham cardiac mapping and cell delivery procedure at a cell injection center by an interventional cardiology team not involved with review or assessment of subsequent study results.', 'interventionNames': ['Other: Sham Comparator']}], 'interventions': [{'name': 'Allogeneic Mesenchymal Precursor Cells (MPCs)', 'type': 'BIOLOGICAL', 'otherNames': ['MPCs', 'rexlemestrocel-L'], 'description': 'Rexlemestrocel-L consists of human bone marrow-derived allogeneic MPCs isolated from bone mononuclear cells with anti-STRO-3 antibodies, expanded ex vivo, and cryopreserved', 'armGroupLabels': ['Allogeneic Mesenchymal Precursor Cells']}, {'name': 'Sham Comparator', 'type': 'OTHER', 'description': 'The sham procedure will be staged to script and will not include actual cardiac mapping or delivery of rexlemestrocel-L.', 'armGroupLabels': ['Control Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35211', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10757 - Cardiology, P.C.', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 13262 - University of Alabama at Birmingham Hospital', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85297', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10779 - Mercy Gilbert Medical Center', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85206', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10786 - Cardiovascular Associates of Mesa', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10756 - Mayo Clinic', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 13023 - University of Arizona Medical Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10754 - University of California, San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10759 - Scripps Clinic', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 13265 - University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90211', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10775 - Cedars-Sinai Medical Care Foundation', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10778 - Orange County Cardiology', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '93030', 'city': 'Oxnard', 'state': 'California', 'country': 'United States', 'facility': "Mesoblast Investigational Site 13031 - St. John's Regional Medical Center", 'geoPoint': {'lat': 34.1975, 'lon': -119.17705}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 13275 - Stanford University Hospital', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '33435', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 13267 - Bethesda Heart Hospital', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10780 - Morton Plant Hospital', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10760 - Shands Hospital, University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 13273 - University of Florida Health', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33215', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10768 - University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 13280', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 13264 - Florida Hospital Pepin Heart Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 13027 - Emory University School of Medicine', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10765 - Georgia Regents University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10772 - University Cardiologist, Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 13030 - University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10783 - Gill Heart Institute, University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 13022 - University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 13266', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10782', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48602', 'city': 'Saginaw', 'state': 'Michigan', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10766 - Michigan Cardiovascular Institute', 'geoPoint': {'lat': 43.41947, 'lon': -83.95081}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10762 - Minneapolis Heart Institute', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10761 - Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 13281', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '07112', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 13263 - RWJ Barnabas Heart Center', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10776 - Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 13026 - Sanger Heart and Vascular Institute, Carolinas Healthcare System', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10781 - Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10758 - The Christ Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10770 - University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10773', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43214', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 13278 - OhioHealth Research Institute', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '18103', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10785 - Lehigh Valley Hospital', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 13261 - University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10767 - Temple University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 13277', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10774 - University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '38125', 'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10777 - Stern Cardiovascular Foundation', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '78756', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 13024 - Austin Heart, PLLC', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75226', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 13274 - Soltero CV Research Center, Baylor Scott & White Research Institute', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10755 - Texas Heart Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 13268 - Houston Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10763 - University Hospital', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10771 - Heart & Vascular Research, Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10764 - University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10769 - Aurora Healthcare', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 13279', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '54401', 'city': 'Wausau', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Mesoblast Investigational Site 10789 - Aspirus Research Institute', 'geoPoint': {'lat': 44.95914, 'lon': -89.63012}}, {'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Mesoblast Investigational Site 11027', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V8R 4R2', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Mesoblast Investigational Site 11024 - Victoria Heart Institute Foundation', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "Mesoblast Investigational Site 11025 - St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Fred Grossman, DO', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mesoblast, Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mesoblast, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-10-02', 'type': 'RELEASE'}, {'date': '2025-10-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Mesoblast, Inc.'}}}}