Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure
Completed · Phase 3 · Has a placebo group
Conditions studied: Chronic Heart Failure
In brief
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.
Key facts
- Study ID
- NCT02032004
- Run by
- Mesoblast, Inc.
- People needed
- 565
- Starts
- 2014-03-03
- Expected to finish
- 2020-01-30
- Last updated by the study team
- 2026-03-23
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- The participant is 18 to 80 years of age, inclusive; both men and women will be enrolled.
- The participant has a diagnosis of chronic HF of ischemic or nonischemic etiology for at least 6 months
- The participant 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
- The participant is on a stable, outpatient, oral diuretic dosing regimen in which the participant remains clinically stable during screening.
- Other Criteria apply, please contact the investigator
You may not qualify if…
- The participant has NYHA Functional Class I or Functional Class IV symptoms.
- Other Criteria apply, please contact the investigator
Where it is running
- Mesoblast Investigational Site 13262 - University of Alabama at Birmingham Hospital — Birmingham, Alabama, United States
- Mesoblast Investigational Site 10779 - Mercy Gilbert Medical Center — Gilbert, Arizona, United States
- Mesoblast Investigational Site 10786 - Cardiovascular Associates of Mesa — Mesa, Arizona, United States
- Mesoblast Investigational Site 10756 - Mayo Clinic — Phoenix, Arizona, United States
- Mesoblast Investigational Site 13023 - University of Arizona Medical Center — Tucson, Arizona, United States
- Mesoblast Investigational Site 10754 - University of California, San Diego — La Jolla, California, United States
- Mesoblast Investigational Site 10759 - Scripps Clinic — La Jolla, California, United States
- Mesoblast Investigational Site 13265 - University of California, Los Angeles — Los Angeles, California, United States
- Mesoblast Investigational Site 10775 - Cedars-Sinai Medical Care Foundation — Los Angeles, California, United States
- Mesoblast Investigational Site 10778 - Orange County Cardiology — Orange, California, United States
- Mesoblast Investigational Site 13031 - St. John's Regional Medical Center — Oxnard, California, United States
- Mesoblast Investigational Site 13275 - Stanford University Hospital — Stanford, California, United States
- Mesoblast Investigational Site 13267 - Bethesda Heart Hospital — Boynton Beach, Florida, United States
- Mesoblast Investigational Site 10780 - Morton Plant Hospital — Clearwater, Florida, United States
- Mesoblast Investigational Site 10760 - Shands Hospital, University of Florida — Gainesville, Florida, United States
- Mesoblast Investigational Site 13273 - University of Florida Health — Jacksonville, Florida, United States
- Mesoblast Investigational Site 10768 - University of Miami — Miami, Florida, United States
- Mesoblast Investigational Site 13280 — Orlando, Florida, United States
- Mesoblast Investigational Site 13264 - Florida Hospital Pepin Heart Institute — Tampa, Florida, United States
- Mesoblast Investigational Site 13027 - Emory University School of Medicine — Atlanta, Georgia, United States
- Mesoblast Investigational Site 10765 - Georgia Regents University — Augusta, Georgia, United States
- Mesoblast Investigational Site 10772 - University Cardiologist, Rush University Medical Center — Chicago, Illinois, United States
- Mesoblast Investigational Site 13030 - University of Iowa — Iowa City, Iowa, United States
- Mesoblast Investigational Site 10783 - Gill Heart Institute, University of Kentucky — Lexington, Kentucky, United States
- Mesoblast Investigational Site 10757 - Cardiology, P.C. — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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