Administration of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy
The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called human allogeneic mesenchymal stem cell therapy.
| Condition(s) | Non-ischemic Dilated Cardiomyopathy |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called human allogeneic mesenchymal stem cell therapy. |
| Who can participate | Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Men and women aged 18 to 80 years (inclusive) at the time of signing the informed consent form. 2. Diagnosis of NIDCM with left ventricular ejection fraction ≤45%. 3. Appropriate guideline-directed optimal medical therapy for non-ischemic cardiomyopathy. At a minimum, subjects must be on beta blockers and angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) or Angiotensin Receptor Neprilysin Inhibitors (ARNI) or have appropriate medical indication precluding use of one or both of these agents. Subjects must be on a stable regimen for at least 30 days prior to the procedure. Dose titration is allowed. 4. Be a candidate for card |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Joshua M Hare |
| Locations | Stanford, California, United States; Miami, Florida, United States; Louisville, Kentucky, United States; Houston, Texas, United States |
| Start date | 2021-05-07 |
| NCT ID | NCT04476901 |
| Official listing | https://clinicaltrials.gov/study/NCT04476901 |