drugset / Trial / NCT02503280
The Transendocardial Autologous Cells (hMSC) or (hMSC) and (hCSC) in Ischemic Heart Failure Trial.
RandomizedParallel-groupSingle-blindTreatment
Summary
Before initiating the full randomized study, a Pilot Safety Phase will be performed. In this phase the composition of cells administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested. The randomized portion of the study will be conducted after a full review of the safety data from the pilot Phase by the Data safety monitoring board. Following the Pilot Phase of five (5) Fifty (50) patients scheduled to undergo cardiac catheterization and meeting all inclusion/exclusion criteria will be evaluated at baseline. Patients will be randomized in a 2:2:1 ratio to one of three Treatment Strategies.
Timeline
- Start
- 2025-03-01
- Primary completion
- 2030-03
- Completion
- 2032-03
Outcome
Outcome not reported
Stopped (Enrollment): “Study has never enrolled any subjects”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Autologous Human C-Kit CSCs II | Unknown | 1e+06 cells | Other |
| Subject | Autologous hMSCs | Unknown | 1.99e+08 cells | Other |
| Subject | Autologous hMSCs | Unknown | 2e+08 cells | Other |