drugset / Trial / NCT01458405
Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration
Phase 1/2
Terminated
135 enrolled
Capricor Inc.
California Institute for Regenerative Medicine (CIRM) · collabNational Heart, Lung, and Blood Institute (NHLBI) · collabNational Institutes of Health (NIH) · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to determine whether Allogeneic Cardiosphere-Derived Cells (CAP-1002) is safe and effective in decreasing infarct size in patients with a myocardial infarction.
Timeline
- Start
- 2012-11-13
- Primary completion
- 2017-07-03
- Completion
- 2019-02-28
Outcome
Outcome not reported
Stopped: “On February 28, 2019, Capricor ceased ongoing follow-up activities and terminated the ALLSTAR trial to focus resourcing on its active CAP-1002 program, HOPE-2.”
Publications
- Ostovaneh MR, Makkar RR, Ambale-Venkatesh B, Ascheim D, Chakravarty T, Henry TD, Kowalchuk G, Aguirre FV, Kereiakes DJ, Povsic TJ, Schatz R, Traverse JH, Pogoda J, Smith RD, Marban L, Marban E, Lima JAC. Effect of cardiosphere-derived cells on segmental myocardial function after myocardial infarction: ALLSTAR randomised clinical trial. Open Heart. 2021 Jul;8(2):e001614. doi: 10.1136/openhrt-2021-001614.
- Makkar RR, Kereiakes DJ, Aguirre F, Kowalchuk G, Chakravarty T, Malliaras K, Francis GS, Povsic TJ, Schatz R, Traverse JH, Pogoda JM, Smith RR, Marban L, Ascheim DD, Ostovaneh MR, Lima JAC, DeMaria A, Marban E, Henry TD. Intracoronary ALLogeneic heart STem cells to Achieve myocardial Regeneration (ALLSTAR): a randomized, placebo-controlled, double-blinded trial. Eur Heart J. 2020 Sep 21;41(36):3451-3458. doi: 10.1093/eurheartj/ehaa541.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Deramiocel | Cell therapy | 2.5e+07 cells | Other |