ALLSTAR Phase I/II
The ALLogeneic Heart STem Cells to Achieve Myocardial Regeneration (ALLSTAR) trial is a Phase I/II trial evaluating the safety and efficacy of lead therapeutic candidate, CAP-1002 – Capricor’s allogeneic, off-the-shelf, cardiosphere-derived cell product. The trial is being sponsored by Capricor and is led by Drs. Timothy Henry and Rajendra Makkar of the Cedars-Sinai Heart Institute. The trial is expected to enroll up to 314 patients in total (Phase I n=14, Phase II n=up to 300) at approximately 25-40 sites across the U.S.
The Phase I portion of the trial was funded in part by the National Institutes of Health and completed enrollment in December 2013, and the Phase II portion of the trial is supported in large part by the California Institute for Regenerative Medicine (CIRM).
Please visit ClinicalTrials.gov (NCT01458405) for more information regarding the ongoing ALLSTAR Phase I/II clinical trial.