The ALLogeneic Heart STem Cells to Achieve Myocardial Regeneration (ALLSTAR) trial is a Phase I/II trial evaluating the safety and efficacy of the CAP-1002 therapeutic candidate– Capricor’s allogeneic, off-the-shelf, cardiosphere-derived cell product candidate. The trial is being sponsored by Capricor, and Drs. Timothy Henry and Rajendra Makkar of the Cedars-Sinai Heart Institute are the principal investigators. The trial is being conducted at approximately 30 sites across the U.S and in Canada.

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 with the support of the California Institute for Regenerative Medicine (CIRM).

Status of Study:

Overall: Enrollment complete.

Phase I: Enrollment complete.

Phase II: Enrollment complete.

Study Design:

The ALLSTAR trial began with an open-label cohort (Phase I) and has now progressed to a double-blind, randomized, placebo-controlled study (Phase II) designed to maximize the study’s ability to assess both the safety and efficacy of CAP-1002. The National Heart, Lung and Blood Institute Data and Safety Monitoring Board has approved advancement to the Phase II clinical trial.

Patients considered for participation in the Phase II portion of the study were those who had a heart attack between 30 days and one year prior. After completion of screening procedures, patients were randomized to receive either CAP-1002 or placebo in a 2:1 ratio favoring CAP-1002, which was administered via infusion into the infarct related artery (coronary). The product’s effectiveness will be assessed by reduction in infarct (scar) size after one year, similar to that which was achieved in the proof-of-concept CADUCEUS trial sponsored by Cedars-Sinai Medical Center using autologous CDCs. However, since the patients in CADUCEUS already had smaller heart attack scar size by six-months after treatment, Capricor will also look at that interim data as an indicator of efficacy.

Patient Population:

Patients who have had a heart attack due to coronary artery atherosclerotic disease within the prior 12 month period, have less than normal heart function as evidenced by left ventricular ejection fraction (LVEF) ≤45% and infarct (scar) size of ≥15% of left ventricular mass. To view the full list of inclusion and exclusion criteria, please visit (NCT01458405).

More Information:

Please visit (NCT01458405) for more information regarding the ALLSTAR Phase I/II clinical trial.