ALLSTAR

ALLSTAR Phase I/II

ALLSTAR

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 began enrolling in late 2012 and is expected to enroll 314 patients in total (Phase I n=14, Phase II n=260-300) at 25-35 sites across the U.S.

The Phase I portion of the trial was funded in part by the National Institutes of Health, and the Phase II portion of the trial is supported in large part by the California Institute for Regenerative Medicine (CIRM).


Status of Study:

Overall: Enrolling

Phase I: Enrollment complete.

Phase II: Currently enrolling patients.

Enrollment must occur through a health care provider at a site participating in the study. If you would like to be considered for inclusion in the study, please speak with your cardiologist or call the HELP line at Cedars-Sinai Medical Center at 1(855) 783-6967. Visit the ALLSTAR trial page on ClinicalTrials.gov to locate the active site nearest to you.


Study Design:

The ALLSTAR trial began in late 2012 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 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 being considered for participation in the Phase II portion of the study are those who have had a heart attack between 30 days and one year prior. After completion of screening procedures, patients will be randomized to receive either CAP-1002 or placebo in a 2:1 ratio favoring CAP-1002, which will be 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. However, since the patients in CADUCEUS already had smaller heart attack scar size by six-months after treatment, Capricor will 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 past year, 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 ClinicalTrials.gov (NCT01458405).


More Information:

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