Capricor's ALLSTAR Phase I/II clinical trial is evaluating its CAP-1002 allogeneic cardiac-derived cell (CDC) product candidate in reducing infarct (scar) size in patients who have suffered a heart attack. The estimated 300-patient, double-blind, randomized, placebo-controlled Phase II portion of the ALLSTAR clinical trial is powered to detect a reduction in infarct size as measured by MRI in patients following a large myocardial infarction more than 30 days and less than 12 months prior to treatment with CAP-1002. The trial is sub-randomized into an 'early' group (30-90 days post-heart attack) and a 'late' group (91-365 days post-heart attack). Each group is powered sufficiently to provide both a safety and efficacy readout. Phase I of the ALLSTAR trial was funded in part by a grant received from the NIH. Phase II is being funded with the support of the
"The fact that donor heart CDC cells were introduced into patients following a myocardial infarction and produced no adverse clinical effects in the 14-patient Phase I cohort marks a major milestone for the field of cardiac cell therapy," said
Capricor CEO Dr.
In the prospective, randomized Phase I Intracoronary Cardiosphere-Derived Cells for Heart Regeneration after Myocardial Infarction (CADUCEUS) clinical trial, 24 patients received CDC treatment. The trial provided early evidence for cardiac regeneration as autologous CDC patients saw scars left by myocardial infarction shrink over the course of 12 months and scientists observed a significant correlation between scar shrinkage and increases in viable tissue suggesting regeneration of new viable heart muscle. CDC patients also demonstrated improved regional function and trends pointing toward the reversal of adverse cardiac remodeling. About
CAP-1002 is currently not an approved product and is strictly for investigational purposes. About Cenderitide Cenderitide, a novel chimeric natriuretic peptide, is a first-in-class dual guanylyl cyclase receptor activator. Chronic dual receptor activation using a continuous subcutaneous infusion of Cenderitide is being studied to test whether its combination of tissue protective, renal protective and cardiac unloading effects will help stabilize the patient's heart and kidney function, preventing the worsening of heart failure symptoms and re-admissions to the hospital. Cenderitide is under clinical development to treat heart failure patients during the post-acute heart failure (P-AHF) period, which is the 90-day period immediately after discharge from a hospitalization for acute decompensated heart failure. The P-AHF period is often associated with a worsening of heart failure symptoms or renal function and rates of re-admission and mortality can be as high as 40%.
Keywords for this news article include: Biotechnology, Biomedical Engineering, Biomedicine, Pharmaceuticals, Treatment, Cardiology, Cell Therapy, Bioengineering, Biological Therapy, Regenerative Medicine,
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