The Dilated cardiomYopathy iNtervention with Allogeneic MyocardIally-regenerative Cells (DYNAMIC) Phase I trial evaluated CAP-1002 in patients with advanced heart failure.

The DYNAMIC trial evaluated CAP-1002 for the first time in patients who have advanced heart failure. These patients have progressed to a more advanced stage of the disease than patients being evaluated in the ALLSTAR trial. Patients received CAP-1002 in up to three coronary arteries, enabling delivery of the drug product to more of the diseased heart tissue. Additionally, the cells were delivered using a non-stop flow technique. Other cell therapies use a balloon to stop blood flow during the infusion procedure, which could potentially damage blood vessels and cause chest discomfort in patients. The non-occlusive intracoronary infusion delivery method used in DYNAMIC is likely to provide more comfort for patients – without compromising efficacy – as blood flow will not be stopped during infusion.

Study Status:

Phase I: Completed, not enrolling

Study Design:

The Phase I DYNAMIC trial is designed as an open-label, single center study evaluating the safety of CAP-1002 in 14 patients. The Phase I trial was funded in part by a grant from the National Institutes of Health.

Patient Population:

Patients with ischemic or non-ischemic dilated cardiomyopathy with left ventricular ejection fraction ≤ 35%; NYHA Class III or ambulatory Class IV heart failure.

More Information:

Please visit ClinicalTrials.gov (NCT02293603) for more information regarding the DYNAMIC clinical trial.