Safety and Efficacy of Ixmyelocel-T: An Expanded, Autologous Multi-Cellular Therapy, in Dilated Cardiomyopathy
Rationale: Ixmyelocel-T is associated with a wide range of biological activities relevant to tissue repair and regeneration.
Objective: To evaluate the safety and efficacy of ixmyelocel-T in 2 prospective randomized Phase 2A Trials administered via mini-thoracotomy or intramyocardial catheter injections in patients with dilated cardiomyopathy (DCM) stratified by ischemic or non-ischemic status.
Methods and Results: In IMPACT-DCM patients were randomized to either ixmyelocel-T or standard of care control in a 3:1 ratio (n=39) and ixmyelocel-T was administered intramyocardially via mini-thoracotomy. In Catheter-DCM patients were randomized to either ixmyelocel-T or standard of care control in a 2:1 ratio (n=22); ixmyelocel-T was administered intramyocardially using the NOGA® Myostar catheter. Only patients randomized to ixmyelocel-T underwent bone marrow aspiration and injections. In the two studies, a total of 61 patients were randomized, and 59 were treated or received standard of care. Fewer ischemic patients treated with ixmyelocel-T experienced a major adverse cardiovascular event (MACE) during follow up compared to control patients. A similar benefit was not seen in the non-ischemic patients. Heart failure (HF) exacerbation was the most common MACE. Ixmyelocel-T treatment was associated with improved NYHA Class, 6-minute walk distance, and Minnesota Living with Heart Failure Questionnaire scores in the ischemic population relative to control; a similar trend was not observed in the non-ischemic population.
Conclusions: Intramyocardial injection with ixmyelocel-T reduces MACE and improves symptoms in patients with ischemic DCM but not non-ischemic DCM.
- Clinical Studies
- Stem Cell Therapy
- heart failure
- stem cell
- dilated cardiomyopathy
- clinical trial
- Received June 5, 2014.
- Revision received August 19, 2014.
- Accepted August 20, 2014.