Safety and efficacy of ixmyelocel-T an expanded, autologous multi-cellular therapy, in dilated cardiomyopathy

Timothy D. Henry, Jay H. Traverse, Baron L. Hammon, Cara A. East, Brian Bruckner, Ann E. Remmers, David Recker, David A. Bull, Amit N. Patel

Research output: Contribution to journalArticle

35 Scopus citations

Abstract

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 minithoracotomy or intramyocardial catheter injections in patients with dilated cardiomyopathy (DCM) stratified by ischemic or nonischemic status. Methods and Results: In IMPACT-DCM, patients were randomized to either ixmyelocel-T or standard-ofcare control in a 3:1 ratio (n=39); ixmyelocel-T was administered intramyocardially via minithoracotomy. 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 2 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 during follow-up when compared with control patients. A similar benefit was not seen in the nonischemic patients. Heart failure exacerbation was the most common major adverse cardiovascular event. Ixmyelocel-T treatment was associated with improved New York Heart Association 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 nonischemic population. Conclusions: Intramyocardial injection with ixmyelocel-T reduces major adverse cardiovascular event and improves symptoms in patients with ischemic DCM but not in patients with nonischemic DCM.

Original languageEnglish (US)
Pages (from-to)730-737
Number of pages8
JournalCirculation Research
Volume115
Issue number8
DOIs
StatePublished - 2014

Keywords

  • Cardiomyopathy, dilated
  • Clinical trial
  • Heart failure
  • Stem cell

ASJC Scopus subject areas

  • Physiology
  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

Fingerprint Dive into the research topics of 'Safety and efficacy of ixmyelocel-T an expanded, autologous multi-cellular therapy, in dilated cardiomyopathy'. Together they form a unique fingerprint.

Cite this