DCM Clinical Trials

Advancing stem cell therapies
for the treatment of congestive heart failure

Dilated cardiomyopathy (DCM) is the most common form of heart failure (HF). The American Heart Association estimates that 4.9 million people in the Unites States have heart failure (www.americanheart.org).  Dilated cardiomyopathy, a progressive disease of heart muscle, is the third most common cause of heart failure (www.americanheart.org) and the most frequent cause of heart transplantation. The word dilated refers to the enlarged state of the heart in DCM, and the word cardiomyopathy means disease of the heart muscle.  To read more about dilated cardiomyopathy, visit our dilated cardiomyopathy page in the Cardiovascular Disease Patients section of our website. Below is information about the status of Aastrom’s DCM clinical trials.

 


ixCell DCM logo

IXCELL-DCM (55-1202-1)

Status: Recruiting

Study design: Phase 2b, double blind, placebo controlled, prospective, randomized, multicenter

Patients: Patients must have a diagnosis of ischemic dilated cardiomyopathy based on WHO criteria, symptomatic heart failure in NYHA class III or IV, left ventricular ejection fraction of less than or equal to 30%, and no other cardiac intervention options likely to improve clinical status.

Purpose: To assess the efficacy and safety of ixmyelocel-T delivered by catheter and transendocardial injection in patients with DCM.

Locations: Multiple sites in the United States

Publications based on study: None

You may also view more complete information about this study (55-1202-1) on ClinicalTrials.gov, a registry of clinical trials conducted in the United States and around the world.

 

CATHETER-DCM (55-0811-1)

Status: Not Enrolling

Study design: Phase 2a, open-label, prospective, randomized, multicenter

Patients: Patients must have a diagnosis of ischemic or non-ischemic dilated cardiomyopathy based on WHO criteria, symptomatic heart failure in NYHA class III or IV, left ventricular ejection fraction of ~30%, and no other cardiac intervention options likely to improve clinical status.

Purpose: To assess the safety of ixmyelocel-T delivered by catheter and transendocardial injection in patients with DCM. Two strata will be used: ischemic dilated cardiomyopathy (IDCM) and non-ischemic dilated cardiomyopathy (NIDCM).

Locations: Multiple sites in the United States

Publications based on study: None

You may also view more complete information about this Catheter (55-0811-1) study on ClinicalTrials.gov, a registry of clinical trials conducted in the United States and around the world.

 


IMPACT-DCM (55-0712-1)

Status: Completed

Study design: Phase 2a, open-label, prospective, randomized, multicenter

Patients: Patients with a diagnosis of ischemic or non-ischemic dilated cardiomyopathy based on WHO criteria, symptomatic heart failure in NYHA class III or IV, left ventricular ejection fraction of ~30%, and no other cardiac intervention options likely to improve clinical status.

Purpose: To assess the safety and tolerability of ixmyelocel T surgically delivered compared to standard-of-care in patients with dilated cardiomyopathy (DCM).

Locations: Multiple sites in the United States

Publications based on study: Abstract: AN Patel, BL Hamman, B Bruckner, OM Lattouf, et al. Safety and Efficacy of Ixmyelocel-T, an Expanded Patient-Specific Mixed Cell Product, in Dilated Cardiomyopathy (IMPACT-DCM) Journal of Cardiac Failure Vol. 17, Issue 8, Supplement, Page S58.  You may also view the poster presentation on the Aastrom News and Events tab on the website.