DCM Clinical Trials
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 HF and of these 33% are estimated to have DCM. To read more about dilated cardiomyopathy, visit our dilated cardiomyopathy page in the For Patients section of our website. Below is information about the status of Aastrom’s DCM clinical trials.
Clinical Trial Information for Dilated Cardiomyopathy
Status: Active not enrolling patients
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: A.N. Patel, B. L. Hamman, B. Bruckner, O. M. 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 more complete information about the Impact-DCM (55-0712-1) study on ClinicalTrials.gov, a registry of clinical trials conducted in the United States and around the world.
Clinical Trial Information for Dilated Cardiomyopathy
Status: Active not enrolling patients
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.