Currently enrolling patients at The Methodist Hospital in Houston, Texas, Baylor University Medical Center in Dallas, Texas and The University of Utah School of Medicine in Salt Lake City, Utah, the US Phase II clinical trial is designed to evaluate the company’s cardiac repair cells (CRCs) in the treatment of dilated cardiomyopathy (DCM), a severe form of chronic heart failure.
Aastrom said that IMPACT-DCM is the first clinical trial in the US to evaluate the surgical delivery of autologous cells directly into human heart muscle for the treatment of DCM-related congestive heart failure. Patients are treated with Aastrom’s CRCs, an autologous, mixed-cell product containing expanded populations of stem and early progenitor cells designed to treat patients with end-stage DCM.
The Phase II study seeks to enroll 20 patients with ischemic DCM and 20 patients with non-ischemic DCM at five clinical sites in the US. Participants must have a left ventricular ejection fraction (LVEF) of less than or equal to 30% (60-75% is typical for a healthy person) and meet certain other eligibility criteria.
The study protocol states that patients in each group will receive standard medical care and 75% of patients will be treated with CRCs through direct injection into the heart muscle during minimally invasive open heart surgery.
While the primary objective of this study is to assess the safety of CRCs in patients with DCM, efficacy measures including LVEF, heart failure stage and other measures of cardiac function will be monitored. The company intends to follow patients in the study for 12 months post treatment.
George Dunbar, president and CEO of Aastrom, said: “We are pleased with the momentum this trial is gathering. Three of the five clinical sites are currently ready to enroll patients, and we look forward to having all five sites actively recruiting patients into this multi-center study.”