Cardiac Repair Cells Used for the Treatment of Chronic Heart Failure

The first clinical trial has been initiated in the United States to evaluate the surgical delivery of autologous cells directly into human heart muscle for the treatment of dilated cardiomyopathy- (DCM)-related congestive heart failure.

Aastrom Biosciences, Inc. (Ann Arbor, MI, USA), a leading regenerative medicine company, reported that the first patient has been treated in its randomized, controlled, prospective, open-label IMPACT-DCM clinical trial. Currently enrolling patients at The Methodist Hospital (Houston, TX, USA), Baylor University Medical Center (Dallas, TX, USA), and the University of Utah School of Medicine (Salt Lake City, USA), the U.S. phase II clinical trial has been designed to evaluate Aastrom Biosciences' product, cardiac repair cells (CRCs), in the treatment of DCM, a severe form of chronic heart failure. Dr. Amit Patel, associate professor of surgery at the University of Utah School of Medicine, is the lead investigator for this trial.

IMPACT-DCM is the first clinical trial in the United States 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. CRCs, manufactured using Aastrom's Tissue Repair Cell (TRC) technology, previously received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of DCM.

"Following our initial positive experience with compassionate use treatments in Germany, we are pleased to advance this promising cardiac regeneration treatment to the clinic in the U.S.,” said George Dunbar, president and chief executive officer of Aastrom. "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.”

The first patient surgery in the IMPACT-DCM trial took place at the Methodist DeBakey Heart & Vascular Center (Methodist) in Houston, TX, USA. The procedure was performed by Dr. Brian Bruckner, cardiac surgeon at Methodist and lead investigator of the trial at the clinical site; Dr. Michael Reardon, chief of cardiac surgery at Methodist and a coinvestigator of the trial; and Dr. Matthias Loebe, transplant surgeon at Methodist and a coinvestigator of the trial.

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 United States. 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.

Many of the individuals suffering from severe heart failure have DCM, a condition where expansion of the patient's heart reduces pump function, making it impossible to maintain normal blood circulation. Patients with DCM typically have symptoms of congestive heart failure, including severe limitations in physical activity and shortness of breath. DCM typically occurs in patients who have ischemic heart failure due to multiple heart attacks, although it can also be found in patients with non-ischemic heart failure caused by hypertension, viral infection, or alcoholism. Patient prognosis depends upon the stage of the disease, but it is generally characterized by numerous health problems and a very high mortality rate.

Aastrom is a developer of autologous cell products for the repair or regeneration of human tissue. The company's proprietary TRC technology involves the use of a patient's own cells to manufacture products to treat a range of chronic diseases and serious injuries. Aastrom's TRC-based products contain increased numbers of stem and early progenitor cells, produced from a small amount of bone marrow collected from the patient.

The TRC technology platform has positioned Aastrom to advance multiple products into clinical development. Ongoing development activities are focused on applying TRC technology to cardiac and vascular tissue regeneration. The company is currently focused on cardiovascular regeneration, conducting a phase IIb clinical trial with critical limb ischemia (CLI) patients (the RESTORE-CLI trial).

Related Links:
Aastrom Biosciences
Methodist Hospital
Baylor University Medical Center
University of Utah School of Medicine