Aastrom Biosciences, Inc, a leading regenerative medicine company, announced 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 in Houston, TX, Baylor University Medical Center in Dallas, TX and The University of Utah School of Medicine in Salt Lake City, UT, 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. Dr Amit Patel, associate professor of Surgery at the University of Utah School of Medicine, is the National Principal Investigator for this trial.

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. CRCs, manufactured using Aastrom's Tissue Repair Cell (TRC) technology, previously received Orphan Drug Designation from the 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 US," 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 enrol 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. The procedure was performed by Dr. Brian Bruckner, Cardiac Surgeon at Methodist and Principal Investigator of the trial at the clinical site; Dr. Michael Reardon, chief of Cardiac Surgery at Methodist and a Co-Investigator of the trial; and Dr Matthias Loebe, transplant surgeon at methodist and a co-investigator of the trial.

The phase-II study seeks to enrol 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.

"This is the first clinical trial designed to target both ischemic and non-ischemic DCM," said Dr Elmar Burchardt, vice president, Medical Affairs of Aastrom. "In the US alone, there are 1.8 million patients with severe heart failure, which includes 120,000-150,000 patients suffering from DCM."

Many of the 5.5 million people in the US 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 generally occurs in patients who have ischemic heart failure due to multiple heart attacks, though 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 is typically characterized by numerous health problems and a very high mortality rate.

Aastrom is a leader in the development of autologous cell products for the repair or regeneration of human tissue.