Aastrom Announces Treatment of First Patient in U.S. Phase II IMPACT-DCM Trial
News Nov 25, 2008
Aastrom Biosciences, Inc. has 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 U.S.
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 U.S. 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 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. 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.
"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 U.S. alone, there are 1.8 million patients with severe heart failure, which includes 120,000-150,000 patients suffering from DCM."
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