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4/12/2010 Stem Cell Study at Minneapolis Heart Institute Foundation meets Phase 2 goal
Week of 4/12/2010:
FOR IMMEDIATE RELEASE - Stem cell study at Minneapolis Heart Institute Foundation meets Phase 2 goal. Read more here.
Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital has completed enrolling patients in RESTORE-CLI, currently the world’s largest stem cell therapy study for critical limb ischemia (CLI). CLI is the end-stage of peripheral arterial disease.
“The completion of this study is a milestone in the development of vascular regeneration,” said Tim Henry, M.D., cardiologist and research director at the Minneapolis Heart Institute Foundation. “While we don’t know the results of Phase 2 yet, the fact that the company is looking toward Phase 3 means this therapy is safe. Now we’ll study how well it works.”
People with CLI face a high risk of amputation and, in some cases, death. Approximately one million people in the U.S. suffer from CLI, which results in more than 160,000 amputations each year.
Aastrom Biosciences, Inc. announced plans on March 24 to initiate Phase 3 planning discussions with the FDA and report six-month interim results for all enrolled patients later this year.
Aastrom's RESTORE-CLI trial enrolled a total of 86 patients at 18 sites in the United States, including the Minneapolis Heart Institute Foundation. Patients in the treatment group received intramuscular injections of TRCs into the affected limb, while control patients received intramuscular injections with an electrolyte solution (without cells). Both groups also received appropriate standard of care for their condition.
While the primary objective of this trial is to assess safety in patients with CLI, additional efficacy measures are also being monitored, including time to treatment failure (where failure is defined as major amputation, doubling of wound size or new gangrene), amputation rate, wound size and severity. Ankle brachial pressure index, pain and quality of life are also being monitored. Patients are being evaluated at both six months and 12 months following treatment.
TRC-based cellular therapies are produced from a small sample of bone marrow taken from a patient. Aastrom's TRC technology greatly expands the cell populations for direct delivery to the damaged tissues of the same patient.
About the Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital
The Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital is creating a world without heart disease through groundbreaking clinical research and innovative educational programs.
Abbott Northwestern Hospital is part of Allina Hospitals & Clinics, a not-for-profit family of hospitals, clinics and other care services dedicated to meeting the lifelong health care needs of communities throughout Minnesota and western Wisconsin.
About Aastrom Biosciences
Aastrom Biosciences is developing autologous cellular therapies for use in the treatment of severe cardiovascular diseases. The company's proprietary cell-processing technology enables the production of cellular therapies using a patient's own bone marrow that can be delivered directly to damaged tissues. Aastrom has advanced this technology into late-stage clinical development and is conducting two Phase 2 clinical trials to treat dilated cardiomyopathy and a Phase 2b clinical trial to treat critical limb ischemia. For more information, please visit Aastrom's website at www.aastrom.com.
