Drexel University College of Medicine First in Region to Evaluate
Drexel University College of Medicine is the firstin the region to participate in a national research study evaluating a stem cell therapy for patients following a heart attack.
Online, January 26, 2010 (Newswire.com) - PHILADELPHIA (January 25, 2010) - Drexel University College of Medicine is the first and only medical center in the region to participate in a national research study evaluating a stem cell therapy for patients following a heart attack. The therapy, Prochymal®, is a formulation of adult stem cells that may have the ability to reduce inflammation and promote heart cell regeneration.
The goal of this Phase II Clinical Trial is to evaluate the effectiveness and safety of Prochymal® for preventing and treating heart damage resulting from a heart attack. It will study the therapy's ability to improve heart function, limit scar formation and preserve functional heart tissue following a patient's first heart attack. The therapy must be administered within seven days after a patient's first heart attack. In an initial Phase 1 cardiac trial involving 53 patients, adverse events were lower, heart function improved and cardiac arrhythmias (irregular heartbeat) were reduced in patients treated with Prochymal compared to the placebo group.
"Stem cells represent a promising cardiac research avenue, given their potential to restore heart function in at-risk patients," said Howard J. Eisen, M.D., chief of the Division of Cardiology at Drexel University College of Medicine and Hahnemann University Hospital and principal investigator for the Drexel study site. "Cardiologists today are unable to reverse cardiac deterioration following a severe heart attack. If stem cells can effectively prevent or repair heart muscle damage, there is potential to meaningfully reduce long-term complications such as repeat heart attacks and heart failure."
A heart attack occurs when blood flow is suddenly and completely blocked. More than half a million Americans will have their first heart attack this year. According to the American Heart Association, within six years of a recognized heart attack, 18 percent of men and 35 percent of women will have a repeat heart attack. Additionally, a heart attack can significantly weaken heart muscle, which limits the patient's ability to pump blood throughout the body and may ultimately lead to chronic heart failure.
This double-blind, placebo-controlled stem cell study will enroll approximately 220 patients at 40 centers in the United States and Canada.
About Drexel University College of Medicine
Drexel University College of Medicine has established some of the most highly innovative and rigorous academic programs available today, incorporating the University's expertise in engineering and technology into traditional medical training. The College of Medicine is home to one of the nation's leading centers for spinal cord research; one of the foremost centers for malaria study; and a highly regarded HIV/AIDS program with extensive NIH-funded research in prevention and therapeutic interventions. Drexel University College of Medicine has been designated a Vanguard National Center of Excellence in Women's Health by the U.S. Department of Health & Human Services, and is highly respected in numerous other specialties including autism, cardiology, minimally invasive surgery, and toxicology. Visit www.drexelmed.edu for more information.
About Prochymal®
Prochymal® is an investigational therapy developed by Osiris Therapeutics, Inc., containing mesenchymal stem cells from the bone marrow of healthy adult volunteer donors. Studies show that this formulation of mesenchymal stem cells (MSCs) is universally compatible, similar to type O blood. The stem cells found in Prochymal® are delivered intravenously, in combination with standard care. They are designed to provide therapeutic benefit by controlling inflammation, promoting tissue regeneration and preventing scar formation.
In addition to this cardiac research study, Prochymal® has been the subject of Phase III clinical trials for acute and steroid-refractory graft versus host disease and also Crohn's disease, and is the only stem cell therapeutic currently designated by the Food and Drug Administration (FDA) as both an Orphan Drug and Fast Track product. Prochymal® is also being evaluated as a treatment for patients recently diagnosed with type-1 diabetes.