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OHSU Evaluating Stem Cell Therapy for Heart Attack Damage

January 6, 2010

The Oregon Health & Science University (OHSU) announced that it is recruiting patients that have had a heart attack in a clinical trial using adult stem cells. The stem cells being used come from the biotechnology company Osiris Therapeutics. They are made from the bone marrow of healthy volunteers and expanded in tissue culture. The drug name of these stem cells is Prochymal, and has been used in clinical trials of other conditions such as Graft versus Host Disease, Chronic Obstructive Pulmonary Disease, and more recently in patients with autoimmune type 1 diabetes. One of the interesting properties of Prochymal is that the stem cells do not require matching with the recipient and are called "universal donor" cells.

OHSU is the only place in the Northwest where patients can participate in this clinical trial, being one of only 40 sites in the world in which this treatment is being offered on an experimental basis. The question that the trial is trying to answer is whether stem cell therapy be administered by intravenous injection and prevent loss of heart muscle, called myocardium, after a heart attack. Additionally, the study is seeking to determine whether the stem cells actually can help cause the creation of new heart muscle.

"Stem cells are a promising method for regenerating heart muscle, limiting the formation of scar tissue and restoring heart function," says interventional cardiologist Saurabh Gupta, M.D., the director of the cardiac cath lab at OHSU and principal investigator for this trial. "The challenge is finding the best way to deliver the stem cells."

The advantage of intravenous administration of stem cells is that it alleviates the need for complex medical equipment used by others performing clinical trials of stem cells. For example, some investigators use a needle-like device to physically inject the heart muscle with stem cells. Although this is a promising approach, the device, called NOGA, is very expensive and requires a high degree of user experience.

One of the underlying theories behind this clinical trial is that the signals sent out by the damaged heart tissue actually "call in" the stem cells that have been injected intravenously, and therefore circulate throughout the body.

"Our current understanding is that the swelling sends out signals that serve as homing devices to the stem cells," Gupta says. "That's why the trial excludes patients with ongoing infections or advanced lung disease."

The clinical trial requires that patients come to the center for several follow-up visits, and the length of the trial is 2-years. Patients interested in the clinical trial will have to undergo several evaluations as part of the screening process, which are performed at no cost to the patient. Patients or families interested in this clinical trial are advised to contact 503-494-8750. For more information about Prochymal, the investigational product used in the trial, one may go to the Osiris Therapeutics website.



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