Baptist Memorial Health Care-Memphis has begun its first clinical study involving a stem cell treatment for heart attacks.

Dr. Frank A. McGrew III at Stern Cardiovascular Center PA is identifying patients who meet the criteria for the study and then assessing the effectiveness of the therapy in healing scarred cardiac tissue. The study is the first in the Mid-South to incorporate stem cells for the treatment of cardiovascular disease, McGrew said.

“This is just one of many different ways we’re trying to improve heart muscle function once it has been stressed by an artery blockage or a heart attack,” McGrew said.

Baptist is one of 41 hospitals throughout the United States taking part in a Phase II clinical study of Prochymal, a product derived from adult bone marrow and patented to Osiris Therapeutic Inc. The study will involve 220 patients nationwide.

First one

Baptist began screening heart attack patients in late September to determine who might benefit from the study. So far, one patient has received the treatment – Steven Cochran, a 47-year-old Cordova resident who began experiencing chest pains Oct. 10 while jogging.

The half-mile, nighttime trek back to his home was the longest walk of his life, he said.

“I’m lucky it wasn’t a more severe heart attack and I didn’t fall out,” Cochran said. “I don’t know if anybody would have noticed.”

Cochran underwent angioplasties and a stent procedure. He did not require bypass surgery. Six days after suffering the heart attack, he received the stem cells through an IV infusion. McGrew, the primary research investigator for the trial in Memphis, told Cochran he was a good candidate for the procedure.

“I work at Wright Medical,” Cochran said. “Our company’s success is due to clinical trials. For me, it was a natural choice to volunteer to be a patient in a clinical trial.”

So far, he said he feels great and will return to work Monday.

“I had no pain, no side effects, nothing,” he said.

For the next two years, Cochran will be assessed regularly to ensure scar tissue in his heart has healed.

The study is limited to people between the ages of 21 and 85 who have had their first heart attack. The therapy must be administered within seven days of the heart attack.

“The stem cells are injected in a peripheral vein,” McGrew said. “They migrate through the circulatory system and go to the area of injury, which in this case is the heart. The body probably has this kind of response anyway whenever there is injury, but the number of stem cells that leave the bone marrow and … move to the heart are probably so small that they don’t have any significant influence on how the heart heals.”

The bone marrow used in the product is taken from adult donors.

“One of the advantages is these donors are young adults so the stem cells are young,” McGrew said. “Some investigators think that might make a difference in how people respond.”

Potential benefits

Paula Higdon, the clinical research coordinator for the Baptist Clinical Research Center, said she’s excited to be involved with the study because her background is in cardiovascular nursing.

An echocardiogram, a cardiac MRI and other tests are performed to determine who might meet the study criteria. The tests are repeated at three-month and six-month periods to measure effectiveness. Follow-up tests also occur.

“Usually, we can get all those things done in a day’s time so it’s not very time-consuming,” Higdon said.

However, the hospital is being very selective about who qualifies.

“The guidelines and the criteria for this study are very specific, because they want a certain type of patient – one that is fairly healthy,” she said. “So it’s going to be hard to find people who meet those specific criteria.”

If clinical trials determine the therapy to be safe and effective, many people could benefit.

“The heart attack cases with no scar tissue and no damage are a very, very low number,” Higdon said. “What a heart attack is is when you actually have a lack of blood flow to an area of tissue. When you have lack of blood flow, that tissue is going to die or there is going to be inflammation there. It reduces the effectiveness of that muscle. Scar tissue doesn’t contract.”

Other possibilities

Osiris Therapeutics is based in Columbia, Md. The company is working to commercialize products derived from adult bone marrow. The technology is based on the work of Dr. Arnold Caplan at Case Western Reserve University in Cleveland.

Besides the Phase II clinical trial with Prochymal for heart attacks, the same product is being tested in Phase III clinical trials for potential treatments of other diseases. The Phase III clinical trials of Prochymal are for Graft versus Host Disease and Crohn’s disease.

Other Phase II clinical trials involve diabetes and chronic obstructive pulmonary disease.

The therapy has the potential to treat a variety of diseases because the stem cells follow inflammatory signals that send them to various areas of the body to aid in repair, according to information posted on Osiris Therapeutics’ Web site, www.osiristx.com.

McGrew said he also has made inquiries about another clinical trial that would use stem cells to treat people with chronic heart disease. This therapy was developed by Florida-based Bioheart Inc. It uses stem cells produced by the person receiving the therapy, he said.

“There are two different general areas of stem cell use for heart attacks,” McGrew said. “One is for chronic artery blockage and the other is for people with a recent heart attack, which is what this situation (Osiris Therapeutics’ Prochymal) is and this study involves. We have another study that we’re hoping to commence that will use a different type of stem cell for patients with chronic heart disease and heart muscle weakness.”