Cardiologist Sanjay K. Gandhi, M.D., FACC, who is leading the study at Wake Forest Baptist’s Heart Center, said that a smaller, earlier study of these bone marrow derived stem cells, or mesenchymal stem cells, found they were safe for patients and may have the ability to limit scar formation, improve heart function and preserve tissue following a first heart attack.
“The earlier phase of the study showed that these mesenchymal stem cells (Prochymal®) could target the damaged myocardial tissue and could initiate a process for recovery of heart muscle and hopefully improvement of the overall heart,” Gandhi said.
The criteria for patients to participate in the study are very strict, Gandhi said. “It has to be their first heart attack. They must have undergone angioplasty, have substantial damage to their heart muscle, and have an ejection fraction less than 45 percent. And, they must receive the stem cell therapy within seven days of their heart attack.”
The adult mesenchymal stem cells are derived from donor bone marrow and put in a liquid suspension prepared in advance by Osiris Therapeutics Inc., which is sponsoring the study. That liquid is infused intravenously and finds its way to the heart muscle.
The infusion takes about 45 minutes. “They will undergo intravenous infusion of either the mesenchymal stem cells or a placebo in the cath lab where they are monitored,” Gandhi said.
Study participants get a baseline echocardiogram (echo) and cardiac magnetic resonance imaging (MRI) and then receive follow-up MRIs every three months to measure their heart function.
Many heart attack patients suffer heart muscle damage even if they are treated with medications and stented immediately.
“Stem cells represent a promising cardiac research avenue,” Gandhi said. “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.”
Wake Forest Baptist is one of 41 locations in the country and the only one in a five-state region participating in the study, which is titled “Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI).”
Participants do not have to be Wake Forest Baptist patients, but they do have to meet the criteria. For more information about the study, contact 336-713-4432.