Stem cells from the pelvic bone may help hearts beat stronger. Doctors and other clinicians at the Orlando Health Heart Institute are researching the use of stem cells from pelvic bone marrow to restore tissue and improve heart function after muscle damage from heart attacks.
"The thought is the body may use itself to heal itself," said Vijaykumar S. Kasi, MD, PhD, an interventional cardiologist, director, Cardiovascular Research, and principal investigator for the clinical trial at ORMC. "Because stem cells are immature cells they have the potential to develop into new blood vessels and preserve cardiac muscle cells. By infusing certain stem cells into the area of the heart muscle that has been damaged from a heart attack, tissue can be preserved and heart function restored."
The PreSERVE-AMI Study, sponsored by Amorcyte, LLC, a NeoStem, Inc. company (NYSE Amex: NBS), is for patients who have received a stent to open the blocked artery after a specific heart attack history (in part a ST-Segment Elevation Myocardial Infarction, or STEMI, a critical type of heart attack caused by a prolonged period of blocked blood supply, affecting a large area of the heart muscle and causing changes in the blood levels of key chemical markers). The study evaluates the effectiveness and safety of infusing stem cells collected from a patient's bone marrow into the artery in the heart that may have caused the heart attack. About 160 patients will participate in this national study at approximately 34 sites.
The infusion procedure begins with a catheter inserted through an incision in the groin. An X-ray camera is used to guide doctors in positioning the catheter in the heart artery where the stent was placed. A balloon is inflated within the stent and the infusion takes place in the area impacted by the heart attack. Because the study is randomized, double blinded and placebo controlled, patients are infused with either AMR-001, a cell therapy product composed of stem cells taken from one's own bone marrow, or a placebo (inactive substance).
Prior to the infusion, patients are screened using various assessments including an electrocardiogram, a cardiac MRI (magnetic resonance image) and a cardiac nuclear test. After the necessary screenings, patients have a mini-bone marrow procedure where the stem cells are "harvested" (removed) from the bone marrow in their pelvic bone, using a special needle. The stem cells are processed at Progenitor Cell Therapy, another NeoStem, Inc. company, in preparation for infusion. Patients who are randomized to placebo will have their bone marrow frozen and stored and available to them for clinical use, should they require bone marrow for any reason.
"We are excited to participate in innovative clinical trials as part of our continued efforts to play a vital role in future solutions to improve patient outcomes," said Dr. Kasi. "Heart disease remains the No.1 killer of men and women in our country." Effective treatment options are part of the medical journey to more heart healthy communities locally and globally.
"Severe heart failure, often the end result of large or multiple heart attacks, is a major health care challenge, impacting more than five million people in the United States and costing more than $35 billion annually," said Dr. Kasi. "Stem cell therapy is part of the movement from treatment to cure and has the potential to overcome limitations and expenses of heart transplants and offers hope for patients who are desperately praying for another chance at life."
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