Restoring heart muscle function with pelvic bone stem cells

Researchers from the Orlando Health Heart Institute are exploring how to restore tissue and improve heart function after muscle damage from heart attacks with stem cells from pelvic bone marrow, as it may improve the heartbeat. The ORMC's leading researcher for the clinical trial, Vijaykumar S. Kasi, MD, PhD, an interventional cardiologist, director, Cardiovascular Research, explains: "The thought is the body may use itself to heal itself. 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 assesses the efficacy and safety of infusing stem cells obtained from a patient's bone marrow into the artery in the heart, which may have caused the heart attack in patients who received a stent to open the blocked artery after a specific heart attack history, such as STEMI. A ST-Segment Elevation Myocardial Infarction (STEMI) is a critical type of heart attack that occurs due to the blood supply to the heart being blocked for a prolonged period of time, which affects a large area of the heart muscle and causes changes in the blood levels of key chemical markers. The national, randomized, double blinded and placebo controlled study will involve approximately 160 patients, at about 34 sites, to evaluate the efficacy and safety of infusing stem cells obtained from a patient's bone marrow into the artery in the heart that may have caused the heart attack. The surgeons will first insert a catheter into an incision in the patient's groin. Guided by an x-ray camera, the doctors will then position the catheter in the location of the heart artery where the stent was placed, before inflating a balloon within the stent and infusing either AMR-001, a cell therapy product comprised of stem cells taken from the patient's own bone marrow, or a placebo into the affected area. Before the infusion is made, the patients undergo various tests, including an electrocardiogram, a cardiac MRI and a cardiac nuclear test. After the patient has received all screenings required, the doctors will perform a mini-bone marrow procedure, in which they remove stem cells from the bone marrow of the patient's pelvic bone with a special needle. The stem cells are subsequently processed in preparation for infusion. The bone marrow of patients randomized to receive placebo will be frozen and stored in case they require bone marrow for any reason. Dr. Kasi announces: "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. Heart disease remains the No.1 killer of men and women in our country." Finding effective treatment approaches is one step towards achieving more heart healthy communities worldwide. Kasi concludes: "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. 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."