Patients' own stem cells may preserve heart muscle function after a heart attack
Clinical trial at the Orlando Health Heart Institute
evaluates the use of stem cells from pelvic bone marrow
to improve heart function.
Newswise — ORLANDO, Fla. (April 11, 2012) --- 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 comprised 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."
For more information on the trial please visit www.neostem.com.
About Orlando Health
Orlando Health is a $1.9 billion not-for-profit health care organization and a community-based network of hospitals and care centers in the Orlando region. The organization, which includes the area's only Level One Trauma Centers for adults and pediatrics, is a statutory teaching hospital system that offers both specialty and community hospitals. They are: Orlando Regional Medical Center; Arnold Palmer Hospital for Children; Winnie Palmer Hospital for Women & Babies; Dr. P. Phillips Hospital; South Seminole Hospital; Health Central, South Lake Hospital (50 percent affiliation); St. Cloud Regional Medical Center (20 percent affiliation) and MD Anderson Cancer Center Orlando – the first affiliate of one of the nation's premier cancer centers, The University of Texas MD Anderson Cancer Center in Houston. Orlando Health's areas of clinical excellence are heart and vascular, cancer care, neurosciences, surgery, pediatric orthopedics and sports medicine, neonatology, and obstetrics and gynecology.
Orlando Health is one of Central Florida's largest employers with nearly 16,000 employees and more than 2,500 affiliated physicians supporting our philosophy of providing high quality care and service that revolves around patients' needs. We prove this everyday with over 110,000 inpatient admissions and nearly 690,000 outpatient visits each year. In all, Orlando Health serves 1.6 million Central Florida residents and nearly 3,000 international patients annually. Additionally, Orlando Health provides approximately $239 million in support of community health needs. More information can be found at www.orlandohealth.com.