The study will determine whether stem cell therapy holds promise for people with severe coronary artery disease and congestive heart failure not amenable to standard therapies, according to Vincent Pompili, MD, Director of Interventional Cardiology at UHC and the study's principal investigator. If the approach proves successful in mice, Dr. Pompili says, clinical trials in human subjects could begin within 18 months. Dr. Pompili is also associate professor of medicine at Case Western Reserve University.
An estimated 5 million Americans have congestive heart failure, a condition that disables the heart muscle and causes the heart to pump inefficiently. About half of all heart failure patients die within five years of their diagnosis, reports the Heart Failure Society of America.
The stem cell treatment, called "therapeutic angiogenesis," is designed to grow new blood vessels in damaged heart muscle by infusing stem cells from the cord blood. Stem cells--immature cells that develop into mature red blood cells, platelets or white blood cells--have proved to be an effective arsenal for other fatal diseases.
"For years, we have successfully treated young leukemia patients with cord blood stem cells," says Mary J. Laughlin, MD, Director of Allogeneic Bone Marrow Transplantation at UHC and co-investigator. Dr. Laughlin, assistant professor of medicine at CWRU, is the nation's leading expert in the use of cord blood to restore the blood-making ability of bone marrow damaged by high doses of chemotherapy. "Our new study is an ambitious attempt to find out whether this same treatment can benefit an entirely different group of patients," she says.
Angiogenesis--the growth of new blood vessels--does not normally occur in the human heart.. But heart disease researchers view angiogenesis as a potentially life-saving process in areas of the heart that lack sufficient blood flow. Studies using human growth factors (such as the gene therapy injection of a protein called VEGF) have attempted angiogenesis as an alternative to coronary bypass surgery. So far, those results have not been entirely successful.
Cord blood stem cells, harvested from the placenta after a baby is born and with parental consent, are not to be confused with embryonic stem cells. The national debate over the ethical issues of harvesting stem cells from embryos does not apply to stem cells retrieved from tissue that is normally discarded.
If pre-clinical trials with mice prove successful--and these stem cells grow new blood vessels in heart muscle, Dr. Pompili says, clinical trials will begin for people with heart failure.
First, however, researchers will obtain the stem cells from the patient's own bone marrow, inject them into the damaged heart, and look for blood vessel growth. By using the patient's own bone marrow, there is no chance of the patient's immune system rejecting the injected stem cells.
University Hospitals Health System (UHHS) is the region's premier healthcare delivery system, serving patients at more than 150 locations throughout northern Ohio.
The System's 947-bed, tertiary medical center, University Hospitals of Cleveland (UHC), is the primary affiliate of Case Western Reserve University. Together, they form the largest center for biomedical research in the State of Ohio. The System provides the major clinical base for translational researchers at The Research Institute of University Hospitals of Cleveland, as well as a broad and well-characterized patient population for clinical trials involving the most advanced treatments. Included in UHC are Rainbow Babies & Children's Hospital, among the nation's best children's hospitals; Ireland Cancer Center, northern Ohio's only National Cancer Institute-designated Comprehensive Cancer Center (the nation's highest designation); and MacDonald Women's Hospital, Ohio's only hospital for women.
Committed to advanced care and advanced caring, University Hospitals Health System offers the region's largest network of primary care physicians, outpatient centers and hospitals. The System also includes a network of specialty care physicians, skilled nursing, elder health, rehabilitation and home care services, managed care and insurance programs, and the most comprehensive behavioral health services in the region.