The so-called Phase I study is designed to test the safety of injecting adult stem cells at varying doses in patients who have recently suffered a heart attack.
An estimated 7 million Americans alive today have suffered at least one heart attack and so are at greater risk for chronic heart failure, sudden cardiac death or another, potentially fatal, heart attack.
"This is an important milestone on the journey to better cardiovascular care and to realization of the promise of adult stem cell research," says lead study investigator and cardiologist Joshua Hare, M.D., professor of medicine at The Johns Hopkins University School of Medicine and its Heart Institute.
"Current approaches to cardiovascular disease can prevent heart attack or alleviate its after-effects, but they have not included repair of damage that leaves sizably dead portions of heart tissue as dangerous scars in the heart," says study co-investigator and cardiologist Steven Schulman, M.D., a professor at Hopkins and director of the coronary care unit at The Johns Hopkins Hospital.
Previous research in animals showed that when adult stem cells were injected directly into the heart muscle, heart function was restored to its original condition within two months. Last November, at the American Heart Association Scientific Sessions 2004, the Hopkins team showed, again in animal studies, that more than 75 percent of dead scar tissue disappeared after therapy, which produced mostly healthy, normal-looking heart tissue and left only a small trace of the heart attack.
The Phase I study is being conducted at Hopkins, with support from Baltimore-based Osiris Therapeutics, which developed the stem cell product. The study will involve 48 adu
Contact: David March
Johns Hopkins Medical Institutions