Researchers at UCSF Medical Center started enrolling patients in an early-stage adult stem cell therapy, developed by Osiris Therapeutics Inc., for first-time heart attack patients.
The two-year Phase II trial ? the first stem cell clinical trial in cardiology at the University of California, San Francisco ? will use mesenchymal stem cells obtained from the bone marrow of health adult donors. It is designed to combat symptoms related to heart damage that continue to develop following a heart attack, including low pumping capacity, inflammation and increased scar tissue.
UCSF will enroll 10 patients in the trial. Overall, about 220 patients will be enrolled nationally.
Those follow-on factors are believed to increase the risk of another heart attack. According to the American Heart Association, more than 500,000 Americans will experience their first heart attack in 2009 and 18 percent of men and 35 percent of women will have another heart attack within six years.
The exact mechanisms of the stem cells? actions in this setting are not yet known, UCSF said, but previous studies suggest that they could reduce the amount of scar tissue and inflammation caused by heart attacks.
?Many of us have been working for a long time to have a therapy for patients that could improve organ damage at the basic level,? Dr. Yerem Yeghiazarians, codirector of the Adult Cardiac Catheterization Laboratory and director of the UCSF Translational Cardiac Stem Cell Program said in a press release.
Yeghiazarians is the lead investigator of the study.
All patients arriving at UCSF?s emergency department with a heart attack will continue to be treated with standard measures, the university said. Some patients, however, will receive the stem cell therapy within seven days of their attack. Those patients will have a baseline ejection fraction ? the measurement of blood pumped out of the ventricles per heart beat ? of 30 percent to 45 percent.
The one-time, IV infusion of Osiris? Prochymal stem cell therapy at UCSF takes about a half-hour. Patients will be followed for two years.
Osiris, based in Columbia, Md., in February announced safety data from a Phase I trial of Prochymal. That study did not include UCSF.
The two-year Phase II trial ? the first stem cell clinical trial in cardiology at the University of California, San Francisco ? will use mesenchymal stem cells obtained from the bone marrow of health adult donors. It is designed to combat symptoms related to heart damage that continue to develop following a heart attack, including low pumping capacity, inflammation and increased scar tissue.
UCSF will enroll 10 patients in the trial. Overall, about 220 patients will be enrolled nationally.
Those follow-on factors are believed to increase the risk of another heart attack. According to the American Heart Association, more than 500,000 Americans will experience their first heart attack in 2009 and 18 percent of men and 35 percent of women will have another heart attack within six years.
The exact mechanisms of the stem cells? actions in this setting are not yet known, UCSF said, but previous studies suggest that they could reduce the amount of scar tissue and inflammation caused by heart attacks.
?Many of us have been working for a long time to have a therapy for patients that could improve organ damage at the basic level,? Dr. Yerem Yeghiazarians, codirector of the Adult Cardiac Catheterization Laboratory and director of the UCSF Translational Cardiac Stem Cell Program said in a press release.
Yeghiazarians is the lead investigator of the study.
All patients arriving at UCSF?s emergency department with a heart attack will continue to be treated with standard measures, the university said. Some patients, however, will receive the stem cell therapy within seven days of their attack. Those patients will have a baseline ejection fraction ? the measurement of blood pumped out of the ventricles per heart beat ? of 30 percent to 45 percent.
The one-time, IV infusion of Osiris? Prochymal stem cell therapy at UCSF takes about a half-hour. Patients will be followed for two years.
Osiris, based in Columbia, Md., in February announced safety data from a Phase I trial of Prochymal. That study did not include UCSF.