Routine stem cell therapies for certain types of heart disease will become a reality in 3-5 years according to Dr. Amit of the University of Pittsburgh Medical Center. All he has to do is succeed in his ongoing clinical trials using cell therapy in congestive heart failure.
The U.S. Food and Drug Administration (FDA) has made Amit the only individual in the entire nation to gain its endorsement to undertake clinical trials for treating heart patients by directly injecting adult stem cells into the heart. Bone marrow is the source of stem cells for the experiment.
The clinical trial for ‘Autologous Bone Marrow Progenitor Cell Treatment for Heart Failure,’ at the University of Pittsburgh Medical Center is lead by Dr. Amit. He is the director of the Center for Cardiac Cell Therapy at the university.
Amit has taken 5 volunteers who would eventually undergo heart transplantation after a few months and injected adult stem cells into the patients’ hearts. As routine as it is to harvest hearts from animals that are under trial, the same is close to reality for humans as well. Removing and studying the hearts that have been injected with adult stem cells a few months prior to transplantation is a possibility.
“This will give an opportunity to evaluate the mechanism of the cells delivered into the human heart,” he noted. “This is the primary endpoint of the study.”
In an earlier study he had shown that “Autologous stem cell transplantation led to significant improvement in cardiac function in patients undergoing off-pump coronary artery bypass grafting for ischemic cardiomyopathy.”
Hearts that were removed 3-6 months after the stem cells were injected showed, “significant angiogenesis,” said Dr. Amit. Four hearts have been removed and examined since the trial started. “We are seeing growth of new blood vessels — angiogenesis,” he said.
So far all FDA approval has been for using adult stem cells for treating heart patients due to the ethical dilemmas surrounding embryonic stem cell research.