The University of Wisconsin School of Medicine and Public Health is among the first medical centers in the country taking part in a clinical trial investigating if a subject’s own stem cells can treat a form of severe coronary artery disease.
The trial, just underway at UW Hospital and Clinics, is enrolling subjects in the Autologous Cellular Therapy CD34-Chronic Myocardial Ischemia (ACT34-CMI) Trial. The first patient underwent the procedure March 7. Because the study is randomized and “double-blinded,” however, neither the patient nor the research physician knows if he received his own stem cells or a placebo substance.
This trial is the first human Phase II adult stem cell therapy study in the U.S. Its goal is to investigate the efficacy, tolerability, and safety of blood-derived selected stem cells to improve symptoms and clinical outcomes in patients with chronic myocardial ischemia (CMI), a severe form of coronary artery disease.
Myocardial ischemia, which affects hundreds of thousands of people, is a serious heart condition that involves narrowing of coronary arteries and results in limited blood flow to the heart. A person who suffers from chronic myocardial ischemia continues to experience insufficient flow of oxygen-rich blood to the heart despite optimum medical intervention.
“This type of therapy--regenerative medicine--treats diseases by using growth factors, genes or stem cells to promote blood vessel or tissue growth,” explains Amish Raval, MD, head of cardiovascular regenerative medicine at UW Health. The goal with this approach, he says, is to promote either angiogenesis, which is the growth of new capillaries; arteriogenesis, or the maturation and enlargement of existing arteries and arterioles; or vasculogenesis, the sprouting of new arteries and arterioles.
The stem-cell study is considered the gold standard of research design: a prospective, randomized, double-blind, placebo-controlled study that involves adult subjects who have severe coronary artery disease, are currently on maximal medical therapy and are not suitable candidates for conventional to improve blood flow to the heart.
UW Hospital and Clinics is one of 15 to 20 research sites nationwide participating in the study, which is sponsored by the Cellular Therapies business unit of Baxter Healthcare Corporation. Baxter technology is used to select the subject’s own CD34+ stem cells that are under investigation in this trial.