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, 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
Source:University of Wisconsin-Madison