Joon Sup Lee, M.D., of the University of Pittsburgh School of Medicine, and McGowan Institute faculty member, is leading a novel clinical trial to study if a patient's own stem cells can treat a form of severe coronary artery disease.
Dr. Lee plans to enroll 10 to 20 subjects in the study, known officially as the Autologous Cellular Therapy CD34-Chronic Myocardial Ischemia (ACT34-CMI) Trial. The ACTC34-CMI trial is the first human Phase II adult stem cell therapy study in the United States designed to investigate the efficacy, tolerability, and safety of blood-derived selected CD34+ stem cells to improve symptoms and clinical outcomes in patients with chronic myocardial ischemia (CMI), a severe form of coronary artery disease.
ACT34-CMI is a prospective, randomized, double-blind, placebo-controlled study that involves adult patients with severe coronary artery disease who are currently on maximal medical therapy and are not suitable candidates for conventional procedures to improve blood flow to the heart, such as angioplasty, stents, or coronary artery bypass surgery.
Dr. Lee's study is one of 15 to 20 research sites nationwide participating in the study, which is sponsored by the Cellular Therapies business unit of the Baxter Healthcare Corporation. Baxter technology is used to select the patient's own CD34+ stem cells that are under investigation in this trial.
Douglas Losordo, M.D., chief of cardiovascular research at Caritas St. Elizabeth's Medical Center in Boston, is the principal investigator of the preceding Phase I trial investigating the injection of autologous CD34+ cells into the hearts of CMI patients. While data from this randomized, multi-center, placebo-controlled, double-blind trial have not been fully analyzed, researchers are encouraged by reports that the therapy appeared to be well-tolerated and no serious adverse events directly related to the stem cell therapy were reported.
According to preliminary anecdotal patient reports, 16 of the 24 total Phase I study subjects reported feeling better with reductions in chest pain and improved exercise capacity during the early stage of the trial. Though not sufficiently powered to demonstrate efficacy, these results led directly to Baxter's decision to sponsor the Phase II trial. Dr. Losordo also is the lead investigator of the Phase II study.
UPMC News Bureau (10/09/06)