Clinical research trial involves injecting patients' own stem cells into areas of heart with poor blood flow
Columbia University Medical Center and NewYork-Presbyterian Hospital is one of the first medical centers in the country participating in a novel clinical trial investigating if a patient's own stem cells can treat a form of severe coronary artery disease. The Autologous Cellular Therapy CD34-Chronic Myocardial Ischemia (ACT34-CMI) trial is the first 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.
"This promising stem cell therapy may be an alternative for patients without any other means to treat their chest pain," says Warren Sherman, site principal investigator, interventional cardiologist at NewYork-Presbyterian/Columbia and associate professor of medicine at Columbia University College of Physicians and Surgeons.
A Novel Clinical Trial
ACT34-CMI is a prospective, randomized, double-blind, placebo-controlled study that involves adults with CMI who are currently on maximal medical therapy and are not suitable candidates for conventional procedures such as angioplasty, stents or coronary artery bypass surgery. Patients in the study are randomly selected to receive either one of two dosing levels of CD34+ stem cells, or placebo.
The first step in the trial is to establish the baseline frequency and severity of anginal episodes for study participants. Next, all patients receive a series of subcutaneous injections of a commercially produced protein that helps release blood-forming CD34+ cells from bone marrow into the bloodstream. Investigators then use a cell separation system to collect from the bloodstream an enriched preparation of cells containing CD34+ stem cells. When this process is complete, technologists further process the collected stem cells with Baxter's ISOLEX 300i Magnetic Cell Selection System to select the CD34+ stem cells for use in this investigational therapy.
NewYork-Presbyterian's interventional cardiologists then use a catheter-based, non-surgical system to identify ischemic but viable regions of the heart as targets for cell delivery. The researchers then use a special investigational catheter system, developed by Johnson & Johnson, to deliver CD34+ cells, or placebo, into the areas of the heart that have poor blood flow.
The stem cells are thought to work by promoting the growth of new vessels to create pathways to the heart muscle, ensuring adequate nutrition and alleviating the pain associated with the myocardial ischemia.
Researchers are encouraged by reports from the Phase I trial that the therapy appeared to be well-tolerated and no serious adverse events directly related to the stem cell therapy were reported. Through the duration of the 12-month study, there were no deaths or heart attacks. Fifteen of the 18 total Phase I subjects who received the cells reported feeling better with reductions in chest pain and/or improved exercise capacity. Though not sufficiently powered to prove efficacy, these results did lead the way to the initiation of the Phase II ACT34-CMI trial.
The study is sponsored by Cellular Therapies, a business unit of Baxter Healthcare Corp.
Coronary Artery Disease
Coronary artery disease is the most common form of heart disease and the leading cause of death in the United States. The condition occurs when coronary arteries and smaller vessels that supply oxygen-rich blood to the heart become narrowed or blocked by plaque deposits and blood clots.
The American Heart Association estimates that every year between 125,000 and 250,000 individuals with coronary artery disease develop CMI, one of the most severe forms of coronary artery disease, which develops when coronary arteries become so diseased they limit the flow of blood to the heart and send small blood clots downstream, blocking the small blood vessels in the heart.
For more information on the clinical trial, patients may call (866) NYP-NEWS.