Autologous Stem Cells May Repair Damaged Hearts

The autologous cellular therapy CD34-Chronic Myocardial Ischemia (ACT34-CMI) trial is a randomized, double-blind, placebo-controlled phase II study that involves adult subjects with severe coronary artery disease who are currently on the maximum medical therapy, and who are not suitable candidates for conventional procedures to improve blood flow to the heart such as angioplasty, stents, or coronary artery bypass graft (CABG) surgery.

The researchers used a cell separation system to collect an enriched preparation of cells from the subject's own bloodstream containing CD34+ stem cells. When this process--known as apheresis--was complete, technologists further processed the collected stem cells to select the subject's CD34+ stem cells. The researchers then used a catheter-based, non-surgical system to map the patient's heart three-dimensionally to identify the damaged areas into which the stem cells would be injected. They then used a special investigational catheter to precisely deliver either one of two dosing levels of CD34+ stem cells, or placebo, into the areas of the heart that have been identified as having poor blood flow. 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. A follow-up examination is planned at 12 months.

"What we're hoping is that these stem cells will be able to stimulate the growth of new blood vessels to bring more blood and oxygen to the heart muscle, so that these patients will have a better quality of life and less chest pain,” said Dr. Gary Schaer, director of the cardiac catheterization lab at Rush University Medical Center (Chicago, IL, USA), one of 15 to 20 research sites throughout the United States participating in the study.

The study is sponsored by the cellular therapies business unit of Baxter Healthcare Corporation (Deerfield, IL, USA), manufacturer of the Isolex 300i magnetic cell selection system used to separate the subject's own stem cells.


Related Links:
Rush University Medical Center
Baxter Healthcare Corporation