Camden, New Jersey (PRWEB) June 12, 2013
Our Lady of Lourdes Medical Center and The Heart House are participating in a clinical study to determine whether a patient’s own (autologous), adult, stem cells are safe and can relieve chronic chest pain caused by coronary artery disease, as well as increase their ability to walk/exercise.
The RENEW study, sponsored by Baxter Healthcare Corporation and endorsed by the FDA to support a Biologic License Application for investigational CD34+ cell therapy, is a Phase III clinical trial to test the safety and efficacy of CD34+ stem cells. The study is being conducted at only 50 sites in North America and will involve approximately 440 patients.
The Principal Investigator, Vijay Verma, MD, FACC, and Sub-Investigator Andrew Zinn, MD, both interventional cardiologists with Cardiovascular Associates of the Delaware Valley (The Heart House), performed the first procedure at Our Lady of Lourdes Medical Center on April 25, 2013. The patient suffers from severe refractory angina, with two of the three arteries that supply oxygen to the heart completely blocked and is unable to undergo conventional revascularization.
“The patient suffers chest pain every day due to the blockages,” said Dr. Verma. “She has exhausted all other optimal therapies, including angioplasty, bypass surgery and enhanced external counter pulsation (EECP) to relieve the persistent chest pain.”
Patients enrolled in the study are randomly assigned to undergo the procedure or receive the standard of care. Patients in the procedure group are blindly randomized to receive either the stem cells or a placebo.
Forty-eight hours prior to the procedure, Dr. Verma conducted Apheresis procedure to selectively withdraw cells from the patient’s bloodstream. These cells were sent to a special lab where CD34+ cells were extracted and sent back to the hospital for injection into the patient’s heart. Derived from bone marrow, CD34+ cells are comprised of endothelial progenitor cells, which may be able to regenerate heart tissue and develop into new blood vessels. Previous Phase I & Phase II clinical trials have shown that the administration of the CD34+ cells were safe, and a reduction in chest pain and increased ability to exercise was noted in people with myocardial ischemia, or lack of oxygen flow to the heart tissue.
During the nearly four-hour procedure, Dr. Verma and his team created an electrical map of the patient’s heart to locate the damaged area they believed might be causing the chest pain. Using a catheter threaded through the patient’s groin area to the heart, Dr. Verma injected the patient’s CD34+ stem cells into areas of heart muscle with poor blood circulation. Neither Dr. Verma nor the patient knows if the stem cells or a placebo were injected until after the trial is completed and data has been obtained and evaluated.
“We will follow her for the next two years to see whether the injections improve her chest pain and her tolerance to exercise,” said Dr. Verma.
To learn if you are eligible to participate in the study, visit http://www.renewstudy.com.