Posted: Dec 5, 2012 1:02 PM by Press Release
NEW ORLEANS - Ochsner Medical Center is participating in a breakthrough, randomized clinical trial which evaluates the effectiveness of a new cell-based technology in patients with non-reconstructable critical limb ischemia (CLI). CLI, a severe condition of peripheral artery disease (PAD), is a blockage of the arteries which decreases blood flow to the legs and feet to the point of severe pain at rest or skin ulcer formation.
Ochsner is one of 22 sites in the United States currently participating, and is the only location to offer this trial in the greater Gulf South region.
This approach, called 'bone marrow aspirate concentrate' (BMAC), uses a patient's own cells, including stem cells harvested from their bone marrow to stimulate growth of new blood vessels in the lower extremities. These patients with CLI have no surgical or catheter-based option ('no option critical limb ischemia' NO-CLI). A unique aspect of this stem cell-based treatment is that this procedure allows both the cell harvest and implantation to be carried out in one procedure under local anesthesia with sedation.
"The Gulf South region of the United States has a very high proportion of patients with peripheral arterial disease, compared to other areas in the United States," said Hernan A. Bazan, MD, FACS, Vascular/Endovascular Surgeon, John Ochsner Heart & Vascular Institute and principal investigator for the study. "The challenge in this region is that there is also a higher level of amputations which are being performed, compared to other areas of the country. Many opportunities exist to improve upon this. This type of technology will allow us to offer select patients with non-healing ulcers who cannot undergo a leg bypass or angioplasty or stent treatments a possible other mode of treatment. In future years, many of us think this type of cellular-based technology will be part of our armamentarium in the treatment of severe peripheral arterial disease/critical limb ischemia."
A patient's bone marrow is harvested from his pelvis. Then a centrifuge-type machine, the size of a desktop computer, concentrates the marrow cells. Doctors inject the cell concentrate into the leg that has poor circulation. The procedure is performed under local anesthesia with sedation. There, the cells may respond to the low-oxygen environment and help build new vessels, improving blood flow. With increased blood flow in the extremity, ulcers may be able to heal.
Patients accepted into the study will have a 66% chance of being randomized to receive their own bone marrow concentrate (stem cell) and a 33% chance of being randomized to receive placebo. Since this is a randomized study, all patients will have bone marrow samples drawn, so neither they nor the investigators can tell which they received.
The study will enroll approximately 210 patients across several U.S. medical centers. To qualify, potential candidates must have the following characteristics:
· Diagnosed by a physician as having advance Peripheral Arterial Disease (PAD) or Critical Limb Ischemia (CLI).
· Have gangrene, an ulcer, or sore of the foot or leg.
· No longer be a candidate for surgical treatment or any other invasive procedure (i.e. angioplasty or bypass surgery) and have exhausted all viable options.
· Not receiving dialysis treatment.
Medicare has approved participation in the U.S. Food and Drug Administration trial. Those with private insurance also may be eligible. Candidates will be evaluated for eligibility. If enrolled, the safety and efficacy of the treatment will be assessed over two years. To learn more about the Harvest CLI clinical trial, contact Clinical Research Coordinator Shannon Williams (RT) at: (504) 842-6487 or firstname.lastname@example.org.