Holy Name Medical Center Participates in New Clinical Trial
New cell-based technology in patients with non-reconstructable critical limb ischemia
The Institute for Clinical Research at Holy Name 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. Not only is the condition painful, but it also may result in amputation of the affected limb.
Holy Name Medical Center is the only hospital in northern New Jersey currently participating, and it is one of thirty sites in the United States in this trial. This investigational 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.
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. 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 total.
To qualify, potential candidates must fulfill the following criteria:
Candidates will be evaluated for eligibility. If enrolled, the safety and efficacy of the investigational treatment will be assessed over two years.
- Diagnosed by a physician as having advanced 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.
To learn more about the Harvest CLI clinical trial, contact the Institute for Clinical Research at Holy Name Medical Center, (201) 530-7968. The study website can be found at www.harvestclistudy.com.