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Cutting Edge

Title
Research to save limbs from amputation
Date
01/22/2014
Article

The CAMC Clinical Trials 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, or CLI. Dr. Ali AbuRahma is the lead physician on the study with Drs. John Campbell, Patrick Stone; Shadi AbuHalimah, Arun Nagarajan, Ahmed Khalid, Mark Bates and Aravinda Nanjundappa also participating in the study.

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.

CAMC Clinical Trials Center is one of 30 sites in the United States currently participating.

This investigational approach, called "bone marrow aspirate concentrate," 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. 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 percent chance of being randomized to receive their own bone marrow concentrate (stem cell) and a 33 percent 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 total patients.

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.

Candidates will be evaluated for eligibility. If enrolled, the safety and efficacy of the investigational treatment will be assessed over two years.

To learn more about the Harvest CLI clinical trial, contact the CAMC Clinical Trials Center at

(304) 388-9944 or the study website can be found at www.harvestclistudy.com.

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