Harvest Technologies Corp. released positive results from a clinical trial in India of its technique to use concentrated autologous bone marrow cells to treat patients with non-reconstructable critical limb ischemia.
The Plymouth, Mass.-based company said the 60-patient trial examined its Bone Marrow Aspiration Concentrate system, which is designed to concentrate patients’ own bone marrow stem cells in approximately 15 minutes in the operating room. The study compared the relative effectiveness of injecting all of the bone marrow concentrate and injecting half of the volume and infusing the remainder into a major artery.
The data showed that 90 percent of patients treated with the BMAC product survived 12 weeks amputation-free. Subjects showed significant reduction in pain perception, could walk further and with less pain and showed improved perfusion measures.
Critical limb ischemia is a severe obstruction of the arteries in the arms or legs that blocks blood flow to the extremities and has progressed to the point of severe pain, skin ulcers or sores. A variant called thromboangitis obliterans, or Buergers’s disease, is the recurring inflammation and clotting of small and medium arteries and veins in the hands and feet, often associated with the tobacco use.
CLI is measured using the Rutherford system, which classifies its severity according to a scale of one to six, with six being the most serious condition of imminent amputation. The study showed that patients treated with BMAC showed a mean reduction of one Rutherford class (all 60 patients were Rutherford class four or five at the onset of the trial).
It’s the latest round of clinical study news for Harvest Technologies, which completed enrollment in another CLI study earlier this month and won an investigational device exemption from the Food & Drug Administration to conduct a clinical trial of its technique to use concentrated autologous bone marrow cells to treat patients undergoing coronary artery bypass grafts.