Harvest Technologies Corp. completed enrollment in a clinical trial of its technique to use concentrated autologous bone marrow cells to treat patients with non-reconstructable critical limb ischemia.
Harvest said 48 patients in the U.S. and India signed on for the trial of 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. Preliminary data should be available by the end of February, according to a press release.
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. The Harvest study examined whether patients’ stem cells can help treat the condition, with 32 patients receiving BMAC injections and 16 receiving placebo injections. A similar study of 60 patients in India with another form of CLI, thromboangitis obliterans or Buergers’s disease, showed an amputation rate of only 10 percent, statistically significant improvement in reduction of pain, perfusion measures and quality of life, according to the press release.
Thromboangitis obliterans is the recurring inflammation and clotting of small and medium arteries and veins in the hands and feet, often associated with smoking or with the use of smokeless tobacco.
Harvest won Food & Drug Administration approval for another trial last month. The FDA’s investigational device exemption allows the company to study whether its BMAC system can help re-grow dead or damaged heart tissue. The two-phase feasibility trial will see one patient group injected with the concentrated stem cells after CABG surgery and a control group treated with CABG alone.