FDA Green Lights Harvest’s Stem Cell Trial

Harvest Technologies, a Plymouth, MA, company that uses stem cells from bone marrow to treat critical limb ischemia, received the go-ahead yesterday from FDA to start a 48-patient trial for the company’s Bone Marrow Aspirate Concentrate (BMAC) System. If all goes as planned, Harvest expects the device to hit the market sometime in 2010.

The BMAC System concentrates a patient’s bone-marrow stem cells in approximately 15 minutes, then injects them into the affected limb to reduce the likelihood of amputation. Critical limb ischemia is a late-stage form of Peripheral Arterial Disease, which involves clogged arteries — commonly in the legs — that can result in toe or feet amputation. The thinking behind the BMAC device is that the injection of stem cells will arrest and possibly reverse the effects of critical limb ischemia.

In a European pilot study of BMAC, 23 patients with ischemic legs who were threatened by amputation were injected with their own bone-marrow stem cells; 16 (70 percent) were able to avoid amputation.

Following yesterday’s IDE approval, Harvest Technologies’ president, Gary Tureski, told The Patriot Ledger that BMAC’s ability to quickly identify and concentrate stem cells that aid in the creation of new blood vessels is what makes it superior to other technologies that use bone-marrow stem cells in a similar way. Harvest’s device is unique, according to Tureski, because a doctor can complete the whole process in one sitting, while other systems rely on shipping the bone marrow off-site for the concentration process, requiring a patient to make more than one trip to the doctor’s office.

“We do it right at the bedside, right at the point of care,’’ Tureski told the paper. ‘‘The whole procedure can be done in less than an hour.’’

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