Harvest Technologies Announces Patient Enrollment Has Begun for a Clinical Trial in India Using Autologous Adult Stem Cells to Treat Patients with Non-Reconstructible Critical Limb Ischemia Due to Peripheral Arterial Occlusive Disease

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Harvest Technologies Corp. (http://www.harvesttech.com) announced today that a 60-patient clinical trial using the Company's BMAC(TM) System to treat patients with non-reconstructible Critical Limb Ischemia (CLI) is now underway at Shri Ramachandra Medical Center, a Harvard Medical international-associated institution based in Chennai, India, one of the largest private healthcare facilities in South Asia. The study is being led by principal investigator Prof. K. S. Vijayaragavan, Head of Vascular Surgery at Sri Ramachandra University. Harvest's BMAC System is a point-of-care device for concentrating a patient's own (autologous) bone marrow stem cells in approximately 15 minutes.

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We are particularly excited to participate in this study

    This study is designed to treat patients suffering from advanced thromboangitis obliterans, commonly referred to as Buerger's Disease. This condition is prevalent in India and is caused by smoking, which progressively reduces blood flow to the leg. The initial symptoms are pain in the leg below the knee which, over time, degenerates to a point that the patient may no longer be able to walk. While the underlying cause of Buerger's Disease is different from Peripheral Arterial Occlusive Disease (PAOD) caused by atherosclerosis, which is prevalent in the United States, the treatment for advanced stages of both conditions is bypass surgery or angioplasty. The condition of patients who are being enrolled in this study is so severe that they have exhausted all surgical or endovascular options available and are facing amputation of the affected limb.

Autologous cell therapy has been studied as an innovative treatment option for both cardiac and vascular disease, and based on these studies, it is anticipated that the delivery of a composition of autologous bone marrow cells to the affected limbs of these patients will reduce the possibility of amputation and improve their symptoms. Two small clinical trials have been published that treated these "no option" Buerger's patients with autologous bone marrow cells to treat this patient population. It also is unique in that it compares the relative effectiveness of two different delivery methods. Thirty (30) of the subjects will receive the BMAC composition by injection and thirty (30) will receive the same amount of BMAC but half of the volume by injection and the remaining half by infusion into a major artery.

"We have been very impressed with how easy it has been to harvest, process and deliver these cells all in the same procedure, and the early clinical results have looked extremely promising," said Prof. K. S. Vijayaragavan.

"We are particularly excited to participate in this study," said Gary Tureski, President of Harvest Technologies. "When this study's data are combined with data from our ongoing multi-center FDA study in the U.S., these results will offer us the opportunity to demonstrate the potential for BMAC to be an effective treatment for Critical Limb Ischemia regardless of the underlying cause."

Until now, it has been difficult to process and concentrate a clinically significant dose of adult stem cells from a patient's bone marrow at the point of care. The BMAC System is the world's first and only technique that produces clinically significant amounts of stem and precursor cells from a small aspirate of autologous bone marrow in just 15 minutes. In Harvest's European studies, injected autologous adult stem cell concentrates from bone marrow have shown promise in achieving tissue regeneration in vascular, orthopedic and cardiovascular disease. In the U.S., the BMAC System is currently marketed for use in "...the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of...a cell concentrate from bone marrow."

Harvest Technologies is a privately held company based in Plymouth, Mass.

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Ronald C. Trahan
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