Harvest Technologies, Inc.: French and U.S. Physicians Say a Simple, Point-of-Care System for Concentrating Autologous Adult Stem Cells From Bone Marrow Is Enabling European Clinicians to Offer New Therapies for a Variety of Serious Diseases, With No Repo
French and U.S. Physicians Say a Simple, Point-of-Care System for Concentrating Autologous Adult Stem Cells From Bone Marrow Is Enabling European Clinicians to Offer New Therapies for a Variety of Serious Diseases, With No Reported Side EffectsData Presented at Harvest Technologies-Sponsored
Symposium: “The Potential for Concentrated Bone Marrow Stem Cells in Orthopedic Surgery: The European Experience” PLYMOUTH, MA — (MARKET WIRE) — November 16, 2006 — Harvest Technologies Corp.(www.harvesttech.com) announced today that a French and a U.S. physiciantold an audience of other physicians, medical industry executives andpatients about a simple, point-of-care device for concentrating autologousadult stem cells from bone marrow that is enabling European clinicians tooffer stem cell therapies for orthopedic and other diseases, with noreported side effects.
Phillipe Hernigou, M.D. (Henri Mondor Hospital, Creteil, France) andSherwin Kevy, M.D. (Associate Professor of Pediatrics, Harvard MedicalSchool, and Director of the Transfusion Services Emeritus at Children’sHospital (Boston) and an Investigator at CBR Institute for BiomedicalResearch (Boston) presented data related to the clinical experiences inEurope using Harvest’s BMAC System. “Harvest’s technology is an importantadvance for medicine because it can process and concentrate cellularcomponents, including the adult stem cells, from autologous bone marrow notonly at the point-of-care, but also in just 15 minutes,” said Dr. Hernigou.”And, the concentrate produced by the BMAC System has been documented to besignificantly easier to implement and requires one-third-less bone marrowaspirate from the patient compared to concentrations obtained by usingother, laborious laboratory methods used in successful clinical studies,”added Dr. Kevy. He also noted that there are 20 published clinical studiesinvolving 1,483 patients at 36 sites around the world demonstrating thatthis approach (concentrating adult stem cells derived from autologous bonemarrow) enables clinicians to offer new therapies for a variety of seriousdiseases, with no reported adverse events.
The BMAC™ System is currently being used in Europe to treat vascular,orthopedic and cardiovascular diseases. It is the world’s first and onlyproduct that makes possible the use of a clinically effective quantity ofcellular compositions from a small aspirate of autologous bone marrow,including a large quantity of adult stem cells, derived from a patient atthe point-of-care, in just 15 minutes. It is well-established in thescientific literature that a concentrate of autologous adult stem cellsfrom bone marrow is clinically effective in achieving tissue regenerationin cardiovascular, orthopedic and vascular diseases. A concentrate of thesecells contains “not only stem cells and precursor cells as a source ofregeneration tissue, but also accessory cells that support angiogenesis andvasculogenesis by producing several growth factors and cytokines.” (Saigawaet al; Circulation Journal; vol. 68, December 2004; 68:1189-1193). Untilnow, it has been difficult to process and concentrate a clinicallysignificant dose of adult stem cells from a patient’s bone marrow at thepoint-of-care.
“I wish this BMAC technology were available to doctors here in the UnitedStates,” said Don Freeman, 54, of Belchertown, Mass., a former hospitaladministrator who suffers from osteonecrosis of the shoulders, ankles andknees, has had two hip replacements because of osteonecrosis and has beendisabled as a result of his osteonecrosis for seven years. “The clinicalexperiences in Europe are showing that Harvest’s BMAC System is making iteasy and quick for clinicians to process and concentrate cellularcompositions from bone marrow that include a significant amount of adultstem cells. This is being done safely and rapidly in Europe to aid inpoint-of-care treatment of osteonecrosis and other hard-to-treat diseases,so why not here in the United States?”
In the U.S., the BMAC System is currently marketed for use in “…theclinical laboratory or intraoperatively at point-of-care for the safe andrapid preparation of…a cell concentrate from bone marrow.” As the safetyand effectiveness of the BMAC System for in vivo use has not beenestablished in the U.S., Harvest is actively in discussions with the FDA tocommence a multicenter clinical trial of this treatment modality. Harvestintends to conduct a six-site IDE clinical trial using the BMAC System forthe treatment of patients with Critical Limb Ischemia (CLI), which is thelater stage of Peripheral Arterial Occlusive Disease (PAOD) — cloggedarteries, particularly in the lower legs. Patients with CLI are at extremerisk for amputation. Reportedly, approximately 500,000 people worldwidesuffer from CLI, and about 160,000 amputations are performed each year inthe U.S. as a result of this condition (source: The Sage Group). A recentpilot study conducted in Berlin, Germany, using the BMAC System to treatCLI patients showed a 60 percent reduction in amputations. An additionalrandomized prospective clinical trial for the treatment of CLI is plannedto commence in Europe.
Harvest Technologies is a privately held company based in Plymouth, Mass.
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