NEWS: PLURISTEM COLLABORATES/STARTS HUMAN TRIALS IN GERMANY FOR P.A.D.
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Jan 27, 2009 02:43AM
Adult stem cell development company commencing clinical trials applicable to estimated $30 billion degenerative disease market place
Pluristem plans to initiate its dose ranging clinical trials at the Charité and the Franziskus-Krankenhaus hospitals by administering PLX-PAD to patients afflicted with critical limb ischemia who have not responded to traditional medical or surgical interventions and are facing amputation.
“Signing an agreement with the Charite, a well respected European institution, was accomplished following the successful collection of double blinded preclinical efficacy and safety data, so the translation to the human clinical trial looks very promising,” stated Zami Aberman, Chairman, President and CEO of Pluristem. “We are honored to collaborate with the Hospital and the Berlin-Brandenburg Center for Regenerative Medicine (BCRT).” Mr. Aberman also stated: “Signing an agreement with the Franziskus-Krankenhaus Hospital is also very appropriate, due to the Hospital’s considerable experience and expertise in human stem cell studies in peripheral artery disease (PAD).”
About BCRT
The Berlin-Brandenburg Center for Regenerative Therapies (BCRT), an integral part of Charité Universitätsmedizin, Berlin, one of Europe’s largest university hospitals, located within Europe’s leading biotechnology region, developed an internationally visible center of excellence in regenerative medicine with a focus on targeted cell differentiation for promoting endogenous tissue regeneration and translating basic science discoveries into regenerative therapies. The BCRT is also sharing its scientific knowledge in regenerative medicine with researchers, clinicians, industry and the public through educational activities, training, publications, and communication forums at national and international levels.
About Franziskus Hospital
Franziskus Hospital, managed by the Sisters of the Franziskus Order and located in Berlin, is a medical and teaching hospital dedicated to the treatment of vascular disorders. It is composed of three main departments: Vascular Medicine, Surgery and Intervention. With approximately 180 beds, Franziskus Hospital is Germany’s largest vascular center with more than 15,000 patients per year treated for venous or arterial disorders. The hospital has a unique focus on the cell-based therapy of arterial occlusive disease.
About Critical Limb Ischemia
In the US alone, it is estimated that 8-12 million people suffer from limb ischemia associated with peripheral artery diseases (PAD). The disease is characterized by narrowing and hardening of the arteries in the patient’s limb(s) caused and/or aggravated by diabetes, Buerger's Disease, other diseases and smoking. With decreased blood flow to the affected extremity, patients can suffer a host of complications including nerve and tissue damage. In advanced stages, limb ischemia can lead to gangrene, which often requires treatment with amputation. The disease is associated with a high rate of mortality and the need for frequent hospitalization from surgical complications.