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Aastrom Biosciences announces first trial of Tissue Repair Cells for regeneration of vascular tissue cells in diabetics.

Aastrom Biosciences, Inc., Ann Arbor, MI, announced that the first clinical trial utilizing the company's proprietary Tissue Repair Cells (TRCs) to treat limb ischemia in diabetic patients has been initiated at the Diabetes Center at the Heart and Diabetes Center North Rhine-Westphalia (Diabetes Center) located in Bad Oeynhausen, Germany. Aastrom says initiation of the trial followed the Diabetes Center's receipt of the licenses and the Investigational Medicinal Product Dossier (IMPD) necessary to manufacture and use cells for clinical trials in compliance with the new European Union directives.

The aim of the study is to evaluate the safety and ability of Aastrom's bone marrow-derived TRCs to regenerate functioning blood vessels in the legs of diabetic patients with limb ischemia. The company says it is intended that the patients may experience relief from clinical problems that are related to a loss of blood circulation, such as: deep "bed-sore type" ulcerated wounds of the feet, pain, immobility, and infection.

Over the 12 months following treatment, the trial will evaluate whether the TRC treatment results in improved or complete healing of ulcers, as well as whether amputation can be avoided or delayed. The trial will also monitor the time to relapse if complete healing is not attended, and whether the prognosis for patient survival improves, compared to standard of care controls.

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Title Annotation:clinical trials
Comment:Aastrom Biosciences announces first trial of Tissue Repair Cells for regeneration of vascular tissue cells in diabetics.(clinical trials)
Publication:Transplant News
Article Type:Brief Article
Geographic Code:1USA
Date:Oct 15, 2005
Previous Article:Atrium Medical, Isotechnika announce licensing agreements for use of new drugs with medical devices.
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