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ASTM |
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STEM CELL RESEARCH |
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AASTROM BIOSCIENCES |
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Tissue regeneration therapies through the use of autologous stem cell products is the firm’s focus. Aastrom’s platform manufacturing technology enables the production of patient-specific cell products with multiple tissue regenerative capabilities from a small sample of the patient's bone marrow.
Technology: Tissue Repair Cell (TRC) technology. The TRC-based products are comprised of a unique cell mixture containing stem and progenitor cell populations produced from a small amount of bone marrow taken from the patient.TRC-based products have been used in over 230 patients, and are currently in clinical trials for bone regeneration (long bone fractures and spine fusion) and vascular regeneration (critical limb ischemia) applications.
Products: Aastrom has reported positive interim clinical trial results for TRC-based cells. Clinical studies demonstrated safety and the ability of tissue repair cells to promote healing in bone regeneration. TRCs received Orphan Drug Designation from the FDA for use in the treatment of osteonecrosis of the femoral head. In addition, Aastrom is developing plans for TRC-based therapies to address cardiac and neural regeneration indications.
Development programs: Four in research, preclinical and clinical trials.
Bone regeneration Phase 1/2 trials; Phase 2b planned in 2007 Critical limb ischemia Phase 1/2 trials; Phase 2b planned in 2007 Cardiac regeneration in preclinical trials; Phase 1/2 planned for 2007 Neural regeneration R&D; preclinical testing planned for 2007 Jan. 17, 2007: The first two patients with osteonecrosis (avascular necrosis) have been treated in a pivotal clinical trial utilizing the company's Tissue Repair Cells (TRCs). The trial sponsored by Aastrom is being conducted at Centro Medico Teknon (Teknon) located in Barcelona, Spain. Aastrom initiated patient enrollment and treatment after receiving written approval from the Spanish Drug Agency (AEMPS) and Teknon's Ethics Committee for the company's Investigational Medicinal Product Dossier (IMPD).
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