Aastrom received FDA approval to initiate multi-center trial for bone graft product.Aastrom Biosciences, Inc., Ann Arbor, MI, announced that the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. has approved its Investigational New Drug (IND) application for a multi-center Phase I/II clinical trial for the company's bone generation Tissue Repair Cell (TRC TRC Noun (in South Africa) Truth and Reconciliation Commission: a commission which encourages people who committed human rights abuses or acts of terror during the apartheid era to reveal the truth about their crimes in return for immunity from prosecution ) stem cell product. The study will allow Aastrom's TRCs to be used at up to 3 centers for the treatment of tibial tibial pertaining to the tibia. tibial crest a longitudinal prominence on the cranial border of the proximal tibia. Its proximal end (tibial tubercle) has a growth plate separate from the proximal tibia; hyperflexion injuries to non-union fractures. The company says if the trial is successful it could lead to a viable alternative to the current, highly morbid standard of treatment for use in the multi-million dollar bone graft market. Aastrom says the bone graft trial protocol will combine its TRCs with a standard orthopedic matrix, to be provided by the Musculoskeletal musculoskeletal /mus·cu·lo·skel·e·tal/ (-skel´e-t'l) pertaining to or comprising the skeleton and muscles. mus·cu·lo·skel·e·tal adj. Relating to or involving the muscles and the skeleton. Transplant Foundation (MTF (1) (Modulation Transfer Function) A measurement of monitor sharpness. MTF compares the contrast ratio between alternating black and green lines that are one pixel thick. ), Edison, NJ. The company anticipates the trial will be conducted concurrently with other planned trials in Europe that are intended to demonstrate the safety and efficacy of TRSs for bone graft indications. Contact: Becky Anderson - (734) 930-5777, Web site: www.aastrom.com. |
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