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Aastrom Biosciences receives orphan product designation from FDA for bone marrow stem cell product.

Aastrom Biosciences, Inc., Ann Arbor, MI announced the FDA has granted orphan product status to the company's SC-1 autologous bone marrow stem cells using its AastromReplicell System. The company says its therapeutic ex vivo-produced bone marrow stem cells received the designation for use in cancer patients requiring a stem cell transplant following high-dose chemotherapy, but who are unable to obtain sufficient numbers of blood stem cells for adequate treatment using current transplant methods.

The FDA awards orphan product classification to new approaches that may offer therapeutic value for the treatment of rare diseases and conditions. Products receiving the designation may be entitled to entitled to expedited FDA review. In addition the company would be entitled to marketing exclusivity for 7 years should the product ultimately receive FDA approval.

Contact: Glenn Silver - (212) 845-4259, Web site -
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Comment:Aastrom Biosciences receives orphan product designation from FDA for bone marrow stem cell product.
Publication:Transplant News
Article Type:Brief Article
Geographic Code:1USA
Date:Jul 27, 2002
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