CellPro's CEPRATE SC System to be reviewed by FDA panel.SEATTLE--(BUSINESS WIRE)--Dec. 20, 1995--CellPro Inc. today announced that it had received notification from the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (FDA) that the company's pre-market approval application (PMA) for the CEPRATE(R) SC Stem Cell Concentration System would be reviewed by the FDA's Biological Response Modifiers biological response modifiers, n.pl substances such as phytochemicals and fibers that modulate mech-anisms related to the development of disease, such as hormonal changes, immune function, inflammatory activity, oxidative stress, and home-ostasis. Advisory Committee at their next meeting. This meeting is expected to occur in late February 1996. The CEPRATE SC System completed a Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the in autologous bone marrow transplantation autologous bone marrow transplantation Transplantation medicine The administration to an individual 'X' of his/her own BM, often to a leukemic Pt in relapse who, because a suitable HLA-matched donor is not available, would otherwise die of the disease. See Bone marrow. in May 1993, and CellPro filed a PMA with the FDA in December of that year. In December 1994, the FDA requested additional information from the company, which was provided to the agency in August and September 1995. The CEPRATE SC System is CellPro's first product to complete clinical testing in the United States. The CEPRATE SC System is a medical device that separates human stem cells from the other cells of the bone marrow or peripheral blood. Stem cells are rare "mother" cells that can both replicate themselves and produce all of the cells of the body's blood and immune systems: white blood cells White blood cells A group of several cell types that occur in the bloodstream and are essential for a properly functioning immune system. Mentioned in: Abscess Incision & Drainage, Bone Marrow Transplantation, Complement Deficiencies to fight disease; red blood cells Red blood cells Cells that carry hemoglobin (the molecule that transports oxygen) and help remove wastes from tissues throughout the body. Mentioned in: Bone Marrow Transplantation red blood cells to transport oxygen throughout the body and platelets to promote blood clotting. In bone marrow transplantation Bone Marrow Transplantation Definition The bone marrow—the sponge-like tissue found in the center of certain bones—contains stem cells that are the precursors of white blood cells, red blood cells, and platelets. , and similar procedures, the transplanted stem cells are generally considered to be the key cells in repopulating the marrow following marrow-killing chemotherapy, or radiotherapy, to treat cancer and other diseases or disorders. CellPro began sales of the CEPRATE SC System in Europe during 1993. The product received the CE mark for marketing approval from the 18-nation European Economic Union in July 1995 and ISO 9002 quality certification in September 1995. In addition to countries in Europe, the company has marketing approval for the CEPRATE SC System in Canada. The CEPRATE SC System is currently being used in clinical trials for various applications at over 175 institutions in the United States and Europe. The company's CEPRATE LC Laboratory Cell Separation System line of products for nonclinical research is available worldwide. CellPro Inc. is a biotechnology company, based in Bothell, Wash., that develops, manufactures and markets proprietary, continuous-flow, cell-selection systems for use in a variety of therapeutic, diagnostic and research applications. CONTACT: CellPro Inc., Bothell Lee M. Parker, 206/485-7644 |
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