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This device will be used with CellPro's current product, the CEPRATE SC Stem Cell Concentration System, to reduce the number of T-lymphocytes in peripheral blood stem cells used for allogeneic transplantation.
Allogeneic transplantation is the transplantation of stem cells (obtained from bone marrow or peripheral blood) that are obtained from family donors (such as siblings) or from unrelated donors who are located through a registry of volunteers. Allogeneic transplants are used to treat patients with a variety of hematologic disorders such as leukemia.
A common side-effect encountered in recipients of allogeneic transplants is graft-versus-host disease (GVHD) which is an immunologic reaction of donor T-lymphocytes against the patient receiving the transplant. GVHD can be severe and sometimes fatal, especially in patients who receive transplants from donors who are not genetically-matched with the patient. Reducing the number of lymphocytes in allogeneic bone marrow transplants has previously been shown to reduce GVHD.
The trial announced by CellPro today will enroll children with leukemias who need a stem cell transplant, but have no genetically-matched siblings to serve as a donor or for whom no phenotypically-matched unrelated donor can be found. The children in this trial will instead receive peripheral blood cell transplants from a family member (usually a parent) who is only partially genetically-matched. The peripheral blood cells will be processed using the CEPRATE SC and TCD Systems to first concentrate the stem cells and then reduce the number of T-lymphocytes.
"We are very pleased to begin clinical trials with this major new product," said Larry Culver, chief operating officer and chief financial officer of CellPro. "If proven to be safe and effective, use of the CEPRATE TCD System could revolutionize allogeneic transplantation by making the process safer and greatly expanding the pool of potential donors for patients who need transplants but currently have no donor."
"In addition," says Culver, "development of this product, which is based on the same immunoselection technology utilized in the CEPRATE SC System, demonstrates the versatility of CellPro's core technology platform. The ability to build on our existing technology has enabled CellPro to be the first company to combine the important step of positive stem cell selection with a negative depletion step in a closed system, and the first company to commence clinical trials with such a product. Development of the CEPRATE TCD System is a major step toward enabling physicians to precisely engineer stem cell grafts for their patients."
The clinical trial is designed to evaluate the proportion of patients with successful engraftment of donor stem cells and the proportion who develop GVHD. The trial will enroll approximately twenty-five patients at five centers in the United States and Canada: the Fred Hutchinson Cancer Research Center (Seattle), Emory University School of Medicine (Atlanta), The University of Minnesota (Minneapolis), Stanford University (Palo Alto, Calif.), and The Hospital for Sick Children (Toronto).
Located in Bothell, CellPro Inc. is a biotechnology company that develops, manufactures and markets proprietary continuous-flow, cell-selection systems for use in a variety of therapeutic, diagnostic and research applications. Its CEPRATE SC Stem Cell Concentration System is approved for sale in 18 European countries and Canada. Its Premarketing Approval Application for use in bone marrow transplantation was recently deemed approvable by the U.S. Food and Drug Administration; however, it is still restricted to investigational use in the United States.
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CONTACT: CellPro Inc. Joann Reiter, 206/485-7644 e-mail: invest@cellpro.com http://www.cellpro.com
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