CELL THERAPY: Cell Separation System Approved
BioTransplant, Inc. (Building 75, Third Ave., Charlestown Navy Yard, Charlestown, MA 02120; Tel: 617/241-5200, Fax: 617/241-8780) has received European Union authorization to affix the CE Mark to its third HDM Cell Separation product, signifying regulatory approval to market the device in Europe. This product, the Eligix CD8-SC Cell Separation System, is intended for ex-vivo use for patients receiving allogeneic bone marrow and peripheral stem cell transplantation for hematological disorders. Two other HDM Cell Separation products have previously received CE Mark approval-the CD8-DLI and BCell-SC systems.
Roughly 17,000 patients per year undergo allogeneic stem cell transplantation worldwide, with 40% of the patient population based in Europe.
The CD8-SC Cell Separation System effects the removal of CD8+ T cells from donor stem cell transplants, and is the only commercially available product in Europe for this indication.
“The Eligix CD8-SC Cell Separation System has the potential to bring significant benefits to the European cancer patient population. With the help of Gambro, our sales and marketing partner, we intend to make this product widely available in Europe,” comments Donald Hawthorne, CEO of BioTransplant.
Allogeneic transplantation is used to treat a wide range of hematological disorders. However, due to immunological incompatibilities between the donor and the recipient, Graft- versus-Host Disease (GVHD) can occur, a potentially lethal complication that has been linked to the infusion of donor CD8+ T cells.
Preclinical studies using the Eligix Cell Separation System were presented at the European Bone Marrow Transplant Annual Meeting in April 2002. The majority of CD8+ T cells were selectively removed from the allograft, while the immune cells and stem cells that are necessary to repopulate the bone marrow and develop into the different blood cells were preserved. In addition, Robert Soiffer, clinical director of the Hematologic Oncology Center and the co- director of the Adult Hematopoietic Stem Cell Transplantation Program at the Dana Farber Cancer Institute, recently presented results suggesting that CD8 depletion of allogeneic stem cells may be performed effectively without impairing engraftment using the Eligix Cell Separation System.
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