Applied Immune Sciences Inc. (AIS) announced Tuesday that ithas submitted a 510(k) application to the FDA for marketingclearance on its CELLector device for selecting T cells.
The CELLector has been used as a T cell depletion device inclinical trials on bone marrow transplantation (BMT)procedures of the allogeneic sort, in which the marrow is takenfrom either matched-related or matched-unrelated donors. TheT cells are removed from the donor's marrow prior toimplantation.
According to Thomas Okarma, president and chief executiveofficer of the Santa Clara, Calif. company (NASDAQ:AISX), T celldepletion might become a significant factor in preventing graft-vs.-host disease, the most common complication of allogeneictransplantation, in which the donor's marrow rejects therecipient's tissue.
The CELLector has already been used for T cell depletion in 44matched-related BMT procedures, with full engraftment in 41patients. Clinicals on matched-unrelated transplants are beingplanned. -- Jennifer Van Brunt
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