CLINICAL TRIALS ON HUMAN ISLET TRANSPLANTATION

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DESCRIPTION: (Adapted from the applicant's abstract) The first specific aim of this application is to determine how many insulin dependent diabetes mellitus patients can achieve insulin independence by islet transplants, and how long their grafts will last, in two groups of patients. The first study is to transplant 7 day, 24 degrees C cultured and cryopreserved islets into Type I patients with established kidney transplants with 7 days of MALG and basal immunosuppression. The second study is to transplant 7 day, 24 degrees C cultured and cryopreserved islets into patients getting their kidney transplant. With this information obtained, the next step will be to determine the ability of immunoalteration techniques to permit transplantation without long term immunosuppression. The second specific aim is to transplant 7 day cultured, cryopreserved islets into Type I patients entering renal failure who will have their islets treated with either culture and cryopreservation, multiple donors, UV light therapy, or specific anti-class II antibodies prior to transplantation. The successful completion of these studies will determine the practical feasibility of islet transplantation to achieve its long term objective.