Our objective is the reversal of Type 1 diabetes mellitus by clinical fetal pancreas (FP) transplantation. FP is an available source of islets that have the capacity to multiply. In diabetic rats, we found that Insulin-like Growth Factor-1 (IFG-1) stimulated FP to engraft, proliferate and correct diabetes when implanted in the intramuscular site. We have transplanted one histocompatible 18-week fetal pancreas into the forearm muscle of a patient with Type 1 diabetes who had a successful kidney transplant with stable function on maintenance immunosuppression. The recipient then received twice daily IGF-1 injections directly into the transplant site for 14 days. The patient's insulin requirement decreaed by 10% and C-peptide blood levels increased in response to intravenous arginine 90 days and 6 months after transplantation. There were no adverse consequences. We propose to expand this clinical trial to ten recipients using a larger inoculum of at least six cryopreserved FP in an effort to establish normoglycemia without exogenous insulin.
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