Islet transplantation can provide physiologic insulin replacement to patients with type 1
diabetes without the complications associated with whole pancreas transplantation. The
purpose of this study is to achieve insulin-independence in patients with type 1 diabetes,
thereby eliminating the need for exogenous insulin injections to maintain normal glucose
levels, ameliorating severe hypoglycemia and potentially decreasing the development of
diabetes-related complications. This study will investigate islet transplantation in subjects
who have preserved renal function and subjects who have undergone cadaveric renal
transplantation, since the latter subjects are already on immunosuppression.
This is a single center, prospective trial of islet transplantation in subjects receiving
islets alone or islets after kidney transplant. This is a phase I study investigating the use
of islet transplantation for the treatment of type 1 diabetes. Subjects will be eligible for
an islet transplant if they meet all of the inclusion criteria and none of the exclusion
criteria outlined in the protocol. In brief, the aims of this study are to establish an islet
transplant program at the Ohio State University, determine the safety of islet
transplantation in islet alone and kidney transplant recipients, determine whether islet
transplantation will reduce the frequency of severe hypoglycemic events, determine whether a
novel steroid-free immunosuppressive protocol will prevent rejection in islet transplants and
to achieve insulin independence at one year after the final islet transplant.