SPECIFIC AIMS: * To reverse hyperglycemia and insulin dependency in patients with Type 1 diabetes mellitus by islet cell transplantation. * To induce a state of donor specific tolerance and eliminate the need for continuous immunosuppressive therapy by simultaneous transplantation of donor bone marrow cells with islets and utilization of the monoclonal antibody Campath-1H for induction of Immunosuppression. * To assess long-term function of successful islet cell transplants in patients with Type 1 diabetes mellitus. * To determine whether the natural history of the microvascular, macrovascular and neuropathic complications are altered following successful transplantation of islet
In our current protocol (IRB #2000/0024) the immunosuppressive regimen, comprised of induction with daclizumab and maintenance therapy with sirolimus and tacrolimus, has been combined with the infusion of CD34+ enriched donor bone marrow stem cells in an attempt to create a chimeric state and hence induce donor tolerance. This strategy was tested by evaluating graft survival following the removal of all immunosuppressive medication after one year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Islet transplantation and CD34 Bone Marrow infusion in subjects with type 1 diabetes.
Diabetes Research Institute
Miami, Florida, United States
The Achievement of Persistent Islet Function Following Cessation of Immunosuppression.
Immunosuppression was never discontinued. Patients elected to move to other trials to receive additional islet infusions. Since immunosuppression was never discontinued we were not able to evaluate the primary endpoint.
Time frame: for the duration of islet graft function
A Reduction or Absence of Rejection Episodes
Number of rejection episodes after transplantation. Immunosuppression was never discontinued. Patients elected to move to other trials to receive additional islet infusions. Since immunosuppression was never discontinued we were not able to evaluate the primary endpoint.
Time frame: for the duration of islet graft function
Number of Subjects With Basal C-peptide Greater Than 0.5 ng/ml
Number of subjects with basal C-peptide greater than 0.5 ng/ml prior to weaning of immunosuppression;
Time frame: for the duration of islet graft function
Number of Subjects With Reduction of Severe Hypoglycemia and Improvement in Hypoglycemia Awareness
Number of subjects with reduction of episodes of severe hypoglycemia and the presence of awareness of hypoglycemia
Time frame: for the duration of islet graft function
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