Type 1 Diabetes Mellitus Clinical Trial
Official title:
Islet Cell Transplantation Alone and CD34+ Enriched Donor Bone Marrow Cell Infusion in Patients With Type 1 Diabetes Mellitus; Steroid Free Regimen
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. ;
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