Type 1 Diabetes Mellitus Clinical Trial
Official title:
Pathways to Tolerance in Human Islet Transplantation
The goal of islet cell transplantation in Type 1 diabetics is to provide those affected with
constant normal blood glucose levels, thereby reducing or eliminating altogether the need
for injected insulin. This normalization may prevent or slow progression of diabetic
complications, result in a healthier lifestyle, and lead to a better quality of life.
Participants who meet the inclusion criteria will undergo an extensive screening process
which typically includes a series of blood tests, EKG, chest x-rays, and a psychological
evaluation, among others. Those who are eligible for and chose to participate in the trial
will receive an islet cell transplant and bone marrow infusion from the same donor, together
with following immunosuppressive medications: tacrolimus, sirolimus, daclizumab and
infliximab. Because the bone marrow infusion may successfully prevent the transplanted islet
cells from rejecting, some participants may be able to stop taking the immunosuppressive
medications after a year.
The islet cell transplant is done under local anesthesia in a special procedure radiology
room. Several days after the islet cell transplant, the participant is admitted to the
hospital as an outpatient in order to receive bone marrow via a simple intra-venous infusion
procedure.
All participants will need to be seen at the Diabetes Research Institute after the
transplant for follow-up testing and post-islet cell transplant care.
n/a
Masking: Open Label, Primary Purpose: Treatment
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