Status:
COMPLETED
Islet Transplantation in Type 1 Diabetic Patients
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Our hypothesis is that a successful clinical islet transplant program can be established at the University of Wisconsin using a steroid -free, sirolimus- and low dose tacrolimus - based immunosuppress...
Eligibility Criteria
Inclusion
- 16 Type I insulin-dependent diabetic subjects ages 18-60,(8 who have received a prior kidney or liver transplant and have stable renal function, and 8 who have labile glucose regulation and who have failed a trial of intensive exogenous insulin therapy and who have preserved native renal function)
Exclusion
- untreated proliferative diabetic retinopathy;
- HgbA1C \>12%; creatinine clearance \< 80 ml/minute or macroalbuminuria \> 0.3 gm/24 hrs;
- presence of panel reactive antibodies \>20%
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00214253
Start Date
February 1 2002
End Date
October 1 2011
Last Update
March 31 2017
Active Locations (1)
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1
University of Wisconsin
Madison, Wisconsin, United States, 53792