Status:
COMPLETED
Beta-Cell Transplantation in Pre-Uremic Patients With Type 1 Diabetes
Lead Sponsor:
AZ-VUB
Collaborating Sponsors:
Vrije Universiteit Brussel
Universitaire Ziekenhuizen KU Leuven
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
To examine whether temporary immunosuppression with ATG, tacrolimus and MMF allows prolonged survival of beta cell allografts in type 1 diabetic patients with early chronic complications of diabetes.
Eligibility Criteria
Inclusion
- type 1 insulin-dependent diabetic patients in relatively good general condition
- non-smoker
- body weight \< 80 kg
- C-peptide \< 0.03 nmol/l (\<0.09 µg/l) 6 min. after glucagon IV (1mg) (glycemia \> 180 mg/dl)
- EBV antibody positive
- cooperative and reliable patient giving informed consent by signature; the patient should be informed in sufficient detail on the content and procedure of the protocol, indicating potential risks of intervention and of immunosuppressive therapy; the patient should also be informed that withdrawal of immunosuppressive therapy in patients with persistent plasma C-peptide positivity may result in subsequent loss of ß-cell graft function; the ß cell implant should be identified as a clinical trial
Exclusion
- history of thrombosis or pulmonary embolism
- abnormal liver function
- HLA antibodies
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00623610
Start Date
September 1 2000
End Date
October 1 2005
Last Update
February 26 2008
Active Locations (2)
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1
Universitair Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB
Brussels, Belgium, 1090
2
Department of Endocrinology and Nephrology, UZ Gasthuisberg, Katholieke Universiteit Leuven -KUL
Leuven, Belgium, 3000