Beta-Cell Transplantation in Pre-Uremic Patients With Type 1 Diabetes
Phase 1
Completed
- Conditions
- Diabetes Mellitus, Type 1
- Registration Number
- NCT00623610
- Lead Sponsor
- AZ-VUB
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- 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 Criteria
- history of thrombosis or pulmonary embolism
- abnormal liver function
- HLA antibodies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Evidence of clinically relevant beta cell function. 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Universitair Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB
🇧🇪Brussels, Belgium
Department of Endocrinology and Nephrology, UZ Gasthuisberg, Katholieke Universiteit Leuven -KUL
🇧🇪Leuven, Belgium
Universitair Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB🇧🇪Brussels, Belgium