Diabetes Mellitus, Type 1
Conditions
Keywords
Diabetes mellitus, type 1, pancreatic beta cell, transplantation
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.
Interventions
PROCEDUREislet cell grafts
Intraportal injection of an islet cell graft into the liver.
Sponsors
Vrije Universiteit Brussel
Universitaire Ziekenhuizen KU Leuven
Universiteit Antwerpen
Erasme University Hospital
AZ-VUB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evidence of clinically relevant beta cell function. | 2 years |
Countries
Belgium
Outcome results
None listed