Beta-Cell Transplantation in Pre-Uremic Patients With Type 1 Diabetes

AZ-VUB

Status and phase

Completed

Phase 2

Phase 1

Conditions

Diabetes Mellitus, Type 1

Treatments

Procedure: islet cell grafts

Study type

Interventional

Funder types

Other

Identifiers

NCT00623610

BK-Tx-04

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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