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

Sponsor

AZ-VUB (Other)

Overall Status

Completed

CT.gov ID

NCT00623610

Collaborator

Vrije Universiteit Brussel (Other), Universitaire Ziekenhuizen Leuven (Other), Universiteit Antwerpen (Other), Erasme University Hospital (Other)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1	Procedure: islet cell grafts	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2000

Actual Primary Completion Date :

Oct 1, 2005

Actual Study Completion Date :

Oct 1, 2005

Outcome Measures

Primary Outcome Measures

Evidence of clinically relevant beta cell function. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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:

history of thrombosis or pulmonary embolism
abnormal liver function
HLA antibodies

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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