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

This study has been completed.
Sponsor:
Collaborators:
Vrije Universiteit Brussel
Universitaire Ziekenhuizen Leuven
Universiteit Antwerpen
Erasme University Hospital
Information provided by:
AZ-VUB
ClinicalTrials.gov Identifier:
NCT00623610
First received: February 19, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 1
Procedure: islet cell grafts
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Beta-Cell Transplantation in Pre-Uremic Patients With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by AZ-VUB:

Primary Outcome Measures:
  • Evidence of clinically relevant beta cell function. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: September 2000
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: islet cell grafts
    Intraportal injection of an islet cell graft into the liver.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623610

Locations
Belgium
Universitair Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB
Brussels, Belgium, 1090
Department of Endocrinology and Nephrology, UZ Gasthuisberg, Katholieke Universiteit Leuven -KUL
Leuven, Belgium, 3000
Sponsors and Collaborators
AZ-VUB
Vrije Universiteit Brussel
Universitaire Ziekenhuizen Leuven
Universiteit Antwerpen
Erasme University Hospital
Investigators
Principal Investigator: Bart Keymeulen, MD, PhD Universitair Ziekenhuis Brussel
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bart Keymeulen, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT00623610     History of Changes
Other Study ID Numbers: BK-Tx-04
Study First Received: February 19, 2008
Last Updated: February 19, 2008
Health Authority: Belgium: Institutional Review Board

Keywords provided by AZ-VUB:
Diabetes mellitus, type 1
pancreatic beta cell
transplantation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 19, 2014