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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:

U.S. FDA Resources

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
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 May 23, 2013