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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00623610
First Posted: February 26, 2008
Last Update Posted: February 26, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Vrije Universiteit Brussel
Universitaire Ziekenhuizen Leuven
Universiteit Antwerpen
Erasme University Hospital
Information provided by:
AZ-VUB
February 19, 2008
February 26, 2008
February 26, 2008
September 2000
October 2005   (Final data collection date for primary outcome measure)
Evidence of clinically relevant beta cell function. [ Time Frame: 2 years ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Beta-Cell Transplantation in Pre-Uremic Patients With Type 1 Diabetes
Beta-Cell Transplantation in Pre-Uremic Patients With Type 1 Diabetes
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.
Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus, Type 1
Procedure: islet cell grafts
Intraportal injection of an islet cell graft into the liver.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
October 2005
October 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT00623610
BK-Tx-04
No
Not Provided
Not Provided
Bart Keymeulen, Universitair Ziekenhuis Brussel
AZ-VUB
  • Vrije Universiteit Brussel
  • Universitaire Ziekenhuizen Leuven
  • Universiteit Antwerpen
  • Erasme University Hospital
Principal Investigator: Bart Keymeulen, MD, PhD Universitair Ziekenhuis Brussel
AZ-VUB
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP