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

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ClinicalTrials.gov Identifier: NCT00623610
Recruitment Status : Completed
First Posted : February 26, 2008
Last Update Posted : February 26, 2008
Sponsor:
Collaborators:
Vrije Universiteit Brussel
Universitaire Ziekenhuizen Leuven
Universiteit Antwerpen
Erasme University Hospital
Information provided by:
AZ-VUB

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
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 : September 2000
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arms and Interventions
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Intervention Details:
    Procedure: islet cell grafts
    Intraportal injection of an islet cell graft into the liver.

Outcome Measures
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Primary Outcome Measures :
  1. Evidence of clinically relevant beta cell function. [ Time Frame: 2 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Other Publications:

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
First Posted: February 26, 2008    Key Record Dates
Last Update Posted: February 26, 2008
Last Verified: February 2008

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