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

Tracking Information

First Received Date ^ICMJE

February 19, 2008

Last Updated Date

February 19, 2008

Start Date ^ICMJE

September 2000

Primary Completion Date

October 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus, Type 1

Intervention ^ICMJE

Procedure: islet cell grafts

Intraportal injection of an islet cell graft into the liver.

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2005

Primary Completion Date

October 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT00623610

Other Study ID Numbers ^ICMJE

BK-Tx-04

Has Data Monitoring Committee

Responsible Party

Bart Keymeulen, Universitair Ziekenhuis Brussel

Study Sponsor ^ICMJE

AZ-VUB

Collaborators ^ICMJE

Vrije Universiteit Brussel
Universitaire Ziekenhuizen Leuven
Universiteit Antwerpen
Erasme University Hospital

Investigators ^ICMJE

Principal Investigator:

Bart Keymeulen, MD, PhD

Universitair Ziekenhuis Brussel

Information Provided By

AZ-VUB

Verification Date

February 2008

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

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