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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00623610
• Other study ID #: BK-Tx-04
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 19, 2008
• Last updated: February 19, 2008
• Start date: September 2000
• Est. completion date: October 2005

Study information

• Verified date: February 2008
• Source: AZ-VUB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Procedure:
• islet cell grafts
Intraportal injection of an islet cell graft into the liver.

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB	Brussels
Belgium	Department of Endocrinology and Nephrology, UZ Gasthuisberg, Katholieke Universiteit Leuven -KUL	Leuven

Sponsors (5)

Lead Sponsor	Collaborator
AZ-VUB	Erasme University Hospital, Universitaire Ziekenhuizen Leuven, Universiteit Antwerpen, Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

Keymeulen B, Gillard P, Mathieu C, Movahedi B, Maleux G, Delvaux G, Ysebaert D, Roep B, Vandemeulebroucke E, Marichal M, In 't Veld P, Bogdani M, Hendrieckx C, Gorus F, Ling Z, van Rood J, Pipeleers D. Correlation between beta cell mass and glycemic contr — View Citation

Maleux G, Gillard P, Keymeulen B, Pipeleers D, Ling Z, Heye S, Thijs M, Mathieu C, Marchal G. Feasibility, safety, and efficacy of percutaneous transhepatic injection of beta-cell grafts. J Vasc Interv Radiol. 2005 Dec;16(12):1693-7. — View Citation

Movahedi B, Keymeulen B, Lauwers MH, Goes E, Cools N, Delvaux G. Laparoscopic approach for human islet transplantation into a defined liver segment in type-1 diabetic patients. Transpl Int. 2003 Mar;16(3):186-90. Epub 2003 Feb 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of clinically relevant beta cell function.		2 years	No