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

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

This study has been completed.

Sponsors and Collaborators:	AZ-VUB Vrije Universiteit Brussel Universitaire Ziekenhuizen Leuven Universiteit Antwerpen Erasme University Hospital
Information provided by:	AZ-VUB
ClinicalTrials.gov Identifier:	NCT00623610

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 I Phase II

MedlinePlus related topics: Diabetes Diabetes Type 1

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Beta-Cell Transplantation in Pre-Uremic Patients With Type 1 Diabetes

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:

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 of Results:

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 control in type 1 diabetic recipients of islet cell graft. Proc Natl Acad Sci U S A. 2006 Nov 14;103(46):17444-9. Epub 2006 Nov 7.

Other Publications:

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.

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.

Publications indexed to this study:

Huurman VA, Hilbrands R, Pinkse GG, Gillard P, Duinkerken G, van de Linde P, van der Meer-Prins PM, Versteeg-van der Voort Maarschalk MF, Verbeeck K, Alizadeh BZ, Mathieu C, Gorus FK, Roelen DL, Claas FH, Keymeulen B, Pipeleers DG, Roep BO. Cellular islet autoimmunity associates with clinical outcome of islet cell transplantation. PLoS ONE. 2008 Jun 18;3(6):e2435.

Responsible Party:	Universitair Ziekenhuis Brussel ( Bart Keymeulen )
Study ID Numbers:	BK-Tx-04
Study First Received:	February 19, 2008
Last Updated:	February 19, 2008
ClinicalTrials.gov Identifier:	NCT00623610
Health Authority:	Belgium: Institutional Review Board

Keywords provided by AZ-VUB:

Diabetes mellitus, type 1
pancreatic beta cell
transplantation

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009