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

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 1 Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Beta-Cell Transplantation in Pre-Uremic Patients With Type 1 Diabetes

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Type 1

U.S. FDA Resources

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 (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

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.

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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ling Z, De Pauw P, Jacobs-Tulleneers-Thevissen D, Mao R, Gillard P, Hampe CS, Martens GA, In't Veld P, Lernmark Å, Keymeulen B, Gorus F, Pipeleers D. Plasma GAD65, a Marker for Early β-Cell Loss After Intraportal Islet Cell Transplantation in Diabetic Patients. J Clin Endocrinol Metab. 2015 Jun;100(6):2314-21. doi: 10.1210/jc.2015-1216. Epub 2015 Mar 27.

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. doi: 10.1371/journal.pone.0002435.


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

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

ClinicalTrials.gov processed this record on September 26, 2016

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