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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Universitair Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB, Brussels, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

islet cell grafts

Procedure

Intraportal injection of an islet cell graft into the liver.

Primary outcomes

Evidence of clinically relevant beta cell function.

Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Collaborators

Erasme University Hospital
Universitaire Ziekenhuizen KU Leuven
Universiteit Antwerpen
Vrije Universiteit Brussel

Registry information

Important dates

Study start: 2000
Primary completion: 2005
Study completion: 2005
First posted: Feb 26, 2008
Registry last updated: Feb 26, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed