Beta-Cell Transplantation in Pre-Uremic Patients With Type 1 Diabetes
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ClinicalTrials.gov Identifier: NCT00623610 |
Recruitment Status
:
Completed
First Posted
: February 26, 2008
Last Update Posted
: February 26, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 1 | Procedure: islet cell grafts | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Beta-Cell Transplantation in Pre-Uremic Patients With Type 1 Diabetes |
Study Start Date : | September 2000 |
Actual Primary Completion Date : | October 2005 |
Actual Study Completion Date : | October 2005 |

-
Procedure: islet cell grafts
- Evidence of clinically relevant beta cell function. [ Time Frame: 2 years ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00623610
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 |
Principal Investigator: | Bart Keymeulen, MD, PhD | Universitair Ziekenhuis Brussel |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Bart Keymeulen, Universitair Ziekenhuis Brussel |
ClinicalTrials.gov Identifier: | NCT00623610 History of Changes |
Other Study ID Numbers: |
BK-Tx-04 |
First Posted: | February 26, 2008 Key Record Dates |
Last Update Posted: | February 26, 2008 |
Last Verified: | February 2008 |
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 |