Status:
WITHDRAWN
Safety and Efficacy Study of Encapsulated Human Islets Allotransplantation to Treat Type 1 Diabetes
Lead Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
30-80 years
Phase:
PHASE1
Brief Summary
In view to avoid immunosuppression, the investigators are submitting a Phase 1 clinical trial protocol testing the safety and the efficacy of encapsulated human islets in a "Monolayer Cellular Device"...
Detailed Description
The need for chronic immunosuppressive therapy is paralleled by the occurrence of undesirable side effects in islets transplantation as well as whole pancreas transplantation. Several complications ar...
Eligibility Criteria
Inclusion
- Phase 1A:
- Male or female patients, of 30 to 80 years of age, C-peptide-negative;
- Patient must have signed the Patient Informed Consent Form;
- Type 1 diabetic (T1DM) patients insulin-dependent;
- T1DM patients already transplanted with a kidney graft and already on immunosuppressive therapy;
- T1DM patients already transplanted with a vascularized pancreas, already on immunosuppressive therapy, but with TOTAL dysfunction of the graft;
- T1DM patients already transplanted with a liver graft and already on immunosuppressive therapy;
- T1DM patients already transplanted with a heart or lung graft and already on immunosuppressive therapy;
- T1DM patients eligible for simultaneous transplantation with kidney and encapsulated human islets;
- Donor-Recipient ABO blood group compatibility;
- Donor- Recipient HLA compatibility.
- Phase 1B:
- Male or female patients, of 30 to 80 years of age, C-peptide-negative;
- Patient must have signed the Patient Informed Consent Form;
- T1DM patients without any immunosuppression who cannot be transplanted with vascularized pancreas (vascular complication, psychological reasons,...). The main objective is to restore a residual insulin secretion to stabilize the diabetes (reduction of hypoglycaemia,…);
- Donor-Recipient ABO blood group compatibility;
- Donor- Recipient HLA compatibility.
Exclusion
- RECIPIENT EXCLUSION CRITERIA FOR PHASE 1A/B:
- Patient is pregnant or breastfeeding.
- Patient has a positive T-cell crossmatch on the most recent serum specimen.
- Patient has malignancy or history of malignancy, with the exception of adequately treated localised squamous cell or basal cell carcinoma, without recurrence.
- Patient has been included in another clinical trial protocol for any investigational drug within 4 weeks prior inclusion in UCL-HIA-002.
- Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00790257
Start Date
November 1 2008
End Date
September 1 2015
Last Update
March 15 2018
Active Locations (1)
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1
University clinical Hospital Saint-Luc
Brussels, Belgium, 1200