Type 1 Diabetes Mellitus Clinical Trial
Official title:
A Monocentre Phase 1 Trial to Assess a Monolayer Cellular Device in the Treatment of Type 1 Diabetes
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" for allogeneic islets transplantation in Type 1 diabetic patients performed
at the University clinical hospital Saint-Luc, Brussels. Encapsulated human islets will be
transplanted in the subcutaneous tissue as "safety procedure" for patients.
This protocol (single center trial) is designed as a limited series of islets transplants for
15 Type 1 diabetic adult subjects.
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 are associated with the administration of standard immunosuppressive agents
(based on use of Sirolimus and Tacrolimus for example) used for human islets
allotransplantation.
The herein presented protocol is a Phase 1 pilot study. This will be a single center clinical
study. Study will be divided in 2 Phases.
- Phase 1A: T1DM patients, already transplanted with an organ (kidney, heart, liver or
totally unfunctioning primary whole vascularized pancreas) and under immunosuppression,
will receive the "Monolayer Cellular Device" in subcutaneous tissue in view to assess
the capacity of encapsulated human islets to secrete insulin without immunological
reaction.
- Phase 1B: T1DM patients will receive the "Monolayer Cellular Device" in subcutaneous
tissue without immunosuppression in view to assess the biocompatibility of the device.
This protocol is designed as a limited series of islets transplants for 15 Type 1 diabetic
adult subjects. In both Pase 1A/1B: Vascularized pancreas transplantation cannot be proposed,
for these patients, following vascular disease, the older age, psychological reasons. Phase
1A consists in the transplantation of encapsulated human islets in Type 1 diabetic patients
already transplanted with primary vascularized organ and under immunosuppression therapy.
Phase 1B consists in the transplantation of encapsulated human islets in Type 1 diabetic
patients who cannot be eligible for whole vascularized pancreas transplantation.
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