Safety and Efficacy Study of Encapsulated Human Islets Allotransplantation to Treat 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.
|Type 1 Diabetes Mellitus||Device: Encapsulated human islets in a "Monolayer Cellular Device"||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Monocentre Phase 1 Trial to Assess a Monolayer Cellular Device in the Treatment of Type 1 Diabetes|
- Inflammatory/immunological reaction and insulin production [ Time Frame: 2 years ]
- - Encapsulated human islets function and biocompatibility [ Time Frame: 2 years ]
|Study Start Date:||November 2008|
|Study Completion Date:||September 2015|
|Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Experimental: Monolayer Cellular Device
Encapsulated human islets allotransplantation transplanted in subcutaneous tissue in Type 1 diabetes patient
Device: Encapsulated human islets in a "Monolayer Cellular Device"
The product consists of isolated allogeneic human islets of Langerhans formulated in a serum-free transplant media. The islets will be encapsulated in an alginate-based "Monolayer Cellular Device".
One device will be transplanted subcutaneously and corresponds to a patch of 1-3cm². One Device per patient. No Retransplantation.
Other Name: MCD
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00790257
|University clinical Hospital Saint-Luc|
|Brussels, Belgium, 1200|
|Principal Investigator:||Denis Dufrane, MD, PhD||University clinical hospital Saint-Luc|