Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-28 @ 5:30 AM
Study NCT ID:
NCT00790257
Status:
WITHDRAWN
Last Update Posted:
2018-03-15
First Post:
2008-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Encapsulated Human Islets Allotransplantation to Treat Type 1 Diabetes
Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Organization:
Study Overview
Official Title:
A Monocentre Phase 1 Trial to Assess a Monolayer Cellular Device in the Treatment of Type 1 Diabetes
Status:
WITHDRAWN
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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" 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.
This protocol (single center trial) is designed as a limited series of islets transplants for 15 Type 1 diabetic adult subjects.
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 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: