Back to resultsSafety and Efficacy Study of Encapsulated Human Islets Allotransplantation to Treat Type 1 Diabetes
Primary Purpose
Type 1 Diabetes Mellitus
Status
Withdrawn
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
Encapsulated human islets in a "Monolayer Cellular Device"
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Diabetes, Islets transplantation, Encapsulation
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Sites / Locations
- University clinical Hospital Saint-Luc
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Monolayer Cellular Device
Arm Description
Encapsulated human islets allotransplantation transplanted in subcutaneous tissue in Type 1 diabetes patient
Outcomes
Primary Outcome Measures
Inflammatory/immunological reaction and insulin production
Secondary Outcome Measures
- Encapsulated human islets function and biocompatibility
Full Information
NCT ID
NCT00790257
First Posted
November 12, 2008
Last Updated
March 13, 2018
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT00790257
Brief Title
Safety and Efficacy Study of Encapsulated Human Islets Allotransplantation to Treat Type 1 Diabetes
Official Title
A Monocentre Phase 1 Trial to Assess a Monolayer Cellular Device in the Treatment of Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Withdrawn
Study Start Date
November 2008 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Diabetes, Islets transplantation, Encapsulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Monolayer Cellular Device
Arm Type
Experimental
Arm Description
Encapsulated human islets allotransplantation transplanted in subcutaneous tissue in Type 1 diabetes patient
Intervention Type
Device
Intervention Name(s)
Encapsulated human islets in a "Monolayer Cellular Device"
Other Intervention Name(s)
MCD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Inflammatory/immunological reaction and insulin production
Time Frame
2 years
Secondary Outcome Measure Information:
Title
- Encapsulated human islets function and biocompatibility
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis Dufrane, MD, PhD
Organizational Affiliation
University clinical hospital Saint-Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
University clinical Hospital Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of Encapsulated Human Islets Allotransplantation to Treat Type 1 Diabetes
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