Safety and Efficacy Study of Encapsulated Human Islets Allotransplantation to Treat Type 1 Diabetes

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00790257
Collaborator
(none)
0
1
1
82
0

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Encapsulated human islets in a "Monolayer Cellular Device"
Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Nov 1, 2008
Actual Primary Completion Date :
Sep 1, 2015
Actual Study Completion Date :
Sep 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • MCD
  • Outcome Measures

    Primary Outcome Measures

    1. Inflammatory/immunological reaction and insulin production [2 years]

    Secondary Outcome Measures

    1. - Encapsulated human islets function and biocompatibility [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Phase 1A:
    1. Male or female patients, of 30 to 80 years of age, C-peptide-negative;

    2. Patient must have signed the Patient Informed Consent Form;

    3. Type 1 diabetic (T1DM) patients insulin-dependent;

    4. T1DM patients already transplanted with a kidney graft and already on immunosuppressive therapy;

    5. T1DM patients already transplanted with a vascularized pancreas, already on immunosuppressive therapy, but with TOTAL dysfunction of the graft;

    6. T1DM patients already transplanted with a liver graft and already on immunosuppressive therapy;

    7. T1DM patients already transplanted with a heart or lung graft and already on immunosuppressive therapy;

    8. T1DM patients eligible for simultaneous transplantation with kidney and encapsulated human islets;

    9. Donor-Recipient ABO blood group compatibility;

    10. Donor- Recipient HLA compatibility.

    • Phase 1B:
    1. Male or female patients, of 30 to 80 years of age, C-peptide-negative;

    2. Patient must have signed the Patient Informed Consent Form;

    3. 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,…);

    4. Donor-Recipient ABO blood group compatibility;

    5. Donor- Recipient HLA compatibility.

    Exclusion Criteria:
    • RECIPIENT EXCLUSION CRITERIA FOR PHASE 1A/B:
    1. Patient is pregnant or breastfeeding.

    2. Patient has a positive T-cell crossmatch on the most recent serum specimen.

    3. Patient has malignancy or history of malignancy, with the exception of adequately treated localised squamous cell or basal cell carcinoma, without recurrence.

    4. Patient has been included in another clinical trial protocol for any investigational drug within 4 weeks prior inclusion in UCL-HIA-002.

    5. Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University clinical Hospital Saint-Luc Brussels Belgium 1200

    Sponsors and Collaborators

    • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    Investigators

    • Principal Investigator: Denis Dufrane, MD, PhD, University clinical hospital Saint-Luc

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cliniques universitaires Saint-Luc- Université Catholique de Louvain
    ClinicalTrials.gov Identifier:
    NCT00790257
    Other Study ID Numbers:
    • UCL-HIA-002
    First Posted:
    Nov 13, 2008
    Last Update Posted:
    Mar 15, 2018
    Last Verified:
    Mar 1, 2018
    Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 15, 2018