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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00790257
First received: November 12, 2008
Last updated: August 12, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Type 1 Diabetes Mellitus
Device: Encapsulated human islets in a "Monolayer Cellular Device"
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • Inflammatory/immunological reaction and insulin production [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • - Encapsulated human islets function and biocompatibility [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: November 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790257

Contacts
Contact: Denis Dufrane, MD, PhD 0032 2 764 67 84 denis.dufrane@uclouvain.be

Locations
Belgium
University clinical Hospital Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Denis Dufrane, MD, PhD    0032 2 764 67 84    denis.dufrane@uclouvain.be   
Principal Investigator: Denis Dufrane, MD, PhD         
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Principal Investigator: Denis Dufrane, MD, PhD University clinical hospital Saint-Luc
  More Information

No publications provided

Responsible Party: Dufrane Denis (MD, PhD), University clinical hospital Saint-Luc, Brussels, Belgium
ClinicalTrials.gov Identifier: NCT00790257     History of Changes
Other Study ID Numbers: UCL-HIA-002
Study First Received: November 12, 2008
Last Updated: August 12, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Diabetes
Islets transplantation
Encapsulation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 28, 2014