NCT00790257

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2008

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2008

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

March 15, 2018

Status Verified

March 1, 2018

Enrollment Period

6.8 years

First QC Date

November 12, 2008

Last Update Submit

March 13, 2018

Conditions

Type 1 Diabetes Mellitus

Keywords

DiabetesIslets transplantationEncapsulation

Outcome Measures

Primary Outcomes (1)

  • Inflammatory/immunological reaction and insulin production

    2 years

Secondary Outcomes (1)

  • - Encapsulated human islets function and biocompatibility

    2 years

Study Arms (1)

Monolayer Cellular Device

EXPERIMENTAL

Encapsulated human islets allotransplantation transplanted in subcutaneous tissue in Type 1 diabetes patient

Device: Encapsulated human islets in a "Monolayer Cellular Device"

Interventions

Encapsulated human islets in a "Monolayer Cellular Device"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.

Also known as: MCD
Monolayer Cellular Device

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,…);
  • +2 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University clinical Hospital Saint-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Denis Dufrane, MD, PhD

    University clinical hospital Saint-Luc

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2008

First Posted

November 13, 2008

Study Start

November 1, 2008

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

March 15, 2018

Record last verified: 2018-03

Locations

BE(1)