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Bet Cell Therapy in Diabetes Type 1

NCT01379729 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2013-12-30

No results posted yet for this study

Summary

Primary outcome measurement is a parameter of functional beta cell mass at 6 months PT. Functional beta-cell mass will be calculated using the AUC/min between 150 and 160 min during hyperglycemic clamp at 180 mg/dl.

The investigators hypothesize that functional beta-cell mass will be more than 20% compared to healthy controls.

Secondary outcome measurements:

Functional beta-cell mass at 2,12,18,24,36,48 and 60 months PT.

The investigators will also compare at 2, 6,12, 24,36,48 and 60 months the changes against base-line (base-line = before first intraperitoneal transplantation):

* metabolic control
* safety parameters
* episodes of hypoglycemia
* islet cell autoantibodies, lymphocyte subsets, T-cell reactivity against auto- and alloantigens using pre-transplant measurements as base-line The investigators hypothesize that metabolic control and prevalence of hypoglycemia, will be significantly improved till PT month 12.

Histopathology of a biopsy specimen of the human intraperitoneal beta cell implant, at time of the second implant. Comparison with composition of graft, identification of microenvironment of host origin and correlation with functional assessment will be performed.

Conditions

Interventions

OTHER

Transplantation of encapsulated beta cells.

Implantation of a therapeutical dose of encapsulated beta cells.

OTHER

Transplantation of encapsulated beta cells.

Implantation of a therapeutical dose of encapsulated beta cells.

Sponsors & Collaborators

  • Universitair Ziekenhuis Brussel

    collaborator OTHER

  • Universitaire Ziekenhuizen KU Leuven

    collaborator OTHER

  • AZ-VUB

    lead OTHER

Principal Investigators

  • Bart Keymeulen, MD PhD · Universitair Ziekenhuis Brussel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-12-31
Completion
2018-05-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01379729 on ClinicalTrials.gov