Search Tolerance Signature in Vascularised Composite Allograft (BIOCTA)

July 17, 2014 updated by: Hospices Civils de Lyon

Composite tissue allotransplants (CTA) involve transplantation of various tissues including vessels, nerves, skin, bones, and immune cells and entail a significant antigenic load. The large majority of recipients have been maintained on immunosuppression therapy similar to that used in solid organ transplantation that is associated with the complications usually reported in solid organ transplantation. The question whether risks associated with indefinite immunosuppressive are justified for a non-lifesaving procedure still remains unanswered. At present no CTA recipient proved to be spontaneously tolerant with any immunosuppressive protocol; indeed, until now all recipients who discontinued the immunosuppressive therapy rejected their graft. On the other hand CTA recipients showed a low incidence of chronic rejection despite the high incidence of acute rejection episodes.

For all these reasons it should be of great interest to minimize the immunosuppression in CTA patients knowing their immunologic "risk". The main outcome of this study is to search for the signature of tolerance in recipients of hand or face allotransplantation testing biomarkers previously identified in operational tolerant kidney transplant recipients.

These markers have been developed studying tolerant kidney recipients and they were already tested in five bilateral hand transplantations and one face transplantation.

The present study will include hand and face allograft recipients transplanted at least one year in several European institutions (Innsbruck, Lyon, Monza, Valencia): 11 bilateral hand transplantations, 4 single hand transplantations and 3 face transplantations. All the patients will undergo B cell phenotyping, TCR repertoire, molecular signature from operational tolerance and a skin biopsy with immunohistochemical staining of the specimens in order to show signs of acute or chronic rejection.

The results could provide a valid tool to detect operationally tolerant recipients as well as recipients prone to develop chronic rejection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69003
        • Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with Hand (unilateral/bilateral) or face allotransplantation for at least one year
  • Patient without clinical sign of acute rejection at inclusion
  • Patient who signed the informed protocol consent
  • Patient older than 18 years old
  • Patient covered by an health insurance
  • Patient without legal protection

Exclusion Criteria:

  • Patient with Hand or face allotransplantation for less than one year
  • Patient with clinical sign of acute rejection at inclusion
  • Unsigned protocol consent
  • Patient under the age of 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers of molecular signature from operational tolerance and/or chronic rejection research
Time Frame: 1 day
B cell phenotyping, TCR repertoire, molecular signature from operational tolerance
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological characteristics of skin acute/chronic rejection on skin biopsy
Time Frame: 1 day
skin biopsy with immunohistochemical staining of the specimens in order to show signs of acute or chronic rejection. We will try to correlate the signature of tolerance with the absence of chronic rejection symptoms, both clinically and in skin protocol biopsies.
1 day
Phenotype of skin T lymphocyte in cutaneous biopsies
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Collaborators

Hospital Clínico Universitario de Valencia
ISTITUTO ITALIANO CHIRURGIA DELLA MANO, Italy
medizinische universität innsbruck, Austria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

January 17, 2014

First Submitted That Met QC Criteria

February 4, 2014

First Posted (Estimate)

February 5, 2014

Study Record Updates

Last Update Posted (Estimate)

July 18, 2014

Last Update Submitted That Met QC Criteria

July 17, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2013.815

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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