Search Tolerance Signature in Vascularised Composite Allograft

NCT02055521 | Completed

• 1 other identifier: 2013.815
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hand and Face Allotransplantation

Keywords

Composite tissue allograft; operational tolerance; skin rejection; Hand and Face allotransplantation

Outcome Measures

Primary Outcomes (1)

• Biomarkers of molecular signature from operational tolerance and/or chronic rejection research

  B cell phenotyping, TCR repertoire, molecular signature from operational tolerance

  1 day

Secondary Outcomes (2)

• Pathological characteristics of skin acute/chronic rejection on skin biopsy

  1 day

• Phenotype of skin T lymphocyte in cutaneous biopsies

  1 day

Interventions

Blood sample, biopsy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patient with Hand or face allotransplantation for less than one year
• Unsigned protocol consent
• Patient under the age of 18 years old

Sponsors & Collaborators

• Hospices Civils de Lyon: lead
• ISTITUTO ITALIANO CHIRURGIA DELLA MANO, Italy: collaborator
• medizinische universität innsbruck, Austria: collaborator
• Hospital Clínico Universitario de Valencia: collaborator

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69003, France

Location

Related Publications (1)

• Emmanuel Morelon, Sophie BROUARD, Stephan Schneeberger, Anne-Marie Weissenbache. Abstract accepted for presentation at the IHCTAs Congress (Philadelphia, April 2015) and at the ESOT Congress (Brussels, September 2015)."

  BACKGROUND

MeSH Terms

Interventions

Blood Specimen Collection; Biopsy

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2014
• First Posted: February 5, 2014
• Study Start: October 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

FR (1)