Search Tolerance Signature in Vascularised Composite Allograft

NCT ID: NCT02055521

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-07-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Blood sample, biopsy

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ISTITUTO ITALIANO CHIRURGIA DELLA MANO, Italy

UNKNOWN

Sponsor Role: collaborator

medizinische universität innsbruck, Austria

UNKNOWN

Sponsor Role: collaborator

Hospital Clínico Universitario de Valencia

OTHER

Sponsor Role: collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospices Civils de Lyon

Lyon, , France

Countries

France

References

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)."

Reference Type: BACKGROUND

Other Identifiers

2013.815

Identifier Type: -

Identifier Source: org_study_id