Clinical trial NCT02055521: Search Tolerance Signature in Vascularised Composite Allograft
Official title: Search Tolerance Signature in Vascularised Composite Allograft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand and Face Allotransplantation
Keywords: Composite tissue allograft
operational tolerance
skin rejection
Hand and Face allotransplantation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: ISTITUTO ITALIANO CHIRURGIA DELLA MANO, Italy
name: medizinische universität innsbruck, Austria
name: Hospital Clínico Universitario de Valencia
First posted: 2014-02-05
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Biomarkers of molecular signature from operational tolerance and/or chronic rejection research
timeFrame: 1 day
Secondary outcomes:
measure: Pathological characteristics of skin acute/chronic rejection on skin biopsy
timeFrame: 1 day
measure: Phenotype of skin T lymphocyte in cutaneous biopsies
timeFrame: 1 day
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
References: