Search Tolerance Signature in Vascularised Composite Allograft (BIOCTA)
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|ClinicalTrials.gov Identifier: NCT02055521|
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : July 18, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Hand and Face Allotransplantation||Procedure: Blood sample, biopsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Search Tolerance Signature in Vascularised Composite Allograft|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
- 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
- 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.
- Phenotype of skin T lymphocyte in cutaneous biopsies [ Time Frame: 1 day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055521
|Hospices Civils de Lyon|
|Lyon, France, 69003|