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Search Tolerance Signature in Vascularised Composite Allograft (BIOCTA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02055521
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : July 18, 2014
Sponsor:
Collaborators:
ISTITUTO ITALIANO CHIRURGIA DELLA MANO, Italy
medizinische universität innsbruck, Austria
Hospital Clínico Universitario de Valencia
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment Phase
Hand and Face Allotransplantation Procedure: Blood sample, biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. Phenotype of skin T lymphocyte in cutaneous biopsies [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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France
Hospices Civils de Lyon
Lyon, France, 69003
Sponsors and Collaborators
Hospices Civils de Lyon
ISTITUTO ITALIANO CHIRURGIA DELLA MANO, Italy
medizinische universität innsbruck, Austria
Hospital Clínico Universitario de Valencia

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02055521    
Other Study ID Numbers: 2013.815
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: July 18, 2014
Last Verified: July 2014
Keywords provided by Hospices Civils de Lyon:
Composite tissue allograft
operational tolerance
skin rejection
Hand and Face allotransplantation