Hand and Face AllotransplantationBIOCTANCT02055521
Search Tolerance Signature in Vascularised Composite Allograft
A study testing Blood sample, biopsy in people with Hand and Face Allotransplantation, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Composite tissue allotransplants (CTA) involve transplantation of various tissues including vessels, nerves, skin, bones, and immune cells and entail a significant antigenic load. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand and Face Allotransplantation
- What is being tested?
- Blood sample, biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Blood sample, biopsy
- Keywords
- Composite tissue allograft, operational tolerance, skin rejection, Hand and Face allotransplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample, biopsyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers of molecular signature from operational tolerance and/or chronic rejection research
B cell phenotyping, TCR repertoire, molecular signature from operational tolerance
Measured: 1 day
Secondary outcomes (2)
Pathological characteristics of skin acute/chronic rejection on skin biopsy
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.
Measured: 1 day
Phenotype of skin T lymphocyte in cutaneous biopsies
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startOct 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand and Face AllotransplantationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- ISTITUTO ITALIANO CHIRURGIA DELLA MANO, Italy, medizinische universität innsbruck, Austria, Hospital Clínico Universitario de Valencia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055521
- Sponsor's protocol ID
- 2013.815
- Acronym
- BIOCTA
- Status last verified
- Sep 2025
- First submitted
- 17 Jan 2014
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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)."
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Search Tolerance Signature in Vascularised Composite Allograft
- ClinicalTrials.gov ID
- NCT02055521
- Acronym / sponsor ID
- BIOCTA / 2013.815
- Conditions
- Hand and Face Allotransplantation
- Keywords
- Composite tissue allograft, operational tolerance, skin rejection, Hand and Face allotransplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- ISTITUTO ITALIANO CHIRURGIA DELLA MANO, Italy, medizinische universität innsbruck, Austria, Hospital Clínico Universitario de Valencia
- Study start
- Oct 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 5 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample, biopsy | Procedure or surgery | – |
Primary outcome
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
2 secondary outcomes
Pathological characteristics of skin acute/chronic rejection on skin biopsy
Time frame: 1 day
Phenotype of skin T lymphocyte in cutaneous biopsies
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Results publicationEmmanuel 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)."
Related trials for Hand and Face Allotransplantation
Recruiting
Craniomaxillofacial and Upper Extremity Allotransplantation
Face Injuries, Hand Injuries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample, biopsy in people with Hand and Face Allotransplantation, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers of molecular signature from operational tolerance and/or chronic rejection research (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02055521, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.