Surgery, OralAFTCNCT02818400
Composite Tissue Allotransplantation of the Face: Anatomical and Functional Evaluation
A study testing composite tissue allotransplantation in people with Surgery, Oral, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
In hindsight, the first "face graft" raises the fundamental problem of composite tissue allotransplantation (hand, larynx, abdominal wall, etc.) with the addition of specific technical and philosophical problems. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Surgery, Oral
- What is being tested?
- composite tissue allotransplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2009to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with loss of unrepairable substance by conventional techniques shreds, at the front
Who cannot join
- Facial lesions repaired by conventional reconstructive surgery techniques
- History of malignancy in remission for less than 5 years
- Malignant neoplasm undergoing changes
- Severe psychiatric history
- Patients above a score of 2 on the scale of the ASA (American Society of Anesthesiology)
- Patients above a grade 1 in the classification NYHA ( New York Heart Association )
- insufficient with renal creatinine clearance less than 70 mL / min or presence of a proteinuria
- Severe hypertension
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80054
Bernard DEVAUCHELLE, MD, PhD, +33 3 22 08 90 71, devauchelle.bernard@chu-amiens.fr
About this study
In hindsight, the first "face graft" raises the fundamental problem of composite tissue allotransplantation (hand, larynx, abdominal wall, etc.) with the addition of specific technical and philosophical problems.
By proposing a prospective study concerning five new patients over the next three years, in the light of this first experience, the authors would like to confirm the surgical feasibility of this type of procedure, possibly extending it to other parts of the face (lateral third) and, like English and American teams, considering the possibility of total facial surface reconstruction.
Read more
In parallel, and while complying with the usual immunosuppression procedures, the deliberate choice of creating a microchimerism by the infusion of bone marrow stem cells (the origin and quantity of which will need to be determined) will be reaffirmed, in order to improve mucocutaneous tissue tolerance, while confirming the safety of this type of approach.
Five new cases will also provide observations for the many new fields of research developing around composite tissue transplants (neurophysiology, skin histopathology, psychiatry, haematology, immunology, etc.).
- Conditions
- Surgery, Oral
- Being tested
- composite tissue allotransplantation
- Keywords
- maxillofacial surgery, face graft, composite tissue, stem cell infusion, allotransplantation, microsurgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
composite tissue allotransplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Composite tissue allotransplantation | Experimental | Not described Receives: Procedure: composite tissue allotransplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional recovery : motor recovery
labial contact allowing complete mouth closure
Measured: 1 year
functional recovery : sensory recovery
Sensitivity to light touch, as assessed with the use of static monofilaments
Measured: 1 year
functional recovery : sensory recovery
sensitivity to heat and cold
Measured: 1 year
Secondary outcomes (3)
functional recovery : motor recovery
labial contact allowing complete mouth closure
Measured: 2 years, 5 years
functional recovery : sensory recovery
Sensitivity to light touch, as assessed with the use of static monofilaments
Measured: 2 years, 5 years
functional recovery : sensory recovery
sensitivity to heat and cold
Measured: 2 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startNov 2009
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery, OralStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard DEVAUCHELLE, Md, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818400
- Sponsor's protocol ID
- PHRCN06-PR-DEVAUCHELLE
- Acronym
- AFTC
- Status last verified
- May 2026
- First submitted
- 10 Jun 2016
- Last updated
- 13 May 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Composite Tissue Allotransplantation of the Face: Anatomical and Functional Evaluation
- ClinicalTrials.gov ID
- NCT02818400
- Acronym / sponsor ID
- AFTC / PHRCN06-PR-DEVAUCHELLE
- Conditions
- Surgery, Oral
- Keywords
- maxillofacial surgery, face graft, composite tissue, stem cell infusion, allotransplantation, microsurgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Nov 2009 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Jun 2016 (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.
In hindsight, the first "face graft" raises the fundamental problem of composite tissue allotransplantation (hand, larynx, abdominal wall, etc.) with the addition of specific technical and philosophical problems.
By proposing a prospective study concerning five new patients over the next three years, in the light of this first experience, the authors would like to confirm the surgical feasibility of this type of procedure, possibly extending it to other parts of the face (lateral third) and, like English and American teams, considering the possibility of total facial surface reconstruction.
In parallel, and while complying with the usual immunosuppression procedures, the deliberate choice of creating a microchimerism by the infusion of bone marrow stem cells (the origin and quantity of which will need to be determined) will be reaffirmed, in order to improve mucocutaneous tissue tolerance, while confirming the safety of this type of approach.
Five new cases will also provide observations for the many new fields of research developing around composite tissue transplants (neurophysiology, skin histopathology, psychiatry, haematology, immunology, etc.).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Composite tissue allotransplantation | Experimental | Procedure: composite tissue allotransplantation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with loss of unrepairable substance by conventional techniques shreds, at the front
Key exclusion criteria (8 listed)
- Facial lesions repaired by conventional reconstructive surgery techniques
- History of malignancy in remission for less than 5 years
- Malignant neoplasm undergoing changes
- Severe psychiatric history
- Patients above a score of 2 on the scale of the ASA (American Society of Anesthesiology)
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 |
|---|---|---|
| composite tissue allotransplantation | Procedure or surgery | Composite tissue allotransplantation |
Primary outcome
functional recovery : motor recovery
Time frame: 1 year
labial contact allowing complete mouth closure
functional recovery : sensory recovery
Time frame: 1 year
Sensitivity to light touch, as assessed with the use of static monofilaments
functional recovery : sensory recovery
Time frame: 1 year
sensitivity to heat and cold
3 secondary outcomes
functional recovery : motor recovery
Time frame: 2 years, 5 years
functional recovery : sensory recovery
Time frame: 2 years, 5 years
functional recovery : sensory recovery
Time frame: 2 years, 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
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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.
Bernard DEVAUCHELLE, Md, PhD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing composite tissue allotransplantation in people with Surgery, Oral, run by Centre Hospitalier Universitaire, Amiens 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 1 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 13 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bernard DEVAUCHELLE, Md, PhD (+33 3 22 08 90 71, devauchelle.bernard@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional recovery : motor recovery (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2026.