Reconstruction of the FacePhase 2NCT00527280
Face Reconstruction by Allotransplantation of Composite Tissues
A Phase 2 study testing Feasibility ot face transplantation in people with Reconstruction of the Face, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
To show the feasibility of face transplantation in patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Reconstruction of the Face
- What is being tested?
- Feasibility ot face transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2007to May 2016
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 through 65 years
- Signed written informed consent
- patient with a loss of substance of the median third of the face by traumatisms or not carrying the totality of the lips with or without the nasal pyramid.
- validation of the feasibility by a committee of expert in plastic surgery and maxillofacial
- patient with a positive psychologic evaluation
- patient with an anatomical evaluation and assessment pretransplantation positive normal infectious assessment
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- Good compliance and capacity of adaptation to the assessment difficulties
- Patient with renal, hepatic, hematologic ,cardiac normal
- Patient profiting from a Social Security cover
- Patient informed patient, having signed a free assent lit with inclusion in the study
Who cannot join
- patient minor under supervision or deprived of freedom by court order or administrative.
- person remaining in a medical or social establishment
- pregnant. or breast-feeding women
- patient presenting a sever cardiac pathology having a risk of decompensation into pre, per and post operational
- patient presenting a hepatic pathology
- Any cancer that has been in complete remission for > 5 years malignancies tumoral lesion of the face with 2 years deadline of remission respected renal insufficiency chronic clearance of creatin < 60l ml/mn
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- chronic respiratory insufficiency
- patient presenting an active infection which can be worsened by the immunosuppression
- patient presenting an active infection which can be worsened by the corticoid
- patient with affection being able to compromise post-operative survival
- patient with digestive ulcer
- No known HIV infection
- serology hepatitis B with circulating DNA highlighted quantitatively
- personality emotional unstable
- schizophrenic or not schizophrenic psychosis
Trial locations and contacts
1 site in 1 country.
About this study
To show the feasibility of face transplantation in patients
Read the detailed description
Most facial defects can be reconstructed with autologous tissues using standard plastic surgical techniques. However, when the circular facial muscles (eg. orbicularis oculi and orbicularis oris) are destroyed by burns, ballistic traumas, tumors, or congenital deformities there are no conventional surgical solutions. The study was designed following the advice of the French National Ethics Advisory Committee for life sciences and health (CCNE). The objectives are to study the feasibility and efficacy of face CTA transplantation, functional results, and influence on quality-of-life, as well as the management of immunosuppression.
- Conditions
- Reconstruction of the Face
- Being tested
- Feasibility ot face transplantation
- Keywords
- Allotransplantation:composite tissue, Face transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feasibility ot face transplantationProcedure or surgery
Feasibility ot face transplantation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Procedure: Feasibility ot face transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reconstruction tissular at carrier patients of a loss of substance of the median third(third party) of the face having taken the totality of lips with or without the nasal pyramid; or of a loss of substance taking the totality of 4 eyelids.
Measured: during the study
Secondary outcomes (4)
To evaluate the potential benefit of such a transplantation in term of quality of life
Measured: during the study
To measure the impact of this improvement
Measured: during the study
To measure the impact of a immunosuppressive treatment for a pathology which is not vital
Measured: during the study
To evaluate Acute Graft rejection using skin and mucosa biopsies: function of the lips and or eyelids mobility and function of the orbicularis muscles Quality of life the psychiatric and psychological evaluations
Measured: at in the following days weeks and month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startJan 2007
- Primary completionMay 2016
- Study completionMay 2016
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 Reconstruction of the FaceStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent LANTIERI, MD PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527280
- Sponsor's protocol ID
- P050303
- Status last verified
- Mar 2017
- First submitted
- 5 Sep 2007
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lantieri L, Grimbert P, Ortonne N, Suberbielle C, Bories D, Gil-Vernet S, Lemogne C, Bellivier F, Lefaucheur JP, Schaffer N, Martin F, Meningaud JP, Wolkenstein P, Hivelin M. Face transplant: long-term follow-up and results of a prospective open study. Lancet. 2016 Oct 1;388(10052):1398-1407. doi: 10.1016/S0140-6736(16)31138-2. Epub 2016 Aug 25.
PubMed 27567680
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Face Reconstruction by Allotransplantation of Composite Tissues
- ClinicalTrials.gov ID
- NCT00527280
- Acronym / sponsor ID
- P050303
- Conditions
- Reconstruction of the Face
- Keywords
- Allotransplantation:composite tissue, Face transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 10 Sep 2007 (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.
To show the feasibility of face transplantation in patients
Detailed description
Most facial defects can be reconstructed with autologous tissues using standard plastic surgical techniques. However, when the circular facial muscles (eg. orbicularis oculi and orbicularis oris) are destroyed by burns, ballistic traumas, tumors, or congenital deformities there are no conventional surgical solutions. The study was designed following the advice of the French National Ethics Advisory Committee for life sciences and health (CCNE). The objectives are to study the feasibility and efficacy of face CTA transplantation, functional results, and influence on quality-of-life, as well as the management of immunosuppression.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Feasibility ot face transplantation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 through 65 years
- Signed written informed consent
- patient with a loss of substance of the median third of the face by traumatisms or not carrying the totality of the lips with or without the nasal pyramid.
- validation of the feasibility by a committee of expert in plastic surgery and maxillofacial
- patient with a positive psychologic evaluation
Key exclusion criteria (15 listed)
- patient minor under supervision or deprived of freedom by court order or administrative.
- person remaining in a medical or social establishment
- pregnant. or breast-feeding women
- patient presenting a sever cardiac pathology having a risk of decompensation into pre, per and post operational
- patient presenting a hepatic pathology
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 |
|---|---|---|
| Feasibility ot face transplantationFeasibility ot face transplantation | Procedure or surgery | 1 |
Primary outcome
Reconstruction tissular at carrier patients of a loss of substance of the median third(third party) of the face having taken the totality of lips with or without the nasal pyramid; or of a loss of substance taking the totality of 4 eyelids.
Time frame: during the study
4 secondary outcomes
To evaluate the potential benefit of such a transplantation in term of quality of life
Time frame: during the study
To measure the impact of this improvement
Time frame: during the study
To measure the impact of a immunosuppressive treatment for a pathology which is not vital
Time frame: during the study
To evaluate Acute Graft rejection using skin and mucosa biopsies: function of the lips and or eyelids mobility and function of the orbicularis muscles Quality of life the psychiatric and psychological evaluations
Time frame: at in the following days weeks and month after surgery
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 22 Mar 2017.
- Derived from this study: PubMed 27567680Lantieri L, Grimbert P, Ortonne N, Suberbielle C, Bories D, Gil-Vernet S, Lemogne C, Bellivier F, Lefaucheur JP, Schaffer N, Martin F, Meningaud JP, Wolkenstein P, Hivelin M. Face transplant: long-term follow-up and results of a prospective open study. Lancet. 2016 Oct 1;388(10052):1398-1407. doi: 10.1016/S0140-6736(16)31138-2. Epub 2016 Aug 25.
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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. This study is not recruiting at the moment.
Laurent LANTIERI, MD PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Feasibility ot face transplantation in people with Reconstruction of the Face, run by Assistance Publique - Hôpitaux de Paris 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 10 inclusion and 15 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 22 Mar 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reconstruction tissular at carrier patients of a loss of substance of the median third(third party) of the face having taken the totality of lips with or without the nasal pyramid; or of a loss of substance taking the totality of 4 eyelids. (time frame: during the study). 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 NCT00527280, 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 22 Mar 2017.