Facial TraumaNCT05699187
Face Transplantation
A study testing Face allotransplantation in people with Facial Trauma and Facial Deformity, run by Massachusetts General Hospital.
Trial summary
Face allotransplantation will be performed in facial trauma patients. Immune suppression will primarily be provided according to standard three-drug regimen. The primary outcome to be evaluated in the proposed trial is face allograft acceptance. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Facial Trauma, Facial Deformity, Facial Injuries
- What is being tested?
- Face allotransplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Aug 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recent (≥6 months) or remote (i.e., several decades) severe facial disfigurement and/or facial functional impairment covering at least 25% of face and/or a major part e.g. nose, lips and desiring face transplantation.
- Aged 18-65 years. Noted should be that the maximal age difference between donor and recipient will be 10 years.
- Completion of the protocol informed consent form.
- No co-existing medical condition which, in the opinion of the study team, could affect the immunomodulatory protocol, surgical procedure, or functional results (see Donor and Recipient Exclusion Criteria below. If the condition is amenable to treatment, the study team must agree that said condition should not significantly enhance the surgical risks of facial transplantation.)
- No co-existing psycho-social problems (i.e., alcoholism, drug abuse).
- Negative for malignancy for past 5 years.
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- Negative for HIV at transplant.
- Negative crossmatch with donor.
- If female of child-bearing potential, negative serum pregnancy test. If female of child-bearing potential, consent to use reliable contraception for at least one year following transplantation.
- Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regimen.
- No smoking for 6 months prior to transplant, as confirmed by blood testing.
Who cannot join
- Positive for any of the following conditions: Untreated sepsis, HIV (active or seropositive), active tuberculosis, hepatitis B or C (HCV Ab+ and HCV RNA+ (HCV Ab+ but RNA negative is acceptable), HBVcAb+, HBVsAg+ or viral DNA+), viral encephalitis, toxoplasmosis, malignancy (within past 5 years), current/recent (within months of donation/consent) IV drug abuse, paralysis of ischemic or traumatic origin, inherited peripheral neuropathy, infectious, post infectious, or inflammatory (axonal or demyelinating) neuropathy, toxic neuropathy (i.e. heavy metal poisoning, drug toxicity, industrial agent exposure), mixed connective tissue disease, severe deforming rheumatoid or osteoarthritis in the limb.
- Conditions that, in the opinion of the study team, may impact the immunomodulatory protocol potentially exposing the recipient to an unacceptable risk under immunosuppressive treatment, including all liver and renal disease.
- Sensitized recipients with high levels (>=50%) of panel-reactive HLA antibodies.
- Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications including inherited coagulopathies like Hemophilia, Von-Willebrand's disease, Protein C and S deficiency, Thrombocythemias, Thalassemias, Sickle Cell disease, etc.
- Mixed connective tissue diseases and collagen diseases can result in poor wound healing after surgery.
- Conditions that may impact functional outcomes including lipopolysaccharidosis and amyloidosis (may impact nerve regeneration) or rare disorders of bone healing like osteopetrosis.
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- Pregnant, breastfeeding or planning to become pregnant within the next 2 years.
- Unable or unwilling to use an acceptable birth control method for 2 years following transplant. The patient cannot have given birth in the past 2 years. We acknowledge that a female recipient of childbearing age must carefully consider the associated risks of the transplant and immunosuppression and personally prioritize these issues and the lead face transplant surgeon (Dr. Cetrulo) will implement this subject in the preoperative education of the patient during consultation.
- Patients will be required to stop smoking for 6 months prior to listing and abstain from postoperative smoking
- If a subject does not receive a transplant after one year of enrollment, clinical consent will be re-obtained from that subject and clinical consent will be re-obtained yearly while the subject is enrolled and waiting for a donor.
About this study
Face allotransplantation will be performed in facial trauma patients. Immune suppression will primarily be provided according to standard three-drug regimen. The primary outcome to be evaluated in the proposed trial is face allograft acceptance.
Read the detailed description
Patients with severe facial disfigurement referred or self-identified to the MGH Face Transplantation Program will undergo a consultation with the PI (Dr. Cetrulo) who will perform a thorough clinical assessment and explain in detail the treatment protocol, risks and benefits of the face allotransplantation procedure and alternative options. At the time of appointment, candidates will be first requested to sign a face transplant Research Informed Consent form . Following the signing of these documents, the candidate will meet with the MGH Transplant Center team (see below for description of entire team), a clinical pharmacist, dietician, and a transplant social worker.
Appropriate subjects will then undergo further evaluation/medical screening procedures to determine their candidacy for face transplantation. Prospective recipients who are selected based on results of screening procedures will be invited to review and sign the full informed consent form prior to being wait-listed for the procedure.
There is a significant evaluation using tests, procedures, consults, and evaluations that will be performed as part of the standard of care for those clinically-approved for organ transplantation.
- Conditions
- Facial Trauma, Facial Deformity, Facial Injuries
- Being tested
- Face allotransplantation
- Keywords
- Transplant, Face Transplant
- Medical subject headings
- Facial Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face allotransplantationProcedure or surgery
Facial allotransplantation
| Study group | Role | What they receive |
|---|---|---|
| Face Transplant Recipient | Experimental | The procedure will be carried out simultaneously by two teams of transplant surgeons for each face transplanted in the operation. The teams will be divided between the functions of tissue recovery (donor operation) and transplant surgery (recipient operation). In most cases the facial graft will include the entire nose; the soft tissues of the mid-face, including all its blood vessels, muscles, and nerves; and a significant portion of the mid-facial skeleton. Receives: Procedure: Face allotransplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of motor function of face
Function of face as assessed by ability to move face, smile, frown, etc.
Measured: 1 Year
Incidence of intact sensation of face
Sensation of face intact using standard methods (sharp vs dull, presence of numbness)
Measured: 1 Year
Incidence of an ascetically satisfactory appearing face
Evaluated by overall appearance, symmetry
Measured: 1 Year
Incidence of a cost benefit to facial transplant
This will be assessed by standard treatment of facial disfigured patients vs face transplant
Measured: 1 Year
Secondary outcomes (1)
Incidence of rejection episodes on triple therapy immunosuppression
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Aug 2024
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Why it stopped: No enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial TraumaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Curtis L. Cetrulo, MD, Massachusetts General Hospital
- Investigators
- Curt Cetrulo, MD, FACS, FAAP, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699187
- Sponsor's protocol ID
- 2021P002531
- Status last verified
- Nov 2024
- First submitted
- 12 Jan 2023
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Face Transplantation
- ClinicalTrials.gov ID
- NCT05699187
- Acronym / sponsor ID
- 2021P002531
- Conditions
- Facial Trauma, Facial Deformity, Facial Injuries
- Keywords
- Transplant, Face Transplant
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 26 Jan 2023 (actual)
- 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.
Face allotransplantation will be performed in facial trauma patients. Immune suppression will primarily be provided according to standard three-drug regimen. The primary outcome to be evaluated in the proposed trial is face allograft acceptance.
Detailed description
Patients with severe facial disfigurement referred or self-identified to the MGH Face Transplantation Program will undergo a consultation with the PI (Dr. Cetrulo) who will perform a thorough clinical assessment and explain in detail the treatment protocol, risks and benefits of the face allotransplantation procedure and alternative options. At the time of appointment, candidates will be first requested to sign a face transplant Research Informed Consent form . Following the signing of these documents, the candidate will meet with the MGH Transplant Center team (see below for description of entire team), a clinical pharmacist, dietician, and a transplant social worker.
Appropriate subjects will then undergo further evaluation/medical screening procedures to determine their candidacy for face transplantation. Prospective recipients who are selected based on results of screening procedures will be invited to review and sign the full informed consent form prior to being wait-listed for the procedure.
There is a significant evaluation using tests, procedures, consults, and evaluations that will be performed as part of the standard of care for those clinically-approved for organ transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Face Transplant Recipient | Experimental | Procedure: Face allotransplantationThe procedure will be carried out simultaneously by two teams of transplant surgeons for each face transplanted in the operation. The teams will be divided between the functions of tissue recovery (donor operation) and transplant surgery (recipient operation). In most cases the facial graft will include the entire nose; the soft tissues of the mid-face, including all its blood vessels, muscles, and nerves; and a significant portion of the mid-facial skeleton. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Recent (≥6 months) or remote (i.e., several decades) severe facial disfigurement and/or facial functional impairment covering at least 25% of face and/or a major part e.g. nose, lips and desiring face transplantation.
- Aged 18-65 years. Noted should be that the maximal age difference between donor and recipient will be 10 years.
- Completion of the protocol informed consent form.
- No co-existing medical condition which, in the opinion of the study team, could affect the immunomodulatory protocol, surgical procedure, or functional results (see Donor and Recipient Exclusion Criteria below. If the condition is amenable to treatment, the study team must agree that said condition should not significantly enhance the surgical risks of facial transplantation.)
- No co-existing psycho-social problems (i.e., alcoholism, drug abuse).
Key exclusion criteria (10 listed)
- Positive for any of the following conditions: Untreated sepsis, HIV (active or seropositive), active tuberculosis, hepatitis B or C (HCV Ab+ and HCV RNA+ (HCV Ab+ but RNA negative is acceptable), HBVcAb+, HBVsAg+ or viral DNA+), viral encephalitis, toxoplasmosis, malignancy (within past 5 years), current/recent (within months of donation/consent) IV drug abuse, paralysis of ischemic or traumatic origin, inherited peripheral neuropathy, infectious, post infectious, or inflammatory (axonal or demyelinating) neuropathy, toxic neuropathy (i.e. heavy metal poisoning, drug toxicity, industrial agent exposure), mixed connective tissue disease, severe deforming rheumatoid or osteoarthritis in the limb.
- Conditions that, in the opinion of the study team, may impact the immunomodulatory protocol potentially exposing the recipient to an unacceptable risk under immunosuppressive treatment, including all liver and renal disease.
- Sensitized recipients with high levels (>=50%) of panel-reactive HLA antibodies.
- Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications including inherited coagulopathies like Hemophilia, Von-Willebrand's disease, Protein C and S deficiency, Thrombocythemias, Thalassemias, Sickle Cell disease, etc.
- Mixed connective tissue diseases and collagen diseases can result in poor wound healing after surgery.
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 |
|---|---|---|
| Face allotransplantationFacial allotransplantation | Procedure or surgery | Face Transplant Recipient |
Primary outcome
Incidence of motor function of face
Time frame: 1 Year
Function of face as assessed by ability to move face, smile, frown, etc.
Incidence of intact sensation of face
Time frame: 1 Year
Sensation of face intact using standard methods (sharp vs dull, presence of numbness)
Incidence of an ascetically satisfactory appearing face
Time frame: 1 Year
Evaluated by overall appearance, symmetry
Incidence of a cost benefit to facial transplant
Time frame: 1 Year
This will be assessed by standard treatment of facial disfigured patients vs face transplant
1 secondary outcome
Incidence of rejection episodes on triple therapy immunosuppression
Time frame: 1 Year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Curt Cetrulo, MD, FACS, FAAP principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Face allotransplantation in people with Facial Trauma and Facial Deformity, run by Massachusetts General Hospital.
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 11 inclusion and 10 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: withdrawn, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence of motor function of face (time frame: 1 Year). The study lists 4 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 26 Nov 2024; AzTrials last refreshed its copy on 26 Oct 2026.