Facial InjuriesNCT02158793
Craniomaxillofacial Allotransplantation
A study testing Craniomaxillofacial allotransplantation in people with Facial Injuries, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to perform face transplants on people who have suffered severe facial trauma with tissue and functional loss; and evaluate the acceptance and function of the transplanted tissue. The aim of the transplant is to provide patient a more normal appearance . Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Facial Injuries
- What is being tested?
- Craniomaxillofacial allotransplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to 11 Dec 2023
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed and dated all required IRB approved consent forms
- Male or female recipient between the ages of 18-64 years. * Recipients do not need to be same gender as donor*
- Facial composite tissue defect requiring facial transplantation as determined by the treating Plastic and Reconstructive Surgeon. Inclusive facial functional subunit tissue loss. Including but not limited to irreparable peri-oral, peri-orbital, and peri-nasal damage.
- Patient has been encouraged to seek a second opinion from a Plastic Surgeon with specialized focus in facial reconstruction.
- Willingness to participate in ongoing psychiatric, psychological and social work evaluations prior to and post-transplant surgery
- The subject is able to complete pre-transplant examination and screening procedures.
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- Patient has been approved by Patient Selection Committee for placement on the recipient waiting list
- The subject is willing to continue immunosuppression regimen as directed by treating physician.
- Subject is willing and able to return to follow-up visits as described in treatment plan.
- Subjects must have autogenous tissue options available for reconstruction in event of graft failure.
- Normal GFR (glomerular filtration rate) >60
- Negative pregnancy test within 48hrs of transplant for women of childbearing age and who agree to use a reliable form of contraception for one year following transplant.
Who cannot join
- Subject has an uncontrolled infection
- Serious co-morbidities
- Positive serology for HIV; Hepatitis B/C Antigen
- Active malignancy within 5 years with the exclusion of non-melanoma
- Subject has active substance abuse/ alcoholism
- Active Severe Psychiatric Illness
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- Cognitive limitations affecting the patient's ability to provide informed consent
- Recent history of medical nonadherence
- Unstable social situation as evidence by lack of stable housing and/or lack of a supportive significant other.
- Recent history of medical non-adherence.
- Lack of stable housing and/or supportive significant other/caregiver throughout all phases of the study
- Currently active smoker within 1 year
- Subjects with any cognitive deficits related to a TBI (traumatic brain injury) and or any organic neurological disorders will not be considered for this protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Medical Center
New York, New York, 10016
About this study
The purpose of this study is to perform face transplants on people who have suffered severe facial trauma with tissue and functional loss; and evaluate the acceptance and function of the transplanted tissue. The aim of the transplant is to provide patient a more normal appearance . Additionally we aim to restore functioning, movement, and sensation of their face including that of the lips, mouth, and eyes.
Read the detailed description
This study is to perform facial transplants in patients with severe facial deformities or facial wounds from traumatic injuries. The transplant is to help reconstruct a person's damaged face. The aim of the transplant is to provide patient a more normal appearance . Additionally we aim to restore functioning, movement, and sensation of their face including that of the lips, mouth, and eyes.
There are some procedures in plastic and reconstructive surgery that can repair the look of a patient's face, but often can't replace the movement and use of the face. Currently, patients with severe facial deformities would undergo several reconstructive surgeries with their own tissues, called autologous transplant. Conventional reconstruction method requires multiple surgeries in order to form and shape the transplanted tissue. Because this type of reconstruction is limited, it does not provide a reliable return in function, sensation, and appearance for the damaged parts of the face.
This study uses a composite tissue allograft , or face transplant from a donor who is brain dead such as in heart, kidney and liver transplants. The damaged parts of the face could return movement as well. Transplanted patients are required to take lifelong immunosuppression drugs which have risks, which are still a consideration when deciding to choose this option for correcting severe facial deformities.
We will conduct the surgery and prospectively follow the patient to monitor signs of rejection of the transplanted face. Additionally, patients will be constantly evaluated for clinical and functional outcomes and ensure that optimal results are achieved.
- Conditions
- Facial Injuries
- Being tested
- Craniomaxillofacial allotransplantation
- Keywords
- face transplant, Craniomaxillofacial Allotransplantation, facial disfigurement, facial trauma
- Medical subject headings
- Facial Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Craniomaxillofacial allotransplantationProcedure or surgery
Transplantation of donor face
| Study group | Role | What they receive |
|---|---|---|
| Face Transplant recipient | Experimental | Single Arm study, all participants will receive Craniomaxillofacial allotransplantation Receives: Procedure: Craniomaxillofacial allotransplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the success of the face transplant
We will measure the restoration of function, sensation, and appearance of the transplanted facial segment.
These will be measured using various multi-disciplinary evaluations including swallow studies, photography, speech therapy evaluation, Occupational therapy evaluation, electromyogram (EMG) , Nerve Conduction Study (NCS), CT Angiogram, Functional ( Magnetic Resononance Image) MRI, vision exams, pathology samples to check for rejection, Blood tests
Measured: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
Secondary outcomes (1)
Evaluate psychological effects of receiving a face transplant
Psychological outcome will be measured using patient reported outcome tools such as MoCA; BIDQ; SF-36; PHQ-9
Measured: Monthly for 6 months, every 6 months for 2 years, then annually until year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study startJun 2014
- Primary completion11 Dec 2023
- Study completion11 Dec 2023
Why it stopped: It was determined that the study would be integrated into the standard clinical care.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial InjuriesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduardo Rodriguez, MD, DDS, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158793
- Sponsor's protocol ID
- 14-00550
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2014
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Craniomaxillofacial Allotransplantation
- ClinicalTrials.gov ID
- NCT02158793
- Acronym / sponsor ID
- 14-00550
- Conditions
- Facial Injuries
- Keywords
- face transplant, Craniomaxillofacial Allotransplantation, facial disfigurement, facial trauma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was determined that the study would be integrated into the standard clinical care.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 9 Jun 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.
The purpose of this study is to perform face transplants on people who have suffered severe facial trauma with tissue and functional loss; and evaluate the acceptance and function of the transplanted tissue. The aim of the transplant is to provide patient a more normal appearance . Additionally we aim to restore functioning, movement, and sensation of their face including that of the lips, mouth, and eyes.
Detailed description
This study is to perform facial transplants in patients with severe facial deformities or facial wounds from traumatic injuries. The transplant is to help reconstruct a person's damaged face. The aim of the transplant is to provide patient a more normal appearance . Additionally we aim to restore functioning, movement, and sensation of their face including that of the lips, mouth, and eyes.
There are some procedures in plastic and reconstructive surgery that can repair the look of a patient's face, but often can't replace the movement and use of the face. Currently, patients with severe facial deformities would undergo several reconstructive surgeries with their own tissues, called autologous transplant. Conventional reconstruction method requires multiple surgeries in order to form and shape the transplanted tissue. Because this type of reconstruction is limited, it does not provide a reliable return in function, sensation, and appearance for the damaged parts of the face.
This study uses a composite tissue allograft , or face transplant from a donor who is brain dead such as in heart, kidney and liver transplants. The damaged parts of the face could return movement as well. Transplanted patients are required to take lifelong immunosuppression drugs which have risks, which are still a consideration when deciding to choose this option for correcting severe facial deformities.
We will conduct the surgery and prospectively follow the patient to monitor signs of rejection of the transplanted face. Additionally, patients will be constantly evaluated for clinical and functional outcomes and ensure that optimal results are achieved.
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: Craniomaxillofacial allotransplantationSingle Arm study, all participants will receive Craniomaxillofacial allotransplantation |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Signed and dated all required IRB approved consent forms
- Male or female recipient between the ages of 18-64 years. * Recipients do not need to be same gender as donor*
- Facial composite tissue defect requiring facial transplantation as determined by the treating Plastic and Reconstructive Surgeon. Inclusive facial functional subunit tissue loss. Including but not limited to irreparable peri-oral, peri-orbital, and peri-nasal damage.
- Patient has been encouraged to seek a second opinion from a Plastic Surgeon with specialized focus in facial reconstruction.
- Willingness to participate in ongoing psychiatric, psychological and social work evaluations prior to and post-transplant surgery
Key exclusion criteria (13 listed)
- Subject has an uncontrolled infection
- Serious co-morbidities
- Positive serology for HIV; Hepatitis B/C Antigen
- Active malignancy within 5 years with the exclusion of non-melanoma
- Subject has active substance abuse/ alcoholism
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 |
|---|---|---|
| Craniomaxillofacial allotransplantationTransplantation of donor face | Procedure or surgery | Face Transplant recipient |
Primary outcome
Evaluate the success of the face transplant
Time frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
We will measure the restoration of function, sensation, and appearance of the transplanted facial segment. These will be measured using various multi-disciplinary evaluations including swallow studies, photography, speech therapy evaluation, Occupational therapy evaluation, electromyogram (EMG) , Nerve Conduction Study (NCS), CT Angiogram, Functional ( Magnetic Resononance Image) MRI, vision exams, pathology samples to check for rejection, Blood tests
1 secondary outcome
Evaluate psychological effects of receiving a face transplant
Time frame: Monthly for 6 months, every 6 months for 2 years, then annually until year 5
Results and safety
The study was stopped early (reason given: It was determined that the study would be integrated into the standard clinical care.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
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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.
Eduardo Rodriguez, MD, DDS principal investigator
NYU Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Craniomaxillofacial allotransplantation in people with Facial Injuries, run by NYU Langone Health at 1 site in United States.
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 12 inclusion and 13 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: stopped early, as of the sponsor's last update on 27 Jun 2024. 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 United States. 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 was stopped early (reason given: It was determined that the study would be integrated into the standard clinical care.). Results are not available in the source record.
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?
Evaluate the success of the face transplant (time frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5). 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 27 Jun 2024.