Transplantation: Facial TransplantationNCT05117190
Human Composite Facial Allotransplantation
A study testing Facial Allotransplantation in people with Transplantation: Facial Transplantation, run by Methodist Health System at 1 site in United States.
Trial summary
Allotransplantation of maxillofacial of subject with severe facial deformities due to traumatic events. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Transplantation: Facial Transplantation
- What is being tested?
- Facial Allotransplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2014to 18 Mar 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between ages 18-70 years
- Must be willing to undergo major facial reconstruction
- Be able to understand the pre and post-transplantation evaluation, physical therapy, and follow up procedures
- Conventional reconstruction deemed unsatisfactory
Who cannot join
- Medically unable to provide consent
- Active infections such as Human Immunodeficiency Virus, mycobacteria, hepatitis B, and hepatitis C
- Recent history of alcohol or IV drug or chemical dependency
- Psychiatric evaluation that indicate mental instability or non-compliance
- Cognitively impaired and Terminally ill
- Women of child bearing age with intent to conceive, pregnant or lactating
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- Unable to receive immunosuppression after transplantation because of either geographic or financial limitations
- End stage organ disease (renal failure, Congestive Heart Failure (CHF), Chronic Obstructive Pulmonary Disease (COPD), etc.)
- Chronic infections such as osteomyelitis
Trial locations and contacts
1 site in 1 country.
About this study
Allotransplantation of maxillofacial of subject with severe facial deformities due to traumatic events.
Read the detailed description
A facial transplantation is a highly dynamic, prolonged operation requiring teams communicating seamlessly through its duration. This is similar to complex solid organ transplant teams at Methodist Transplant Institute. The Institute's clinical experience in management of complex facial defects and deformities along with the personnel and infrastructure at Methodist Dallas transplant institute would help develop a center for Facial Allotransplantation. The team experience, true collaboration, creativity and a unique approach to each patient would help provide the optimal care and reconstruction for the face allotransplant patient both before and after surgery.
The purpose of this study is centered on the advancement of a safe and effective procedure for Facial Allotransplantation at Methodist Hospital Medical Center at Dallas. Composite tissue allotransplantation for facial reconstruction is in its infancy as liver transplantation was 30 years ago when the first liver transplant was completed in Texas. This study will establish Methodist Hospital System as a center for Facial Allotransplantation for reconstruction of extensive facial defects resulting in functional loss and poor quality of life.
Patient participation post transplantation will either be for life, or failure of the composite tissue allograft. Patient enrollment will be initiated immediately after the IRB approval. The enrollment period will be completed after the patient receives the final transplant, and the study will be completed at 24 months after the final transplant. However, all patients enrolled into the study will have lifelong follow up with immunosuppressive management, psychological support, and evaluation of functional recovery per protocol.
- Conditions
- Transplantation: Facial Transplantation
- Being tested
- Facial Allotransplantation
- Keywords
- Facial Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial AllotransplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Facial Deformity | Other | Face not the normal shape because of injury or illness. Receives: Procedure: Facial Allotransplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Facial Clinimetric Evaluation Scale
validated quality-of-life instrument that is used to assess facial impairment and disability after facial paralysis.
Measured: measured at 6 weeks
Modified Facial Clinimetric Evaluation Scale
validated quality-of-life instrument that is used to assess facial impairment and disability after facial paralysis.
Measured: measured at 3 months
Modified Facial Clinimetric Evaluation Scale
validated quality-of-life instrument that is used to assess facial impairment and disability after facial paralysis.
Measured: measured at 6 months
Modified Facial Clinimetric Evaluation Scale
validated quality-of-life instrument that is used to assess facial impairment and disability after facial paralysis.
Measured: measured at 12 months
Modified Facial Clinimetric Evaluation Scale
validated quality-of-life instrument that is used to assess facial impairment and disability after facial paralysis.
Measured: measured at 18 months
Modified Facial Clinimetric Evaluation Scale
validated quality-of-life instrument that is used to assess facial impairment and disability after facial paralysis.
Measured: measured at 24 months
Facial Disability Index
a disease-specific, self-report instrument for the assessment of disabilities of patients with facial nerve disorders
Measured: measured at 6 weeks
Facial Disability Index
a disease-specific, self-report instrument for the assessment of disabilities of patients with facial nerve disorders
Measured: measured at 3 months
Facial Disability Index
a disease-specific, self-report instrument for the assessment of disabilities of patients with facial nerve disorders
Measured: measured at 6 months
Facial Disability Index
a disease-specific, self-report instrument for the assessment of disabilities of patients with facial nerve disorders
Measured: measured at 12 months
Facial Disability Index
a disease-specific, self-report instrument for the assessment of disabilities of patients with facial nerve disorders
Measured: measured at 18 months
Facial Disability Index
a disease-specific, self-report instrument for the assessment of disabilities of patients with facial nerve disorders
Measured: measured at 24 months
SF-36 Health Survey
a set of generic, coherent, and easily administered quality-of-life measures
Measured: measured at 6 weeks
SF-36 Health Survey
a set of generic, coherent, and easily administered quality-of-life measures
Measured: measured at 3 months
SF-36 Health Survey
a set of generic, coherent, and easily administered quality-of-life measures
Measured: measured at 6 months
SF-36 Health Survey
a set of generic, coherent, and easily administered quality-of-life measures
Measured: measured at 12 months
SF-36 Health Survey
a set of generic, coherent, and easily administered quality-of-life measures
Measured: measured at 18 months
SF-36 Health Survey
a set of generic, coherent, and easily administered quality-of-life measures
Measured: measured at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start21 Oct 2014
- Primary completion18 Mar 2021
- Study completion18 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplantation: Facial TransplantationStudies of the same condition, open and under way.
- 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Likith V. Reddy, MD, Principal investigator, Methodist Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117190
- Sponsor's protocol ID
- 028.TRN.2014.D
- Status last verified
- Feb 2022
- First submitted
- 15 Apr 2015
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Composite Facial Allotransplantation
- ClinicalTrials.gov ID
- NCT05117190
- Acronym / sponsor ID
- 028.TRN.2014.D
- Conditions
- Transplantation: Facial Transplantation
- Keywords
- Facial Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 21 Oct 2014 (actual)
- Primary completion
- 18 Mar 2021 (actual)
- Study completion
- 18 Mar 2021 (actual)
- First posted
- 11 Nov 2021 (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.
Allotransplantation of maxillofacial of subject with severe facial deformities due to traumatic events.
Detailed description
A facial transplantation is a highly dynamic, prolonged operation requiring teams communicating seamlessly through its duration. This is similar to complex solid organ transplant teams at Methodist Transplant Institute. The Institute's clinical experience in management of complex facial defects and deformities along with the personnel and infrastructure at Methodist Dallas transplant institute would help develop a center for Facial Allotransplantation. The team experience, true collaboration, creativity and a unique approach to each patient would help provide the optimal care and reconstruction for the face allotransplant patient both before and after surgery.
The purpose of this study is centered on the advancement of a safe and effective procedure for Facial Allotransplantation at Methodist Hospital Medical Center at Dallas. Composite tissue allotransplantation for facial reconstruction is in its infancy as liver transplantation was 30 years ago when the first liver transplant was completed in Texas. This study will establish Methodist Hospital System as a center for Facial Allotransplantation for reconstruction of extensive facial defects resulting in functional loss and poor quality of life.
Patient participation post transplantation will either be for life, or failure of the composite tissue allograft. Patient enrollment will be initiated immediately after the IRB approval. The enrollment period will be completed after the patient receives the final transplant, and the study will be completed at 24 months after the final transplant. However, all patients enrolled into the study will have lifelong follow up with immunosuppressive management, psychological support, and evaluation of functional recovery per protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Facial Deformity | Other | Procedure: Facial AllotransplantationFace not the normal shape because of injury or illness. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between ages 18-70 years
- Must be willing to undergo major facial reconstruction
- Be able to understand the pre and post-transplantation evaluation, physical therapy, and follow up procedures
- Conventional reconstruction deemed unsatisfactory
Key exclusion criteria (9 listed)
- Medically unable to provide consent
- Active infections such as Human Immunodeficiency Virus, mycobacteria, hepatitis B, and hepatitis C
- Recent history of alcohol or IV drug or chemical dependency
- Psychiatric evaluation that indicate mental instability or non-compliance
- Cognitively impaired and Terminally ill
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 |
|---|---|---|
| Facial Allotransplantation | Procedure or surgery | Facial Deformity |
Primary outcome
Modified Facial Clinimetric Evaluation Scale
Time frame: measured at 6 weeks
validated quality-of-life instrument that is used to assess facial impairment and disability after facial paralysis.
Modified Facial Clinimetric Evaluation Scale
Time frame: measured at 3 months
validated quality-of-life instrument that is used to assess facial impairment and disability after facial paralysis.
Modified Facial Clinimetric Evaluation Scale
Time frame: measured at 6 months
validated quality-of-life instrument that is used to assess facial impairment and disability after facial paralysis.
Modified Facial Clinimetric Evaluation Scale
Time frame: measured at 12 months
validated quality-of-life instrument that is used to assess facial impairment and disability after facial paralysis.
Modified Facial Clinimetric Evaluation Scale
Time frame: measured at 18 months
validated quality-of-life instrument that is used to assess facial impairment and disability after facial paralysis.
Modified Facial Clinimetric Evaluation Scale
Time frame: measured at 24 months
validated quality-of-life instrument that is used to assess facial impairment and disability after facial paralysis.
Facial Disability Index
Time frame: measured at 6 weeks
a disease-specific, self-report instrument for the assessment of disabilities of patients with facial nerve disorders
Facial Disability Index
Time frame: measured at 3 months
a disease-specific, self-report instrument for the assessment of disabilities of patients with facial nerve disorders
Facial Disability Index
Time frame: measured at 6 months
a disease-specific, self-report instrument for the assessment of disabilities of patients with facial nerve disorders
Facial Disability Index
Time frame: measured at 12 months
a disease-specific, self-report instrument for the assessment of disabilities of patients with facial nerve disorders
Facial Disability Index
Time frame: measured at 18 months
a disease-specific, self-report instrument for the assessment of disabilities of patients with facial nerve disorders
Facial Disability Index
Time frame: measured at 24 months
a disease-specific, self-report instrument for the assessment of disabilities of patients with facial nerve disorders
SF-36 Health Survey
Time frame: measured at 6 weeks
a set of generic, coherent, and easily administered quality-of-life measures
SF-36 Health Survey
Time frame: measured at 3 months
a set of generic, coherent, and easily administered quality-of-life measures
SF-36 Health Survey
Time frame: measured at 6 months
a set of generic, coherent, and easily administered quality-of-life measures
SF-36 Health Survey
Time frame: measured at 12 months
a set of generic, coherent, and easily administered quality-of-life measures
SF-36 Health Survey
Time frame: measured at 18 months
a set of generic, coherent, and easily administered quality-of-life measures
SF-36 Health Survey
Time frame: measured at 24 months
a set of generic, coherent, and easily administered quality-of-life measures
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 23 Mar 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. This study is not recruiting at the moment.
Likith V. Reddy, MD principal investigator
Methodist Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facial Allotransplantation in people with Transplantation: Facial Transplantation, run by Methodist Health System 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 4 inclusion and 9 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 23 Mar 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 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 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?
Modified Facial Clinimetric Evaluation Scale (time frame: measured at 6 weeks). The study lists 18 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 23 Mar 2026.