Severe Facial DeformitiesNCT01269164
Face Transplantation Clinical Trial
A study testing Surgical Procedure Composite Facial Transplant in people with Severe Facial Deformities, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to apply human facial allograft transplant to the subjects with severe facial deformities or disfigurements in order to provide adequate coverage, aesthetic appearance and functional outcome. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Severe Facial Deformities
- What is being tested?
- Surgical Procedure Composite Facial Transplant
- 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
- Jul 2010to Nov 2020
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject must be willing to sign the informed consent and agree to all follow up procedures, including the realistic understanding of the impact of face allotransplantation on their lifestyle
- Subjects will be evaluated by plastic surgeon to assess indications for facial allotransplantations based on severity and complexity of facial deformity
- Subjects ages 18-60.
- Subject must be willing to undergo a psychiatric and social services pre-transplantation evaluation
- Subject must be willing to undergo major face surgery
- Subject must be a candidate for general anesthesia
Show all 10Show fewer
- Subjects must be willing to comply with post transplant physical therapy.
- Subject must be willing and able to receive potent drugs to induce and maintain immunosuppression and follow the infection prophylaxis protocol
- Subject must be willing to receive standard vaccinations such as influenza, pneumococcus, and hepatitis B.
- Subjects must be free of malignant tumors for 5 or more years with the exception of certain skin cancer.
Who cannot join
- Subject that shows history of persistent non-compliance
- Findings of the psychiatric evaluation that may indicate non-compliance or mental instability
- Presence of an active infection including Human Immunodeficiency Virus, mycobacteria, hepatitis B, and hepatitis C
- Presence of an occult infection for example, dental abscess, UTI, tuberculosis, or history of systemic/occult infection within 3 months of surgery
- Any current Chemical Dependency including alcohol
- Subjects at high risk for the recurrence of malignancy with the exception of certain skin cancers
- Any diagnosis that the qualifying plastic surgeon feels would put the subject at high risk for the surgical procedure of face transplantation
- Subjects who do not have adequate donor site tissue available for coverage in the event of face transplant failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protocol for Composite Facial Allograft Transplant
The purpose of this study is to apply human facial allograft transplant to the subjects with severe facial deformities or disfigurements in order to provide adequate coverage, aesthetic appearance and functional outcome.
Read the detailed description
The human scalp and face define two important body units, both functionally and aesthetically. Traumatic deformities of the head and neck region resulting from burn injuries, gun shot wounds, or ablative tumor surgeries may involve the defect of the skin, subcutaneous tissue, muscle or the combination of all these elements. In most cases, the ideal reconstruction is very difficult to achieve. Sometimes, a major part of face along with the ear or the nose may be involved. The extensive scalp loss due to burn or avulsion injury is another deforming and psychologically debilitating condition presenting as a major reconstructive challenge. An ideal reconstructive procedure should replace the missing tissues and restore the motor and sensory function. Traditional reconstructive procedures of facial deformities involve skin grafting, local flap applications, tissue expansion, and prefabrication as well as free tissue transfers. The primary goal during facial reconstruction is restoration of the function and aesthetic appearance. To obtain satisfactory results, missing parts should be replaced only by tissues of the same color and texture. The purpose of this study is to apply human facial allograft transplant to the subjects with severe facial deformities or disfigurements in order to provide adequate coverage, aesthetic appearance and functional outcome.
- Conditions
- Severe Facial Deformities
- Being tested
- Surgical Procedure Composite Facial Transplant
- Keywords
- Face Transplant, Facial Transplantation, Composite Facial Allograft Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Procedure Composite Facial TransplantProcedure or surgery
Also called Face Transplant
Single Center Prospective Clinical Study to Document the Safety and Feasibility of the Surgical Procedure for Composite Facial Allograft Transplantation
| Study group | Role | What they receive |
|---|---|---|
| Face Transplantation | Experimental | Surgical Procedure Composite Facial Transplant Receives: Procedure: Surgical Procedure Composite Facial Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the success of the face transplant
Demonstrate stable engraftment and restoration of facial skin/bone coverage and sensory-motor function in recipients of composite tissue allografts of vascularized skin, bone, and soft tissue augments(nose, ear, lips, eyelids, etc)under standard immunopression protocol.
Measured: Patients will be carefully screened and monitored post-operatively for signs of rejection or flap failure for 5 years.
Secondary outcomes (1)
Evaluate tolerogenic properties of the immunosuppression protocol
Characterize tolerogenic properties of our immunosuppression protocol, by monitoring of donor specific chimerism and presence of T regulatory cells in the face allograft transplant recipients.
Measured: Patients will be carefully screened and monitored post-operatively for signs of rejection or flap failure for 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startJul 2010
- Primary completionAug 2020
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Facial DeformitiesStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Frank Papay, MD, The Cleveland Clinic
- Investigators
- Frank Papay, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269164
- Sponsor's protocol ID
- IRB6914
- Status last verified
- Aug 2023
- First submitted
- 30 Dec 2010
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for Composite Facial Allograft Transplant
- ClinicalTrials.gov ID
- NCT01269164
- Acronym / sponsor ID
- IRB6914
- Conditions
- Severe Facial Deformities
- Keywords
- Face Transplant, Facial Transplantation, Composite Facial Allograft Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Jul 2010
- Primary completion
- Aug 2020 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 4 Jan 2011 (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 apply human facial allograft transplant to the subjects with severe facial deformities or disfigurements in order to provide adequate coverage, aesthetic appearance and functional outcome.
Detailed description
The human scalp and face define two important body units, both functionally and aesthetically. Traumatic deformities of the head and neck region resulting from burn injuries, gun shot wounds, or ablative tumor surgeries may involve the defect of the skin, subcutaneous tissue, muscle or the combination of all these elements. In most cases, the ideal reconstruction is very difficult to achieve. Sometimes, a major part of face along with the ear or the nose may be involved. The extensive scalp loss due to burn or avulsion injury is another deforming and psychologically debilitating condition presenting as a major reconstructive challenge. An ideal reconstructive procedure should replace the missing tissues and restore the motor and sensory function. Traditional reconstructive procedures of facial deformities involve skin grafting, local flap applications, tissue expansion, and prefabrication as well as free tissue transfers. The primary goal during facial reconstruction is restoration of the function and aesthetic appearance. To obtain satisfactory results, missing parts should be replaced only by tissues of the same color and texture. The purpose of this study is to apply human facial allograft transplant to the subjects with severe facial deformities or disfigurements in order to provide adequate coverage, aesthetic appearance and functional outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Face Transplantation | Experimental | Procedure: Surgical Procedure Composite Facial TransplantSurgical Procedure Composite Facial Transplant |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Subject must be willing to sign the informed consent and agree to all follow up procedures, including the realistic understanding of the impact of face allotransplantation on their lifestyle
- Subjects will be evaluated by plastic surgeon to assess indications for facial allotransplantations based on severity and complexity of facial deformity
- Subjects ages 18-60.
- Subject must be willing to undergo a psychiatric and social services pre-transplantation evaluation
- Subject must be willing to undergo major face surgery
Key exclusion criteria (8 listed)
- Subject that shows history of persistent non-compliance
- Findings of the psychiatric evaluation that may indicate non-compliance or mental instability
- Presence of an active infection including Human Immunodeficiency Virus, mycobacteria, hepatitis B, and hepatitis C
- Presence of an occult infection for example, dental abscess, UTI, tuberculosis, or history of systemic/occult infection within 3 months of surgery
- Any current Chemical Dependency including alcohol
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 |
|---|---|---|
| Surgical Procedure Composite Facial TransplantAlso: Face TransplantSingle Center Prospective Clinical Study to Document the Safety and Feasibility of the Surgical Procedure for Composite Facial Allograft Transplantation | Procedure or surgery | Face Transplantation |
Primary outcome
Evaluate the success of the face transplant
Time frame: Patients will be carefully screened and monitored post-operatively for signs of rejection or flap failure for 5 years.
Demonstrate stable engraftment and restoration of facial skin/bone coverage and sensory-motor function in recipients of composite tissue allografts of vascularized skin, bone, and soft tissue augments(nose, ear, lips, eyelids, etc)under standard immunopression protocol.
1 secondary outcome
Evaluate tolerogenic properties of the immunosuppression protocol
Time frame: Patients will be carefully screened and monitored post-operatively for signs of rejection or flap failure for 5 years.
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 31 Aug 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Severe Facial Deformities
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingPhase 3
A Study of Lebrikizumab in Adults and Adolescents With Face and Neck Atopic Dermatitis
Atopic Dermatitis
Recruiting
Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles
Wrinkle
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.
Frank Papay, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Procedure Composite Facial Transplant in people with Severe Facial Deformities, run by The Cleveland Clinic 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 10 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: finished, as of the sponsor's last update on 31 Aug 2023. 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?
Evaluate the success of the face transplant (time frame: Patients will be carefully screened and monitored post-operatively for signs of rejection or flap failure for 5 years.). 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 31 Aug 2023.