Face Transplantation Clinical Trial

August 30, 2023 updated by: Frank Papay, MD, The Cleveland Clinic

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Face Transplantation
Surgical Procedure Composite Facial Transplant
Procedure: Surgical Procedure Composite Facial Transplant
Single Center Prospective Clinical Study to Document the Safety and Feasibility of the Surgical Procedure for Composite Facial Allograft Transplantation
Other Names:
  • Face Transplant

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Patients will be carefully screened and monitored post-operatively for signs of rejection or flap failure for 5 years.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
Patients will be carefully screened and monitored post-operatively for signs of rejection or flap failure for 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Cleveland Clinic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United States Department of Defense

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Frank Papay, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2011

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 4, 2011

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB6914

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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