Face Transplantation for Treatment of Severe Facial Deformity

January 25, 2021 updated by: Bodhan Pomahac, Brigham and Women's Hospital

Transplantation of Allograft Face or Facial Subunit for Treatment of Severe Facial Deformation

Face transplantation surgery is the transfer of face tissue from a deceased human donor to a patient with a severe facial deformity. Face transplantation is an innovative reconstructive procedure that has the potential to significantly improve the lives of patients with severe facial injuries. The purpose of this study is to develop the best practices for facial transplantation that will improve the outcomes of future face transplant recipients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The United States Department of Defense (DoD) awarded Brigham and Women's Hospital (BWH) a research contract to fund 5 face transplantation surgeries.

The investigators are now actively seeking candidates for the procedure. The primary requirements to be considered as a candidate for face transplant surgery are: at least 18 years old; lost a major part of the face, such as the nose or the lips, or lost at least 25% of their facial tissue; and the facial injury cannot be treated acceptably by conventional reconstructive surgery. There are number of other factors that the investigators consider to determine who would be a suitable candidate.

From the time the investigators begin our search for a qualified face transplant recipient to the continuing care the investigators provide following surgery, a significant amount of time, expertise, and attentiveness is contributed toward making the procedure a progressive success. Below is an overview of what happens before, during and after a face transplant procedure.

Face transplant candidates go through an extensive screening process that is likely to last several months. This screening includes a psychiatric and social support evaluation and a series of imaging tests to help determine a patient's physical and mental readiness for the procedure. If, upon completion of the screening process, it is determined that a patient is a suitable candidate, the investigators will place the patient on a transplant waiting list. The investigators will then begin working to find a donor who matches the recipient's tissue requirements - e.g., similar age, right blood type. This search could take many months, and, if a suitable donor is not found within one year, the investigators will speak with the patient to determine whether they're willing to continue waiting. When a donor is found, the investigators will immediately inform the patient about when to arrive at the hospital for the operation. As the timing for this type of procedure is extremely important, patients are expected to be readily available.

The area most likely to be reconstructed in a face transplant is the central region of the face, which includes the nose and lips, as these facial structures are the most difficult to reconstruct with conventional plastic surgery techniques. In our most recent case, the face transplant included 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. Surgeons will then connect the facial graft blood vessels to the patient's blood vessels under a microscope to restore blood circulation before connecting nerves and other tissue, such as bone, cartilage and muscles, as needed.

While the face transplant is taking place, a separate, smaller surgery will also be performed. The investigators will take a skin sample (graft) from the arm of the donor and then attach the sample to the patient's chest or abdomen. The intent is to have the graft behave like the face transplant tissue, eventually becoming part of the patient's own skin. This is done so that later the investigators can take tiny samples (biopsies) of the new chest/abdomen tissue to look for signs of rejection, thereby minimizing the need to disturb the new face tissue after surgery.

Immediately after surgery, the face transplant recipient will be taken to the Intensive Care Unit (ICU) for observation. The patient will typically stay in the ICU for one or two days and then be moved to a private room. At this point, a physical therapist will help the patient regain as much facial movement as possible, and a psychiatrist will discuss any psychological concerns.

The patient will stay in the hospital until both the plastic surgery and medical transplant teams agree that it is safe for the patient to return home. This post-operative stay is anticipated to be approximately 7-14 days, but can vary due to a number of factors.

Following their discharge, face transplant patients will need to return to BWH for routine visits. These visits will include monitoring transplant drug levels (immune suppressants) through regular blood tests, imaging tests, assessing quality of life and checking for the return of sensation and movement to the face. The investigators will also periodically examine small tissue samples from the chest/abdomen graft under a microscope to look for any signs of rejection. These visits will typically take place on a weekly basis for the first three months and then at least once a month for the first year following surgery.

After the first year, it is expected that face transplant patients will need to visit the hospital less and less as time passes. However, patients should be prepared to make a lifetime commitment to immune suppressants to help prevent the rejection of the transplanted face tissue.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • 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
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hospital

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

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18 and 60 years.
  • Loss of a major part of the face, such as the nose or the lips, or at least 25% of the facial tissue.
  • The facial defect cannot be restored with traditional reconstruction techniques.
  • Signed written informed consent.
  • Willing to complete psychological and social evaluations.
  • Willing to take immunosuppressants - drugs that help prevent rejection of the transplant - for life.
  • Willing to return for follow-up visits as determined by the treating physician and to comply with extensive post-transplant rehabilitation therapy.
  • Willing to receive standard vaccinations prior to the transplant, such as influenza and hepatitis B.

Exclusion Criteria:

  • Active malignancy.
  • High risk of return of malignancy.
  • History of persistent non-compliance.
  • Findings of psychological evaluation that indicate inability to comply with physician's orders or mental instability.
  • Any diagnosis that puts the subject at risk during the face transplant surgery.
  • Absence of adequate donor sites for skin grafting in the event of 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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Face transplantation
Procedure: Facial Allograft Transplantation
Facial allograft transplantation surgery is the transfer of face tissue from a deceased human donor to a patient with a severe facial deformity.
Other Names:
  • face transplantation
  • facial transplantation
  • composite facial allograft transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcomes of face transplantation.
Time Frame: Subjects will be followed for 18 months after face transplantation
We will undertake an objective evaluation of the results of face transplantation in an 'outcome-oriented study'.
Subjects will be followed for 18 months after face transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy and optimization of the immune suppression protocol.
Time Frame: 18 months
We will evaluate the risks of rejection or likelihood of tolerance induction by measuring specific parameters in the blood or tissue, including: Serum alloantibodies concentration, numbers/phenotype of specific T cell alloreactivity in the peripheral blood, phenotypic characterization of graft infiltrating cells and local gene expression of cells and cytokines.
18 months
Procedural outcomes of face transplantation
Time Frame: From subject recruitment to 18 months after transplantation
We will optimize the screening, pre-operative, peri-operative and follow-up procedures of face transplantation.
From subject recruitment to 18 months after transplantation
Functional outcomes of face transplantation
Time Frame: Subjects will be followed for 18 months following face transplantation
We will evaluate the return of facial sensory and motor function after face transplantation.
Subjects will be followed for 18 months following face transplantation
Psychosocial outcomes of face transplantation
Time Frame: Subjects will be followed up for 18 months following face transplantation
We will evaluate the psychological and social outcomes of face transplantation by evaluating the subject's quality of life at various time points before and after transplantation.
Subjects will be followed up for 18 months following face transplantation
Financial and economic aspects of face transplantation
Time Frame: Subjects will be followed for 18 months after face transplantation
We will evaluate the cost-effectiveness of face transplantation.
Subjects will be followed for 18 months after face transplantation

Collaborators and Investigators

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

Sponsor

Brigham and Women's Hospital

Collaborators

United States Department of Defense

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (ACTUAL)

September 1, 2009

Primary Completion (ACTUAL)

October 31, 2019

Study Completion (ACTUAL)

November 12, 2019

Study Registration Dates

First Submitted

January 20, 2011

First Submitted That Met QC Criteria

January 20, 2011

First Posted (ESTIMATE)

January 21, 2011

Study Record Updates

Last Update Posted (ACTUAL)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008P000550
  • W911QY09C0216 (OTHER_GRANT: Department of Defense)

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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