Face Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Maryland
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Branko Bojovic, University of Maryland
ClinicalTrials.gov Identifier:
NCT01140087
First received: June 7, 2010
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

This study aims to:

  1. Perform face transplants on people who have suffered severe facial trauma with tissue and functional loss; and
  2. Evaluate the acceptance and function of the transplanted tissue.

Condition Intervention
Transplantation: Facial Transplantation
Procedure: Face Transplant

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Maxillofacial Composite Tissue Allograft Transplantation: Face Transplant

Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Evaluate the success of the face transplant [ Time Frame: Monthly for 6 months, every 6 months for 2 years, then annually ] [ Designated as safety issue: No ]
    We will measure the restoration of function, sensation, and appearance of the transplanted facial segment


Secondary Outcome Measures:
  • Evaluate psychological effects of receiving a face transplant [ Time Frame: Monthly for 6 months, every 6 months for 2 years, then annually ] [ Designated as safety issue: No ]

Estimated Enrollment: 5
Study Start Date: September 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Face Transplant
    Transplantation of donor facial skin, tissue, muscle, and bone as needed
Detailed Description:

For patients with severe facial deformities or facial wounds from traumatic injuries, we would like to pursue the use of a face transplant to help reconstruct a person's damaged face. Our goal is to not only give the patient back a normal appearance to their face but also the functioning, movement, and sensation of their face including that of the lips, mouth, and eyes. For some patients with severe face deformities simple tasks such as smiling, talking, eating, kissing a loved one, or even just being able to contain their saliva become difficult, if not impossible. These patients often become depressed because of their facial deformities.

Although there are some techniques in plastic and reconstructive surgery that can repair the look of a patient's face, often these cannot replace the moving parts of the face. Currently, patients with severe facial deformities would undergo several reconstructive surgeries with their own tissues, called autologous transplant. This surgery often leaves unacceptable scars and deformities of the patient's donor sites. Also, this conventional reconstruction method requires many returns to the operating room to carefully form and shape the transplanted free flap. Lastly, this type of reconstruction is still limited, as it does not provide a reliable return in function, sensation, and appearance for the damaged parts of the face.

Instead, if we use a composite tissue allograft (CTA), or face transplant from a donor who is brain dead such as in heart, kidney and liver transplants, we could replace the damaged parts of the face with the same missing parts that could return movement as well. However, since the transplanted facial tissues are from another person, these face transplant recipients need medicines that would keep their body from rejecting the new tissues. This new course of medicines would be their daily responsibility. Though there are risks with taking these medicines, the risks have been lowered by many prior studies that have been done with patients who have had other organ transplants. However, the risks are still a consideration when deciding to choose this option for correcting severe facial deformities.

This study aims to perform a face transplant on a person who has suffered a severe facial trauma with tissue and functional loss, and with limited other established surgical options to repair their deformities. We will conduct the surgery and prospectively follow the patient to monitor his or her clinical and functional outcomes and ensure that optimal results are achieved. We will systematically document and record the entire process of the patient's surgery and recovery. An important factor of this surgery's success is that the patient strictly follows and takes the required course of medicines to prevent rejection of the donor tissues. In order to ensure that the tissue survives and is not rejected by the patient, we will continuously check various clinical values, such as blood work, tissue samples, and x-ray images.

We would like to offer facial segment transplantation as a reconstructive option to patients with severe facial deformities. We feel facial transplantation has now become a viable option for certain patients. If successful, this will contribute to future research and development in the field of tissue transplantation. Most importantly, our goal is to offer patients the best option in reconstruction to restore both form and function who otherwise do not have another option.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-64 years of age
  • Facial defect or injury requiring facial transplantation as determined by the treating Plastic and Reconstructive Surgeon
  • Signed written informed consent
  • Able to complete psychiatric evaluations
  • Willing and able to continue immunosuppression regimen as directed by treating physician
  • Willing and able to return for follow-up visits as described in the treatment plan
  • Must have autogenous tissue options available for reconstruction in event of graft failure
  • Laboratory values as defined by research protocol
  • Willing to undergo review by Participant Selection Committee and be placed on a transplant recipient waitlist

Exclusion Criteria:

  • Pre-existing disease that would exclude the recipient from transplantation
  • Active infection
  • Ongoing substance abuse
  • HIV positive
  • Positive for Hepatitis B or C
  • Active malignancy
  • Pregnant or breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140087

Contacts
Contact: Brank Bojovic, MD 410-328-3058 facetransplant@umm.edu
Contact: Cynthia Shaffer 410-328-3058 facetransplant@umm.edu

Locations
United States, Maryland
University of Maryland, Baltimore Recruiting
Baltimore, Maryland, United States, 21201
Contact: Branko Bojovic, MD    410-328-3058    facetransplant@umm.edu   
Contact: Cynthia Shaffer    410-328-3058    facetransplant@umm.edu   
Principal Investigator: Branko Bojovic, MD         
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Branko Bojovic, MD U of Maryland
  More Information

No publications provided

Responsible Party: Branko Bojovic, Assistant Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT01140087     History of Changes
Other Study ID Numbers: HP-00040219, N00014-07-1-0298
Study First Received: June 7, 2010
Last Updated: August 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Face Transplant
Composite Tissue Allograft
Facial Allotransplantation

ClinicalTrials.gov processed this record on August 26, 2014