Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Face Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01140087
Recruitment Status : Recruiting
First Posted : June 9, 2010
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
Rolf Barth, University of Maryland, Baltimore

Tracking Information
First Submitted Date  ICMJE June 7, 2010
First Posted Date  ICMJE June 9, 2010
Last Update Posted Date November 5, 2019
Study Start Date  ICMJE September 2010
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2010)
Evaluate the success of the face transplant [ Time Frame: Monthly for 6 months, every 6 months for 2 years, then annually ]
We will measure the restoration of function, sensation, and appearance of the transplanted facial segment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2010)
Evaluate psychological effects of receiving a face transplant [ Time Frame: Monthly for 6 months, every 6 months for 2 years, then annually ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Face Transplantation
Official Title  ICMJE Maxillofacial Composite Tissue Allograft Transplantation: Face Transplant
Brief Summary

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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Transplantation: Facial Transplantation
Intervention  ICMJE Procedure: Face Transplant
Transplantation of donor facial skin, tissue, muscle, and bone as needed
Study Arms  ICMJE Experimental: Interventional
Face Transplantation
Intervention: Procedure: Face Transplant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 7, 2010)
5
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rolf Barth, MD 410-328-6020 rbarth@smail.umaryland.edu
Contact: Amanda Bartosic 410-328-0303 abartosic@smail.umaryland.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01140087
Other Study ID Numbers  ICMJE HP-00040219
N00014-07-1-0298 ( Other Grant/Funding Number: ONR )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rolf Barth, University of Maryland, Baltimore
Study Sponsor  ICMJE University of Maryland, Baltimore
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rolf Barth, MD U of Maryland
PRS Account University of Maryland, Baltimore
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP