Face Transplantation
Condition: Transplantation: Facial Transplantation
Study type: Interventional

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.
    

Intervention name(s): Face Transplant
Intervention type(s): Procedure
Intervention description(s): Transplantation of donor facial skin, tissue, muscle, and bone as needed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Face Transplant; Composite Tissue Allograft; Facial Allotransplantation