Craniomaxillofacial Allotransplantation

This study is to perform facial transplants in patients with severe facial deformities or
facial wounds from traumatic injuries. The transplant is to help reconstruct a person's
damaged face. The aim of the transplant is to provide patient a more normal appearance .
Additionally we aim to restore functioning, movement, and sensation of their face including
that of the lips, mouth, and eyes.

There are some procedures in plastic and reconstructive surgery that can repair the look of a
patient's face, but often can't replace the movement and use of the face. Currently, patients
with severe facial deformities would undergo several reconstructive surgeries with their own
tissues, called autologous transplant. Conventional reconstruction method requires multiple
surgeries in order to form and shape the transplanted tissue. Because this type of
reconstruction is limited, it does not provide a reliable return in function, sensation, and
appearance for the damaged parts of the face.

This study uses a composite tissue allograft , or face transplant from a donor who is brain
dead such as in heart, kidney and liver transplants. The damaged parts of the face could
return movement as well. Transplanted patients are required to take lifelong
immunosuppression drugs which have risks, which are still a consideration when deciding to
choose this option for correcting severe facial deformities.

We will conduct the surgery and prospectively follow the patient to monitor signs of
rejection of the transplanted face. Additionally, patients will be constantly evaluated for
clinical and functional outcomes and ensure that optimal results are achieved.

Inclusion criteria:

- Signed and dated all required IRB approved consent forms

- Male or female recipient between the ages of 18-64 years. * Recipients do not need to
be same gender as donor*

- Facial composite tissue defect requiring facial transplantation as determined by the
treating Plastic and Reconstructive Surgeon. Inclusive facial functional subunit
tissue loss. Including but not limited to irreparable peri-oral, peri-orbital, and
peri-nasal damage.

- Patient has been encouraged to seek a second opinion from a Plastic Surgeon with
specialized focus in facial reconstruction.

- Willingness to participate in ongoing psychiatric, psychological and social work
evaluations prior to and post-transplant surgery

- The subject is able to complete pre-transplant examination and screening procedures.

- Patient has been approved by Patient Selection Committee for placement on the
recipient waiting list

- The subject is willing to continue immunosuppression regimen as directed by treating
physician.

- Subject is willing and able to return to follow-up visits as described in treatment
plan.

- Subjects must have autogenous tissue options available for reconstruction in event of
graft failure.

- Normal GFR (glomerular filtration rate) >60

- Negative pregnancy test within 48hrs of transplant for women of childbearing age and
who agree to use a reliable form of contraception for one year following transplant.

Exclusion criteria:

- Subject has an uncontrolled infection

- Serious co-morbidities

- Positive serology for HIV; Hepatitis B/C Antigen

- Active malignancy within 5 years with the exclusion of non-melanoma

- Subject has active substance abuse/ alcoholism

- Active Severe Psychiatric Illness

- Cognitive limitations affecting the patient's ability to provide informed consent

- Recent history of medical nonadherence

- Unstable social situation as evidence by lack of stable housing and/or lack of a
supportive significant other.

- Recent history of medical non-adherence.

- Lack of stable housing and/or supportive significant other/caregiver throughout all
phases of the study

- Currently active smoker within 1 year

- Subjects with any cognitive deficits related to a TBI (traumatic brain injury) and or
any organic neurological disorders will not be considered for this protocol.