Face Transplantation Clinical Trial

The human scalp and face define two important body units, both functionally and
aesthetically. Traumatic deformities of the head and neck region resulting from burn
injuries, gun shot wounds, or ablative tumor surgeries may involve the defect of the skin,
subcutaneous tissue, muscle or the combination of all these elements. In most cases, the
ideal reconstruction is very difficult to achieve. Sometimes, a major part of face along
with the ear or the nose may be involved. The extensive scalp loss due to burn or avulsion
injury is another deforming and psychologically debilitating condition presenting as a major
reconstructive challenge. An ideal reconstructive procedure should replace the missing
tissues and restore the motor and sensory function. Traditional reconstructive procedures of
facial deformities involve skin grafting, local flap applications, tissue expansion, and
prefabrication as well as free tissue transfers. The primary goal during facial
reconstruction is restoration of the function and aesthetic appearance. To obtain
satisfactory results, missing parts should be replaced only by tissues of the same color and
texture. The purpose of this study is to apply human facial allograft transplant to the
subjects with severe facial deformities or disfigurements in order to provide adequate
coverage, aesthetic appearance and functional outcome.

Inclusion Criteria:

- Subject must be willing to sign the informed consent and agree to all follow up
procedures, including the realistic understanding of the impact of face
allotransplantation on their lifestyle

- Subjects will be evaluated by plastic surgeon to assess indications for facial
allotransplantations based on severity and complexity of facial deformity

- Subjects ages 18-60.

- Subject must be willing to undergo a psychiatric and social services
pre-transplantation evaluation

- Subject must be willing to undergo major face surgery

- Subject must be a candidate for general anesthesia

- Subjects must be willing to comply with post transplant physical therapy.

- Subject must be willing and able to receive potent drugs to induce and maintain
immunosuppression and follow the infection prophylaxis protocol

- Subject must be willing to receive standard vaccinations such as influenza,
pneumococcus, and hepatitis B.

- Subjects must be free of malignant tumors for 5 or more years with the exception of
certain skin cancer.

Exclusion Criteria:

- Subject that shows history of persistent non-compliance

- Findings of the psychiatric evaluation that may indicate non-compliance or mental
instability

- Presence of an active infection including Human Immunodeficiency Virus, mycobacteria,
hepatitis B, and hepatitis C

- Presence of an occult infection for example, dental abscess, UTI, tuberculosis, or
history of systemic/occult infection within 3 months of surgery

- Any current Chemical Dependency including alcohol

- Subjects at high risk for the recurrence of malignancy with the exception of certain
skin cancers

- Any diagnosis that the qualifying plastic surgeon feels would put the subject at high
risk for the surgical procedure of face transplantation

- Subjects who do not have adequate donor site tissue available for coverage in the
event of face transplant failure