Face Transplantation Clinical Trial

NeuroTherapia, Inc.

Status

Completed

Conditions

Severe Facial Deformities

Treatments

Procedure: Surgical Procedure Composite Facial Transplant

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT01269164

IRB6914

Details and patient eligibility

About

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.

Full description

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.

Enrollment

3 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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