Background: The human face is critically important for breathing, eating, seeing, and
speaking/ communicating, but its most important job may be to look like a human face.
Devastating facial deformities often cause affected individuals to avoid human contact and
disappear from society. Although current surgical advancements can somewhat restore facial
defects, this process often requires many operations and the resulting face only resembles
the human face. To date, over 20 face transplants have been performed with highly encouraging
functional and aesthetic results, but widespread clinical use has been limited due to the
adverse effects of life-long and high-dose immunosuppression needed to prevent graft
rejection. Risks include infection, cancer, and metabolic problems, all of which can greatly
affect recipients' quality of life, make the procedure riskier, and jeopardize the potential
benefits of face transplantation.
Study Design: This non-randomized, Phase II clinical trial will document the use of a new
immunomodulatory protocol (aka - Pittsburgh Protocol, Starzl Protocol) for establishing face
transplantation as a safe and effective reconstructive treatment for devastating injuries/
defects by minimizing maintenance immunosuppression therapy in face transplant patients. This
protocol combines lymphocyte depletion with donor bone marrow cell infusion and has enabled
graft survival using low doses of a single immunosuppressive drug followed by weaning of
treatment. Initially designed for living-related solid organ donation, this regimen has been
adapted for use with grafts donated by deceased donors. The investigators propose to perform
15 full or partial human face transplants employing this novel protocol.
Specific Aims: 1) To establish face transplantation as a safe and effective reconstructive
strategy for the treatment of devastating facial injuries/defects; 2) To reduce the risk of
rejection and enable allograft survival while minimizing the requirement for long-term,
high-dose, multi-drug immunosuppression.
Significance of Research: Face transplantation could help injured individuals recover
functionality, self-esteem, and the ability to reintegrate into family and social life as
"whole" individuals. This protocol offers the potential for minimizing the morbidity of
maintenance immunosuppression, thereby beneficially shifting the risk/benefit ratio of this
life-enhancing procedure and enabling a wider clinical application of face transplantation.