Clinical trial NCT01269164: Face Transplantation Clinical Trial
Official title: Protocol for Composite Facial Allograft Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Facial Deformities
Keywords: Face Transplant
Facial Transplantation
Composite Facial Allograft Transplantation
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2011-01-04
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the success of the face transplant
timeFrame: Patients will be carefully screened and monitored post-operatively for signs of rejection or flap failure for 5 years.
Secondary outcomes:
measure: Evaluate tolerogenic properties of the immunosuppression protocol
timeFrame: Patients will be carefully screened and monitored post-operatively for signs of rejection or flap failure for 5 years.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Frank Papay, MD
role: PRINCIPAL_INVESTIGATOR
References: