Face Transplantation Clinical Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by The Cleveland Clinic
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Marie Siemionow, M.D., Ph.D., The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01269164
First received: December 30, 2010
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Severe Facial Deformities
Procedure: Surgical Procedure Composite Facial Transplant

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Protocol for Composite Facial Allograft Transplant

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Evaluate the success of the face transplant [ Time Frame: Patients will be carefully screened and monitored post-operatively for signs of rejection or flap failure for 5 years. ] [ Designated as safety issue: No ]
    Demonstrate stable engraftment and restoration of facial skin/bone coverage and sensory-motor function in recipients of composite tissue allografts of vascularized skin, bone, and soft tissue augments(nose, ear, lips, eyelids, etc)under standard immunopression protocol.


Secondary Outcome Measures:
  • Evaluate tolerogenic properties of the immunosuppression protocol [ Time Frame: Patients will be carefully screened and monitored post-operatively for signs of rejection or flap failure for 5 years. ] [ Designated as safety issue: No ]
    Characterize tolerogenic properties of our immunosuppression protocol, by monitoring of donor specific chimerism and presence of T regulatory cells in the face allograft transplant recipients.


Estimated Enrollment: 2
Study Start Date: July 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Face Transplantation
Composite Facial Allograft Transplantation
Procedure: Surgical Procedure Composite Facial Transplant
Single Center Prospective Clinical Study to Document the Safety and Feasibility of the Surgical Procedure for Composite Facial Allograft Transplantation
Other Name: Face Transplant

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01269164

Contacts
Contact: Rebecca Algeri 216-445-3157 algerir@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Rebecca Algeri    216-445-3157    algerir@ccf.org   
Principal Investigator: Marie Siemionow, M.D., Ph.D.         
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Marie Siemionow, M.D., Ph.D. The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Marie Siemionow, M.D., Ph.D., The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01269164     History of Changes
Other Study ID Numbers: IRB6914
Study First Received: December 30, 2010
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Face Transplant
Facial Transplantation
Composite Facial Allograft Transplantation

Additional relevant MeSH terms:
Congenital Abnormalities
Facies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014