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Face Transplantation Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01269164
Recruitment Status : Active, not recruiting
First Posted : January 4, 2011
Last Update Posted : October 15, 2021
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Frank Papay, MD, The Cleveland Clinic

Tracking Information
First Submitted Date  ICMJE December 30, 2010
First Posted Date  ICMJE January 4, 2011
Last Update Posted Date October 15, 2021
Study Start Date  ICMJE July 2010
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2011)
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. ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2011)
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. ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Face Transplantation Clinical Trial
Official Title  ICMJE Protocol for Composite Facial Allograft Transplant
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Severe Facial Deformities
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Face Transplantation
Surgical Procedure Composite Facial Transplant
Intervention: Procedure: Surgical Procedure Composite Facial Transplant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 3, 2011)
2
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01269164
Other Study ID Numbers  ICMJE IRB6914
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Frank Papay, MD, The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE United States Department of Defense
Investigators  ICMJE
Principal Investigator: Frank Papay, MD The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP