Status:
COMPLETED
Face Transplantation
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Transplantation: Facial Transplantation
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
This study aims to: 1. Perform face transplants on people who have suffered severe facial trauma with tissue and functional loss; and 2. Evaluate the acceptance and function of the transplanted tissu...
Detailed Description
For patients with severe facial deformities or facial wounds from traumatic injuries, we would like to pursue the use of a face transplant to help reconstruct a person's damaged face. Our goal is to n...
Eligibility Criteria
Inclusion
- 18-64 years of age
- Facial defect or injury requiring facial transplantation as determined by the treating Plastic and Reconstructive Surgeon
- Signed written informed consent
- Able to complete psychiatric evaluations
- Willing and able to continue immunosuppression regimen as directed by treating physician
- Willing and able to return for follow-up visits as described in the treatment plan
- Must have autogenous tissue options available for reconstruction in event of graft failure
- Laboratory values as defined by research protocol
- Willing to undergo review by Participant Selection Committee and be placed on a transplant recipient waitlist
Exclusion
- Pre-existing disease that would exclude the recipient from transplantation
- Active infection
- Ongoing substance abuse
- HIV positive
- Positive for Hepatitis B or C
- Active malignancy
- Pregnant or breastfeeding
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2020
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01140087
Start Date
September 1 2010
End Date
August 14 2020
Last Update
September 30 2021
Active Locations (1)
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1
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201