RecruitingNot ApplicableNCT04057638

Craniomaxillofacial and Upper Extremity Allotransplantation

Combined Craniomaxillofacial and Upper Extremity Allotransplantation


Sponsor

NYU Langone Health

Enrollment

10 participants

Start Date

Jun 17, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate functional and aesthetic outcomes of combined facial and upper extremity composite tissue allografts on patients who have not achieved functional and aesthetic outcomes with conventional reconstructive surgical strategies and prosthetic devices.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

Face transplantation and hand/forearm transplantation are complex reconstructive procedures for people who have suffered severe disfigurement or limb loss. This study at a specialized medical center follows patients who receive craniomaxillofacial (face and upper jaw) composite tissue transplants and/or upper extremity (hand and forearm) transplants. The goal is to evaluate surgical outcomes, immune suppression management, and quality of life over the long term. Candidates must be adults aged 18–64 with documented facial tissue loss or hand/forearm amputation, be HIV-negative, be psychologically stable, and have autogenous (natural tissue) backup options in case of graft failure. Extensive psychiatric screening, social stability assessment, and committee approval are required. Active smokers, blind individuals, and pregnant women are excluded. You may be eligible if: - You are between 18 and 64 years old - You have a facial composite tissue defect requiring facial transplantation, OR you are missing part of one or both hands/forearms - You are HIV negative and have a negative crossmatch - You have a stable social situation with a support person available throughout the study - You have stable housing and no history of substance abuse disorders currently out of control You may NOT be eligible if: - You have HIV, active Hepatitis B (surface antigen positive), or active malignancy within the past 5 years - You are a current smoker (within the past year) - You have active severe psychiatric illness or body dysmorphic disorder - You are blind - Your amputation was less than 6 months ago (without a waiver) - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURECombined Craniomaxillofacial and Upper Extremity Allotransplantation

Combined Craniomaxillofacial and Upper Extremity Allotransplantation


Locations(1)

NYU Langone Health

New York, New York, United States

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NCT04057638


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