Facial and Arm Transplant for Severe Injuries
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you must be willing to continue an immunosuppression regimen as directed by your treating physician.
Is facial and arm transplant surgery safe for humans?
How is the treatment for severe facial and arm injuries unique?
This treatment is unique because it involves transplanting multiple types of tissues, like skin and muscle, from a donor to a recipient as a single unit, which is not common in traditional reconstructive surgeries. It allows for the restoration of both appearance and function in cases of severe disfigurement, but requires lifelong medication to prevent rejection.56789
What data supports the effectiveness of the treatment Combined Craniomaxillofacial and Upper Extremity Allotransplantation?
Research shows that face and upper extremity transplants have been successful in restoring vital functions and appearance in patients with severe injuries. Nearly 50 hand transplants and 20 face transplants have been performed worldwide, demonstrating positive outcomes such as good aesthetic and functional results, and psychological acceptance by recipients.12567
Who Is on the Research Team?
Eduardo Rodriguez, MD, DDS
Principal Investigator
NYU Langone Medical Center
Are You a Good Fit for This Trial?
This trial is for adults aged 18-64 with severe facial and upper extremity injuries that haven't improved with standard surgery or prosthetics. Candidates must be HIV negative, have a normal kidney function, agree to contraception if applicable, and commit to psychiatric evaluations and follow-up visits. Exclusions include uncontrolled infections, serious illnesses, certain amputations, pregnancy, severe psychiatric issues or substance abuse disorders.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo microvascular VCA transplantation from a non-living donor to restore function, appearance, and sensation to the face and upper extremity
Follow-up
Participants are monitored for recovery and outcomes through clinical exams, x-rays, blood and tissue tests, and other evaluations
What Are the Treatments Tested in This Trial?
Interventions
- Combined Craniomaxillofacial and Upper Extremity Allotransplantation
Combined Craniomaxillofacial and Upper Extremity Allotransplantation is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
NYU Langone Health
Lead Sponsor