Actively Recruiting
Combined Craniomaxillofacial and Upper Extremity Allotransplantation
Led by NYU Langone Health · Updated on 2025-12-16
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying combined facial and upper extremity tissue transplants for patients who have not achieved satisfactory function, appearance, or sensation with conventional surgeries or prosthetics. This investigational surgery uses tissue from a non-living donor to restore these areas after severe injury. The study focuses on evaluating outcomes for those with injuries to the face, arm, forearm, and hand who have tried prosthetics when possible. The treatment involves a combined craniomaxillofacial and upper extremity allotransplantation procedure, which is a microvascular transplant of facial and upper limb tissue from a deceased donor. There is only one treatment group, and no placebo or control groups. Participants undergo this transplant surgery and then continue with follow-up evaluations. The study collects data on recovery, function, appearance, and sensation after the procedure. Participants are involved in regular clinical exams, x-rays, blood and tissue tests, and other assessments to monitor transplant function and appearance over time. These assessments occur monthly for the first 6 months, then every 6 months for 2 years, and annually up to 5 years. The study tracks changes in the function and appearance of the transplanted face and upper extremity segments to understand the outcomes and progress after surgery.
CONDITIONS
Brief Title
Craniomaxillofacial and Upper Extremity Allotransplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated all required Institutional Review Board (IRB) approved consent forms.
- Male or female aged 18 to 64 years.
- Facial tissue defect requiring transplantation including peri-oral, peri-orbital, or peri-nasal damage.
- Missing part of one or both hands and forearms.
- HIV negative at the time of transplant.
- Negative crossmatch at the time of transplant.
- Encouraged to seek second opinions from specialized plastic surgeons.
- Willing to participate in psychiatric, psychological, and social evaluations before and after transplant.
- Able to complete pre-transplant exams and screening.
- Approved for placement on the recipient waiting list.
- Willing to continue immunosuppression as directed.
- Able to attend follow-up visits as planned.
- Have autogenous tissue options available if graft failure occurs.
- Normal glomerular filtration rate (GFR) greater than 60.
- Negative pregnancy test within 48 hours of transplant for women of childbearing age and agree to use reliable contraception for one year after transplant.
You will not qualify if you...
- Uncontrolled infections or severe diseases excluding transplantation.
- Serious co-morbidities.
- Positive for HIV or Hepatitis B Antigen.
- Active cancer within 5 years except non-melanoma.
- Uncontrolled substance abuse.
- Body Dysmorphic Disorder.
- Severe active psychiatric illness.
- Cognitive impairments affecting consent.
- Recent medical non-adherence.
- Unstable housing or lack of supportive caregiver.
- Active smoking within the past year.
- Cognitive deficits from brain injury or neurological disorders.
- Psychological conditions that may affect transplant success or safety.
- Amputation above mid-humerus level.
- Congenital abnormalities affecting transplant outcomes.
- Amputation less than six months ago without prosthetic trial unless waived.
- Blindness affecting protective sensation in hand.
- Pregnancy.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - Up to discharge from hospital
Participants undergo the combined craniomaxillofacial and upper extremity allotransplantation surgery and receive immediate post-operative care.
1 hospitalization period including surgery and immediate care
Duration - Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
Participants attend follow-up visits for recovery assessments, including clinical exams, x-rays, blood and tissue tests, and other evaluations.
Monthly visits for 6 months, then visits every 6 months for 2 years, followed by annual visits up to 5 years
Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10017
Actively Recruiting
Research Team
T
Thomas Calahan, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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