What is this study trying to find out about facial and upper extremity injuries?

This study is evaluating how well combined face and upper extremity transplants restore function, appearance, and sensation in people with severe injuries. It aims to learn if this surgery can improve outcomes when other surgeries and prosthetics have not worked. The research is sponsored by NYU Langone Health to better understand recovery after this transplant procedure.

Who may be eligible for this facial and upper extremity transplant clinical trial?

Adults aged 18 to 64 who have severe injuries to the face and upper extremities and have tried prosthetics when possible may be eligible. Participants must be HIV negative and willing to undergo psychological evaluations and follow-up visits. Please review eligibility criteria for more details.

Is there any cost to participate in this facial and upper extremity transplant clinical trial?

Study-related care, including the transplant surgery and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 64Years

All Genders

ID04057638

Surgical Transplant of Face and Upper Limb Tissue for Severe Injury Restoration Combined Craniomaxillofacial and Upper Extremity Allotransplantation Study

Led by NYU Langone Health · Updated on 2025-12-16

Participants Needed

Research Sites

N/A

Total Duration

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

Age: 18Years - 64Years

All Genders

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.

Research Team

Thomas Calahan, BA

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