Craniomaxillofacial and Upper Extremity Allotransplantation Study

This study is testing a surgery called combined craniomaxillofacial and upper extremity allotransplantation, also known as a "combined face and upper extremity transplant." This procedure involves transferring tissue from a non-living donor to people who have severe injuries to their face and upper body (arm, forearm, and hand). The goal is to see if this surgery can restore better function, appearance, and sensation when previous surgeries and prosthetic devices haven't been successful. Researchers will look at how well the transplanted areas work and look over time. You may be able to join if you are between 18 and 64 years old, have severe facial and upper extremity injuries, and conventional treatments haven't worked. The study plans to enroll 10 participants, but its current status is unclear.

Study design: This is an interventional study that plans to enroll 10 participants. It is not specified if it is randomized or blinded.
What's involved: You would undergo the combined face and upper extremity transplant surgery. Recovery and outcomes will be observed through clinical exams, x-rays, blood and tissue tests, and other evaluations at follow-up visits.
Compensation: Not stated in the trial record.
Follow-up: Your function will be measured monthly for 6 months, every 6 months for 2 years, and then annually up to year 5 after the transplant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Craniomaxillofacial and Upper Extremity Allotransplantation

Recruiting

NAAges 18–64InterventionalTreatment

NYU Langone Health

~10 participants

Updated 2025-12-16 on ClinicalTrials.gov

What's tested:Combined Craniomaxillofacial and Upper Extremity Allotransplantation

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change in function of the transplanted facial segment

Measured over Monthly for 6 months, every 6 months for 2 years, then annually up to year 5

+11 more outcomes measured

Conditions

Face Injuries

Hand Injuries

Craniofacial Injuries

Upper Extremity Injuries

Facial Injuries

Facial Deformity

Where it's being run

1 sites across 1 states

New York1

Study leadership

Eduardo Rodriguez, MD, DDS · PRINCIPAL_INVESTIGATOR · NYU Langone Medical Center

Who to contact

Thomas Calahan, BA

[email protected]

(929) 455-5826

Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Signed and dated all required Institutional Review Board (IRB) approved consent forms.

Male or female recipient between the ages of 18-64 years. Recipients do not need to be of the same sex as the donor.

Facial composite tissue defect requiring facial transplantation as determined by the treating Plastic and Reconstructive Surgeon. Inclusive facial functional subunit tissue loss. Including but not limited to irreparable peri-oral, peri-orbital, and peri-nasal damage.

Missing part of one or both hands and forearms.

Must be HIV negative at the time of transplant.

Crossmatch is negative at the time of transplant.

Patient has been encouraged to seek a second opinion from a Plastic Surgeon with specialized focus in facial reconstruction.

Patient has been encouraged to seek a second opinion from a Plastic Surgeon with specialized focus in upper extremity reconstruction.

Willingness to participate in ongoing psychiatric, psychological and social work evaluations prior to and post-transplant surgery.

The subject is able to complete pre-transplant examination and screening procedures.

Patient has been approved by Patient Selection Committee for placement on the recipient waiting list.

The subject is willing to continue immunosuppression regimen as directed by treating physician.

Subject is willing and able to return to follow-up visits as described in treatment plan.

Subjects must have autogenous tissue options available for reconstruction in event of graft failure.

Normal glomerular filtration rate (GFR) \>60.

Negative pregnancy test within 48hrs of transplant for women of childbearing age and who agree to use a reliable form of contraception for one year following transplant.

Exclusion

Uncontrolled infection or severe concomitant diseases which would exclude the recipient from transplantation

Serious co-morbidities

Positive serology for HIV; Hepatitis B Antigen

Active malignancy within 5 years with the exclusion of non-melanoma

Substance abuse disorders not currently under control (as determined by the Michigan Alcohol Screening Test - see Appendix N.1: Subjects with a score of 3 or more will be excluded)

Body Dysmorphic disorder (see Appendix N.2 for screening tool). Less severe psychiatric conditions are addressed on a case by case basis

Active Severe Psychiatric Illness

Cognitive limitations affecting the patient's ability to provide informed consent

Recent history of medical non-adherence

Unstable social situation as evidence by lack of stable housing and/or lack of a supportive significant other.

Recent history of medical non-adherence.

Lack of stable housing and/or supportive significant other/caregiver throughout all phases of the study

Currently active smoker within 1 year

Subjects with any cognitive deficits related to a traumatic brain injury (TBI) and or any organic neurological disorders

Any other psychological status that would hinder the success or safety of the transplantation.

Level of amputation proximal to mid-humerus: some presence of proximal muscles is required to motor a functioning hand.

Congenital Abnormalities: co-existent absence/atrophy/agenesis of any tissue may affect post-transplant results

History of amputation of less than six months: subject must be allowed to attempt prosthetic use prior to hand transplantation. This can be waived in cases where the recipient requires amputation/revision of the transplant site at the time of transplantation. However, if at all possible, it is highly encouraged that the patient has ruled out prosthetics as an alternative to transplantation.

Blindness: blind amputees may be poor candidates because sensory return in the hand may not provide sufficient protective sensation

Pregnancy

What this trial measures

Change in function of the transplanted facial segmentMonthly for 6 months, every 6 months for 2 years, then annually up to year 5
This will be measured using electromyogram (EMG)
Change in function of the transplanted facial segmentMonthly for 6 months, every 6 months for 2 years, then annually up to year 5
This will be measured using nerve conduction studies (NCS)
Change in function of the transplanted facial segmentMonthly for 6 months, every 6 months for 2 years, then annually up to year 5
This will be measured using computerized tomography angiogram (CTA)
Change in function of the transplanted facial segmentMonthly for 6 months, every 6 months for 2 years, then annually up to year 5
This will be measured using magnetic resonance imaging (MRI)
Change in function of the transplanted facial segmentMonthly for 6 months, every 6 months for 2 years, then annually up to year 5
This will be measured using vision exams
Change in function of the upper extremity transplantMonthly for 6 months, every 6 months for 2 years, then annually up to year 5
This will be measured using pathology samples to check for rejection
Change in function of the upper extremity transplantMonthly for 6 months, every 6 months for 2 years, then annually up to year 5
This will be measured using electromyogram (EMG)
Change in function of the upper extremity transplantMonthly for 6 months, every 6 months for 2 years, then annually up to year 5
This will be measured using nerve conduction studies (NCS)
Change in function of the upper extremity transplantMonthly for 6 months, every 6 months for 2 years, then annually up to year 5
This will be measured using computerized tomography angiogram (CTA)
Change in function of the upper extremity transplantMonthly for 6 months, every 6 months for 2 years, then annually up to year 5
This will be measured using magnetic resonance imaging (MRI)
Change in appearance of the transplanted facial segmentMonthly for 6 months, every 6 months for 2 years, then annually up to year 5
This will be measured using photography
Change in appearance of the upper extremity transplantMonthly for 6 months, every 6 months for 2 years, then annually up to year 5
This will be measured using photography

Trialytics