NCT04057638 · NYU Langone Health
Craniomaxillofacial and Upper Extremity Allotransplantation
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Combined Craniomaxillofacial and Upper Extremity Allotransplantation
Combined Craniomaxillofacial and Upper Extremity Allotransplantation
Primary outcome measures
Change in function of the transplanted facial segment
Time frame: Monthly 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 segment
Time frame: Monthly 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 segment
Time frame: Monthly 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 segment
Time frame: Monthly 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 segment
Time frame: Monthly 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 transplant
Time frame: Monthly 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 transplant
Time frame: Monthly 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 transplant
Time frame: Monthly 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 transplant
Time frame: Monthly 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 transplant
Time frame: Monthly 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 segment
Time frame: Monthly 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 transplant
Time frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
This will be measured using photography
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 16, 2025 · Source of record for eligibility and locations