Status:
RECRUITING
Craniomaxillofacial and Upper Extremity Allotransplantation
Lead Sponsor:
NYU Langone Health
Conditions:
Face Injuries
Hand Injuries
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
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...
Detailed Description
The purpose of this study is to see if an investigational surgery that transfers tissue from a non-living donor to a living individual will help restore greater function, appearance, and sensation to ...
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
Key Trial Info
Start Date :
June 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04057638
Start Date
June 17 2019
End Date
January 1 2026
Last Update
December 16 2025
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10017