Recruiting

Allotransplantation

Sponsor:

NYU Langone Health

Code:

NCT04057638

Conditions

Face Injuries

Hand Injuries

Craniofacial Injuries

Upper Extremity Injuries

Facial Injuries

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Combined Craniomaxillofacial and Upper Extremity Allotransplantation

Study Details

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 outcomes with conventional reconstructive surgical strategies and prosthetic devices.

Conditions

Face Injuries

Hand Injuries

Craniofacial Injuries

Upper Extremity Injuries

Facial Injuries

Study ID

NCT04057638

Start date

Jun 17, 2019

Status verified date

Dec, 2025

Completion date

Jan 1, 2026

Anticipated

Primary completion date

Jan 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

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
  • Pregnancy

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment group

There will only be the treatment group in this study, which undergoes microvascular VCA transplantation. There will be no randomization, placebo or control groups.

Interventions

Combined Craniomaxillofacial and Upper Extremity Allotransplantation

Combined Craniomaxillofacial and Upper Extremity Allotransplantation

Primary outcome measure

  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Thomas Calahan, BA

(929) 455-5826Thomas.Calahan@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10017

Contacts

Elie Ramly, MD

929-455-5824Elie.Ramly@nyulangone.org

Thomas Calahan, BA

9294555826Thomas.Calahan@nyulangone.org

Principal Investigator:

Eduardo Rodriguez, MD, DDS

More Information

Sponsor

NYU Langone Health

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Keywords

  • Transplants
  • Transplantation
  • Craniomaxillofacial Transplantation
  • Upper Extremity Transplantation
  • Vascularized Composite Allotransplantation (VCA)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2025-12-16.