Actively Recruiting

Phase Not Applicable
Age: 18Years - 64Years
All Genders
NCT04057638

Craniomaxillofacial and Upper Extremity Allotransplantation

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

10

Participants Needed

1

Research Sites

341 weeks

Total Duration

On this page

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

Craniomaxillofacial and Upper Extremity Allotransplantation

Who Can Participate

Age: 18Years - 64Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated all required IRB-approved consent forms.
  • Male or female between 18 and 64 years old.
  • Facial composite tissue defect requiring facial transplantation as determined by surgeon.
  • Missing part of one or both hands and forearms.
  • HIV negative at time of transplant.
  • Negative crossmatch at time of transplant.
  • Encouraged to seek second opinions from specialized plastic surgeons for face and upper extremity reconstruction.
  • Willing to participate in psychiatric, psychological, and social evaluations before and after transplant.
  • Able to complete pre-transplant exams and screenings.
  • Approved by Patient Selection Committee for transplant waiting list.
  • Willing to continue immunosuppression as directed.
  • Able to attend follow-up visits as planned.
  • Have autogenous tissue options for reconstruction if graft fails.
  • Normal glomerular filtration rate (GFR) greater than 60.
  • Negative pregnancy test within 48 hours of transplant for women of childbearing age.
  • Agree to use reliable contraception for one year following transplant.
Not Eligible

You will not qualify if you...

  • Uncontrolled infection or severe diseases excluding transplantation.
  • Serious co-morbidities.
  • Positive HIV or Hepatitis B infection.
  • Active cancer within 5 years except non-melanoma.
  • Uncontrolled substance abuse.
  • Body Dysmorphic disorder.
  • Active severe psychiatric illness.
  • Cognitive limitations preventing informed consent.
  • Recent medical non-adherence.
  • Unstable housing or lack of supportive caregiver.
  • Smoking within the past year.
  • Cognitive deficits from traumatic brain injury or neurological disorders.
  • Psychological conditions hindering transplant success or safety.
  • Amputation above mid-humerus level.
  • Congenital abnormalities affecting transplant results.
  • Amputation less than six months ago without prosthetic trial unless waived.
  • Blindness affecting protective sensation in the hand.
  • Pregnancy.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

NYU Langone Health

New York, New York, United States, 10017

Actively Recruiting

Loading map...

Research Team

T

Thomas Calahan, BA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here