Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT02476838

Hand Transplantation

Led by NYU Langone Health · Updated on 2025-11-03

100

Participants Needed

1

Research Sites

708 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to see if an investigational surgery that transfers tissue from a non-living donor to living individual will help restore greater function, appearance, and sensation to the hand and forearm areas of individuals who have suffered traumatic injury to the hand and forearm. This procedure is called a hand allotransplantation or "hand transplant". This study will also collect data on how patients do during and after having a hand transplant from a nonliving donor. Recovery and outcomes will be observed through clinical exams, x-rays, blood and tissue tests, and other associated evaluations at all follow up visits.

CONDITIONS

Official Title

Hand Transplantation

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Candidates may be male or female patients between the ages of 18 and 60 who are missing all or part of one or both hands and forearms
  • Must be HIV negative at the time of transplant
  • Crossmatch is negative between donor and recipient
  • Women of childbearing potential must have a negative pregnancy test within 48 hours of transplant and agree to use reliable contraception for one year following transplant
  • Subjects must give written informed consent
  • Subjects who are poor candidates for prosthesis and eligible for hand transplant due to prosthesis failure or poor satisfaction with trial of prosthesis
Not Eligible

You will not qualify if you...

  • Uncontrolled infection or severe concomitant diseases excluding recipient from transplantation
  • Substance abuse disorders not currently under control
  • Active severe psychiatric illness such as psychosis or depression
  • Body dysmorphic disorder
  • Positive serology for HIV or Hepatitis B/C antigen
  • Cognitive deficits related to traumatic brain injury or organic neurological disorders
  • Active malignancy within 5 years
  • Unstable social situation lacking stable housing or supportive significant other
  • Cognitive limitations affecting patient's ability
  • Recent history of medical nonadherence
  • Psychological status hindering transplantation success or safety
  • Level of amputation proximal to mid-humerus without sufficient proximal muscles
  • Congenital abnormalities affecting post-transplant results
  • History of amputation less than six months without prior prosthetic use attempt (waivers possible)
  • Blindness affecting protective sensation in hand
  • Pregnancy

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

NYU Langone Ambulatory Care Center

New York, New York, United States, 10017

Actively Recruiting

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Research Team

T

Thomas Calahan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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