Hand Transplantation for Amputation

This study is investigating hand transplantation, a surgery that transfers tissue from a non-living donor to a living individual. The goal is to see if this procedure can help people who have lost all or part of one or both hands and forearms regain better function, appearance, and feeling. Researchers will also collect information on how patients recover and what their outcomes are after the transplant. You may be able to join if you are between 18 and 60 years old, are missing part of your hand or forearm due to injury, and are HIV negative. The study will measure how many people experience biopsy-proven rejection (when the body's immune system attacks the new hand) over 60 months.

Study design
This is an interventional study planning to enroll 100 participants. It is designed to evaluate the effects of hand transplantation.
What's involved
You would undergo pre-transplant screening procedures and evaluations, which are re-evaluated yearly if you are on the waiting list. If on the waitlist, you would provide serum samples monthly for cross-matching.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 60 months to monitor for biopsy-proven rejection.

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NCT02476838

Hand Transplantation

Withdrawn
NAAges 18–60Interventional
NYU Langone Health
Updated 2026-08-31 on ClinicalTrials.gov
What's tested:Hand Transplantation

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number and proportion of subjects with biopsy-proven rejection
Measured over 60 months
Amputation
1 sites across 1 states
New York1
  • Sheel Sharma, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Medical Center

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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 who are of child bearing potential must have a negative pregnancy test (urine test is acceptable) 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 - prosthesis failure or non acceptance/poor satisfaction with trial of prosthesis

Exclusion

Uncontrolled infection or severe concomitant diseases which would exclude the recipient from transplantation
Substance abuse disorders not currently under control (as determined by the Michigan Alcohol Screening Test)
Active severe psychiatric illness such as Psychosis or Depression
Body Dysmorphic disorder (see Appendix K for screening tool). Less severe psychiatric conditions are addressed on a case by case basis
Co-existing medical or psycho-social problems relevant to tissue allotransplantation:
Positive serology for HIV; Hepatitis B/C Antigen
Subjects with any cognitive deficits related to a TBI (traumatic brain injury) and or any organic neurological disorders
Active malignancy within 5 years
Unstable social situation as evidenced by lack of stable housing and/or lack of a supportive significant other
Cognitive limitations affecting patients ability
Recent history of medical nonadherence
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
  • Number and proportion of subjects with biopsy-proven rejection60 months