Hand transplants from deceased donors offer new hope for amputees
NCT ID NCT02476838
First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 2 times
Summary
This study is testing whether a hand transplant from a deceased donor can help people who have lost part or all of one or both hands and forearms regain better function, appearance, and feeling. Participants will receive the transplant surgery and be followed closely with exams, X-rays, and blood tests to monitor recovery and any signs of rejection. The study aims to improve quality of life for amputees, though lifelong medication to prevent rejection is required.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Started
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Jun 2015
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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NYU Langone Ambulatory Care Center
New York, New York, 10017, United States
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Other studies related to the condition(s) this trial covers.
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