Hand Transplantation

NCT02476838 | Recruiting DMC

• 1 other identifier: 15-00200
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Amputation

Keywords

hand injury; hand amputation; hand amputee; hand surgery

Outcome Measures

Primary Outcomes (1)

• Number and proportion of subjects with biopsy-proven rejection

  60 months

Secondary Outcomes (1)

• Number and proportion losing their VCA graft

  60 months

Study Arms (1)

traumatic amputation of the hand

OTHER

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

Procedure: Hand Transplantation

Interventions

Hand Transplantation PROCEDURE

microvascular VCA transplant

traumatic amputation of the hand

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Ambulatory Care Center

New York, New York, 10017, United States

RECRUITING

MeSH Terms

Conditions

Hand Injuries

Interventions

Hand Transplantation

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Vascularized Composite Allotransplantation; Organ Transplantation; Transplantation; Surgical Procedures, Operative; Transplantation, Homologous

Study Officials

• Sheel Sharma, MD

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Calahan

CONTACT

929-455-5826; thomas.calahan@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: June 19, 2015
• Study Start: June 2, 2015
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: November 3, 2025

Record last verified: 2025-10

Locations

US (1)