| NCT ID | NCT02476838 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Amputation |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2015-06-02 |
| Primary Completion | 2029-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2015-06-02 with a primary completion date of 2029-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Sheel Sharma, MD
PRINCIPAL INVESTIGATOR
NYU Langone Medical Center
Frequently Asked Questions
Who can join the NCT02476838 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Amputation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02476838 currently recruiting?
Yes, NCT02476838 is actively recruiting participants. Contact the research team at thomas.calahan@nyulangone.org for enrollment information.
Where is the NCT02476838 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT02476838 clinical trial?
NCT02476838 is sponsored by NYU Langone Health. The principal investigator is Sheel Sharma, MD at NYU Langone Medical Center. The trial plans to enroll 100 participants.