RecruitingNot ApplicableNCT02476838

Hand Transplantation

Microvascular VCA Transplantation

Sponsor

NYU Langone Health

Enrollment

100 participants

Start Date

Jun 2, 2015

Study Type

INTERVENTIONAL

Conditions

Amputation

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

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria6

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 Criteria17

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