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Hand Transplantation

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ClinicalTrials.gov Identifier: NCT02476838
Recruitment Status : Not yet recruiting
First Posted : June 19, 2015
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

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.


Condition or disease Intervention/treatment Phase
Amputation Procedure: Hand Transplantation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Microvascular VCA Transplantation
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
traumatic amputation of the hand
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
microvascular VCA transplant




Primary Outcome Measures :
  1. Number and proportion of subjects with biopsy-proven rejection [ Time Frame: 60 months ]

Secondary Outcome Measures :
  1. Number and proportion losing their VCA graft [ Time Frame: 60 months ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02476838


Contacts
Contact: Nicole Sweeney, NP (646) 501-4464 Nicole.Sweeney@nyumc.org
Contact: Tiffany Drummond 212-263-4867 tiffany.drummond@nyumc.org

Sponsors and Collaborators
New York University School of Medicine

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02476838     History of Changes
Other Study ID Numbers: 15-00200
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by New York University School of Medicine:
hand injury
hand amputation
hand amputee
hand surgery