RECRUITING

Hand Transplantation

Conditions

Amputation hand injury hand amputation hand amputee hand surgery

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Microvascular VCA Transplantation

Quick Facts

Study Start:2015-06-02

Study Completion:2029-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02476838

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Thomas Calahan

CONTACT

929-455-5826

thomas.calahan@nyulangone.org

Principal Investigator

Sheel Sharma, MD

PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center

Study Locations (Sites)

NYU Langone Ambulatory Care Center

New York, New York, 10017

United States

Collaborators and Investigators

Sponsor: NYU Langone Health

Sheel Sharma, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-06-02

Study Completion Date2029-01-01

Study Record Updates

Study Start Date2015-06-02

Study Completion Date2029-01-01

Terms related to this study

Keywords Provided by Researchers

hand injury
hand amputation
hand amputee
hand surgery

Additional Relevant MeSH Terms

Amputation