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New treatment option for Amputation
Official title Hand Transplantation
ClinicalTrials.gov ID: NCT02476838
What this study is testing
- What it's testing
- 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".
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join 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...
- people must give written informed consent
You likely can't join 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
See the full eligibility 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
- people must give written informed consent
- people 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
- people 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...
- Blindness: blind amputees may be poor candidates because sensory return in the hand may not provide sufficient protective sensation
- Pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.