Hand transplantation for individuals with traumatic hand injuries
Microvascular VCA Transplantation
This study is testing if hand transplants can help people aged 18 to 60 who have lost their hands or forearms due to injuries regain function, appearance, and feeling in those areas.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT02476838 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of hand allotransplantation, a surgical procedure that transfers tissue from a deceased donor to individuals who have suffered traumatic hand and forearm amputations. Participants aged 18 to 60 will undergo a thorough screening process to determine their eligibility for the transplant waiting list. The study aims to assess the restoration of function, appearance, and sensation in the affected areas through clinical evaluations and follow-up assessments. Data collected will include clinical exams, x-rays, and blood tests to monitor recovery and outcomes post-transplant.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 who have experienced traumatic amputation of the hand or forearm and are dissatisfied with conventional prostheses.
Not a fit: Patients with uncontrolled infections, severe psychiatric illnesses, or substance abuse disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this procedure could significantly improve the quality of life for patients by restoring hand function and sensation.
How similar studies have performed: Other studies on hand transplantation have shown promising results, indicating that this approach is gaining traction in the medical field.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- NYU Langone Ambulatory Care Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Sheel Sharma, MD — NYU Langone Medical Center
- Study coordinator: Thomas Calahan
- Email: thomas.calahan@nyulangone.org
- Phone: 929-455-5826
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.