Vascularized Composite Allotransplantation of the Hand
Status unconfirmed · Phase 2
Conditions studied: Upper Extremity Injuries
In brief
This is a clinical trial of unilateral and bilateral hand transplantation. This will be done by the surgical transfer of a hand from a non-living donor to restore function of non-functioning or amputated hand. Recipients must currently take the same type of drugs as a kidney transplant patient to prevent rejection of the hand.
Key facts
- Study ID
- NCT00711373
- Run by
- Christina L. Kaufman PhD
- People needed
- 20
- Starts
- 1998-06-01
- Expected to finish
- 2019-06-01
- Last updated by the study team
- 2018-01-25
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Candidates may be male or female patients between the ages of 18 and 65 who are missing all or part of a hand and forearm
- No serious co-existing medical or psycho-social problems
- 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
You may not qualify if…
- Uncontrolled infection or severe concomitant diseases which would exclude the recipient from transplantation
- Alcoholism not currently under control
- Malignancy
- Excessive proximal level of amputation: 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
- Blindness: blind amputees may be poor candidates because sensory return in the hand may not provide sufficient protective sensation
- Pregnancy
Where it is running
- Kleinert Kutz and Associates/Jewish Hospital and St. Mary's Healthcare — Louisville, Kentucky, United States (enrolling)
Full record on ClinicalTrials.gov
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