Upper Extremity Injuries Clinical Trial
— HandCTAOfficial title:
Vascularized Composite Allotransplantation of the Hand
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | June 2019 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Kleinert Kutz and Associates/Jewish Hospital and St. Mary's Healthcare | Louisville | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Christina L. Kaufman PhD | Jewish Hospital and St. Mary's Healthcare, Kleinert, Kutz and Associates, U.S. Army Medical Research and Materiel Command, United States Department of Defense, University of Louisville |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | functioning allograft | Subjects will be monitored in Louisville for three months. After that subject will be monitored for function of the allograft on an annual basis or as clinical course indicates. We are requesting that subjects allow function to be evaluated on an annual basis for the life of the graft. | Monthly functional analysis for first three months and then on an annual basis for the life of the graft | |
Secondary | document and manage complications associated with Composite Tissue allotransplantation | Transplant recipients will have drug levels drawn weekly and then monthly until target blood levels of immunosuppression are acheived. We will then have blood drawn monthly and then quarterly as time progresses. We are requesting that subjects allow us to follow them for the life of the graft. | monthly labs for the first year, then bi-monthly for the first five years, or as clincial course indicates |
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