Status:
UNKNOWN
Vascularized Composite Allotransplantation of the Hand
Lead Sponsor:
Christina L. Kaufman PhD
Collaborating Sponsors:
Jewish Hospital and St. Mary's Healthcare
Kleinert, Kutz and Associates
Conditions:
Upper Extremity Injuries
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 amputa...
Detailed Description
At the Christine M. Kleinert Institute in Louisville, Kentucky, we are recruiting patients for a research protocol that is underway for Composite Tissue Allotransplantation of the Hand. This study is ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00711373
Start Date
June 1 1998
End Date
June 1 2019
Last Update
January 25 2018
Active Locations (1)
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1
Kleinert Kutz and Associates/Jewish Hospital and St. Mary's Healthcare
Louisville, Kentucky, United States, 40202