Recruiting
Phase 2

Vascularized Composite Allotransplantation

Sponsor:

Christina L. Kaufman PhD

Code:

NCT00711373

Conditions

Upper Extremity Injuries

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Allogeneic hand transplantation

Study Details

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 amputated hand. Recipients must currently take the same type of drugs as a kidney transplant patient to prevent rejection of the hand.

Conditions

Upper Extremity Injuries

Study ID

NCT00711373

Start date

Jun, 1998

Status verified date

Jan, 2018

Completion date

Jun, 2019

Anticipated

Primary completion date

Jun, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Unilateral and Bilateral Amputees

Interventions

Allogeneic hand transplantation

Surgical reconstruction of part or all of the hands and/or hands and forearm using tissue from a non-living donor

Primary outcome measure

  • functioning allograft [ Time Frame: Monthly functional analysis for first three months and then on an annual basis for the life of the graft ]

Central Contacts and Locations

Central contacts

Tuna Ozyurekoglu, MD

502-561-0352tozyurekoglu@cmki.org

Donna Stacy, RN

502-562-0313dstacy@cmki.org

Locations

Kleinert Kutz and Associates/Jewish Hospital and St. Mary's Healthcare

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Donna Stacy, RN

502-562-0313dstacy@cmki.org

Christina L Kaufman, PhD

502-562-0390ckaufman@cmki.org

Principal Investigator:

Chris Jones, MD

More Information

Sponsor

Christina L. Kaufman PhD

Last update posted

Jan 25, 2018

Last verified

Jan, 2018

Keywords

  • VCA
  • composite tissue allotransplantation
  • amputation
  • Hand

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Christina L. Kaufman PhD on 2018-01-25.