NCT00711373

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 1998

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1998

Completed
10.1 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 8, 2008

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

21 years

First QC Date

July 7, 2008

Last Update Submit

January 23, 2018

Conditions

Upper Extremity Injuries

Keywords

VCAcomposite tissue allotransplantationamputationHand

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • document and manage complications associated with Composite Tissue allotransplantation

    monthly labs for the first year, then bi-monthly for the first five years, or as clincial course indicates

Study Arms (1)

Unilateral and Bilateral Amputees

EXPERIMENTAL
Procedure: Allogeneic hand transplantation

Interventions

Allogeneic hand transplantationPROCEDURE

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

Unilateral and Bilateral Amputees

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Louisville, Kentucky, 40202, United States

RECRUITING

Related Links

Study Officials

  • Chris Jones, MD

    Jewish Hospital Transplant Center

    PRINCIPAL INVESTIGATOR

  • Tuna Ozyurekoglu, MD

    Christine M. Kleinert Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuna Ozyurekoglu, MD

CONTACT

502-561-0352tozyurekoglu@cmki.org

Donna Stacy, RN

CONTACT

502-562-0313dstacy@cmki.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Exec. Director

Study Record Dates

First Submitted

July 7, 2008

First Posted

July 8, 2008

Study Start

June 1, 1998

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

January 25, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)