NCT00778856

Brief Summary

Organ transplantation has become the treatment of choice for most patients suffering end stage diseases of the kidney, pancreas, liver, heart or lung. Vascularized Composite Allotransplantation (VCA) {a.k.a. composite tissue allotransplantation} is the term used to describe transplantation of multiple tissues (skin, muscle, bone, cartilage, nerve, tendon, vessel) as a functional unit (e.g. hand). Several recent advances in clinical organ transplant immunosuppression and experimental limb VCA have now made it feasible to consider clinical VCA for the functional restoration of patients with loss of one or both hands. This protocol facilitates the development of limb VCA at the Atlanta Veterans Affairs Medical Center (VAMC) and at Emory University for patients with below the elbow amputations. It will evaluate the patients' use of transplanted limb(s) in activities of daily living and compare the function of the transplanted hand to the function with their previous prosthesis. Patients with below the elbow amputations will be enrolled. Donor tissue will be recovered from deceased donors following the guidelines of and in cooperation with the regional Organ Procurement Organization. The transplantation procedure and postoperative care will be performed using the standard technique for limb replantation. Patients will receive standard immunosuppressive regimen. Rejections will be treated in keeping with experience from the solid organ transplant experience. Graft failure will be treated with allograft amputation.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 7, 2008

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 24, 2008

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 27, 2015

Status Verified

March 1, 2015

Enrollment Period

4.5 years

First QC Date

October 7, 2008

Last Update Submit

March 26, 2015

Conditions

AmputationTransplantation

Outcome Measures

Primary Outcomes (1)

  • Ability-relative to prosthetic limbs-to use the transplanted limb in activities of daily living, measured by quantitative functional tests

    18 months

Secondary Outcomes (2)

  • Incidence of hand allograft rejection

    2 years

  • Development/presence of alloantibodies

    2 years

Study Arms (1)

Hand Transplant

EXPERIMENTAL
Procedure: Hand transplantation

Interventions

Hand transplantationPROCEDURE

allotransplantation of deceased donor composite tissue (hand and forearm)

Hand Transplant

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • male or female, 18-55 years of age, with below elbow amputation
  • ability to give informed consent

You may not qualify if:

  • Any condition that precludes serial follow-up.
  • Any active malignancy or any history of a hematogenous malignancy or lymphoma. Patients with primary, cutaneous basal cell or squamous cell cancers may be enrolled providing these are appropriately eliminated prior to transplant. For amputations due to malignancy, 5 years recurrence free survival will be required prior to enrollment.
  • Any known immunodeficiency syndrome.
  • Inability or unwillingness to comply with protocol monitoring and therapy, including, among others, a history of noncompliance, circumstances where compliance with protocol requirements is not feasible due to living conditions, travel restrictions, access to urgent medical services
  • Pregnancy or unwillingness to practice birth control methods during the first year of the study.
  • Unwillingness to undergo blood transfusion if clinically indicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Veterans Affairs Medical Center

Atlanta, Georgia, 30033, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Interventions

Hand Transplantation

Intervention Hierarchy (Ancestors)

Vascularized Composite AllotransplantationOrgan TransplantationTransplantationSurgical Procedures, OperativeTransplantation, Homologous

Study Officials

  • Linda C. Cendales, MD

    Emory University School of Medicine, VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 7, 2008

First Posted

October 24, 2008

Study Start

September 1, 2008

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

March 27, 2015

Record last verified: 2015-03

Locations

US(2)