Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy

Sponsor
Linda Cendales (Other)
Overall Status
Recruiting
CT.gov ID
NCT02310867
Collaborator
(none)
50
1
1
93
0.5

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the safety and efficacy of hand transplantation as a treatment for patients with loss of limb below the elbow, The study will focus on patients who have had loss of limb. The primary endpoint is the ability to use the tranplanted limb in activities of daily living at 18 months following transplantation measured by a quantitative functional test.

Study activities include several study visits over 18 months and include; demographics, medical history, vital signs, psychosocial evaluation, urine, blood test, chest x-ray, bone density scans, and biopsies. Subjects who are 18-65 and willing to travel to site and have loss of limb will be included in study evaluation.

Risks of the study include risk of rejection and infection after being transplanted. Additional risk are associated with procedures that include blood draws, biopsies, x-rays, and potential loss of confidentiality. All patient data will be kept electronically and in accordance with the requirements of Duke University. In addition to the experimental data, this database includes recipient and donor demographics and transplant relevant medical history, range of motion, sensation, and immunosuppressive medications. Data will be recorded and reported in accordance with the standards required by the United Network for Organ Sharing (UNOS).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy
Actual Study Start Date :
Mar 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hand transplant with Belatacept

Drug: Belatacept
This study will also test a new immunosuppressant drug called Nulojix® (belatacept) to see if it is able to prevent rejection in a hand transplant. Nulojix® (belatacept) is approved by the FDA for use in kidney transplants; however, it is investigational in this study.
Other Names:
  • Nulojix
  • Procedure: Hand transplant
    The purpose of this study is to see if a surgical procedure for transplantation of a hand from a deceased donor can help subjects perform daily living activities better than they are currently able to do.

    Outcome Measures

    Primary Outcome Measures

    1. Ability to use the tranplanted limb in activities of daily living at 18 months following transplantation measured by a quantitative functional test. [18 months]

    Secondary Outcome Measures

    1. Clinical rejection [18 months]

      Presence of macroscopic changes in the skin like a rash

    2. Histological rejection [18 months]

      Presence of infiltrates categorized by the Banff classification

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Patients from 18-65 years old with loss of limb

    2. Willingness and legal ability to give informed consent

    3. Willingness to travel to study site for protocol specific samples to be taken, or in some cases, the ability to send samples via overnight mail

    Exclusion Criteria:
    • Any condition that precludes serial follow-up

    • Any condition that would likely increase the risk of protocol participation or confound the interpretation of the data

    • Any active malignancy or any history of a malignancy or lymphoma

    • Inability or unwillingness to comply with protocol monitoring and therapy and immunodeficiency syndrome(s)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Duke University Medical Center Durham North Carolina United States 27710

    Sponsors and Collaborators

    • Linda Cendales

    Investigators

    • Principal Investigator: Linda Cendales, MD, Duke University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Linda Cendales, Associate Professor of Surgery, Duke University
    ClinicalTrials.gov Identifier:
    NCT02310867
    Other Study ID Numbers:
    • Pro00056079
    First Posted:
    Dec 8, 2014
    Last Update Posted:
    Jan 19, 2022
    Last Verified:
    Jan 1, 2022
    Keywords provided by Linda Cendales, Associate Professor of Surgery, Duke University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 19, 2022