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Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02310867
Recruitment Status : Recruiting
First Posted : December 8, 2014
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Linda Cendales, Duke University

Study Description
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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
Immunosuppression Drug: Belatacept Procedure: Hand transplant Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 2015
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Belatacept

Arms and Interventions
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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 Name: 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
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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. [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Clinical rejection [ Time Frame: 18 months ]
    Presence of macroscopic changes in the skin like a rash

  2. Histological rejection [ Time Frame: 18 months ]
    Presence of infiltrates categorized by the Banff classification


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310867


Contacts
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Contact: Linda Cendales, MD 919-681-7514 linda.cendales@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Linda Cendales
Investigators
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Principal Investigator: Linda Cendales, MD Duke University
More Information
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Responsible Party: Linda Cendales, Associate Professor of Surgery, Duke University
ClinicalTrials.gov Identifier: NCT02310867    
Other Study ID Numbers: Pro00056079
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Keywords provided by Linda Cendales, Duke University:
hand transplantation, amputation
Additional relevant MeSH terms:
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Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents