RECRUITING

Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy

Quick Facts

Study Start:2015-03
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02310867

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients from 18-65 years old with loss of limb
  2. 2. Willingness and legal ability to give informed consent
  3. 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
  1. * Any condition that precludes serial follow-up
  2. * Any condition that would likely increase the risk of protocol participation or confound the interpretation of the data
  3. * Any active malignancy or any history of a malignancy or lymphoma
  4. * Inability or unwillingness to comply with protocol monitoring and therapy and immunodeficiency syndrome(s)

Contacts and Locations

Study Contact

Linda Cendales, MD
CONTACT
919-681-7514
linda.cendales@duke.edu

Principal Investigator

Linda Cendales, MD
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

Duke University Medical Center
Durham, North Carolina, 27710
United States

Collaborators and Investigators

Sponsor: Linda Cendales

  • Linda Cendales, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-03
Study Completion Date2028-06

Study Record Updates

Study Start Date2015-03
Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

  • hand transplantation, amputation

Additional Relevant MeSH Terms

  • Immunosuppression