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Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy

RecruitingPhase 2Ages 18 Years - 65 YearsAllLinda Cendales
NCT02310867 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 potent

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📋 Eligibility rules (as published)
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)
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What it tests

  • Belatacept
  • Hand transplant
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Where

1 site
Duke University Medical Center
Durham, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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