Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy

Study Overview
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Brief Summary
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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
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Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy

Conditions
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Immunosuppression

Intervention / Treatment
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* Drug: Belatacept
* Procedure: Hand transplant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients from 18-65 years old with loss of limb Willingness and legal ability to give informed consent 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hand transplant with Belatacept<br> | Drug: Belatacept<br>* 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.<br>* Other names: Nulojix;Procedure: Hand transplant<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical rejection | Presence of macroscopic changes in the skin like a rash | 18 months | 
| Histological rejection | Presence of infiltrates categorized by the Banff classification | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hand transplantation, amputation