Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2028-06-30

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).

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Detailed Description

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Conditions

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Immunosuppression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hand transplant with Belatacept

Group Type EXPERIMENTAL

Belatacept

Intervention Type DRUG

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.

Hand transplant

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type PROCEDURE

Other Intervention Names

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Nulojix

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No