Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy

Linda Cendales

Status and phase: Enrolling; Phase 2

Conditions: Immunosuppression

Treatments: Procedure: Hand transplant; Drug: Belatacept

Study type: Interventional

Funder types: Other

Identifiers

NCT02310867

Pro00056079

Details and patient eligibility

About

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).

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Hand transplant with Belatacept

Experimental group

Treatment:

Drug: Belatacept

Procedure: Hand transplant