Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy

Phase 2

Recruiting

• Conditions: Immunosuppression
• Interventions: Drug: Belatacept; Procedure: Hand transplant

• Registration Number: NCT02310867
• Lead Sponsor: Linda Cendales

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-04
• Study First Submitted QC: 2014-12-05
• Study First Posted: 2014-12-08
• Study Start: 2015-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02
• Primary Completion: 2027-12
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hand transplant with Belatacept	Hand transplant	-
Hand transplant with Belatacept	Belatacept	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Clinical rejection	18 months	Presence of macroscopic changes in the skin like a rash
Histological rejection	18 months	Presence of infiltrates categorized by the Banff classification

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States