NCT02310867

Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Linda Cendales · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Immunosuppression

Interventions

Type	Name	Description
DRUG	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.
PROCEDURE	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.

Timeline

• Start date: 2015-03-01
• Primary completion: 2027-12-01
• Completion: 2028-06-01
• First posted: 2014-12-08
• Last updated: 2026-04-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study