Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy

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).

Study Overview

• Status: Recruiting
• Conditions: Immunosuppression
• Intervention / Treatment: Drug: Belatacept; Procedure: Hand transplant

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Linda Cendales, MD; Phone Number: 919-681-7514; Email: linda.cendales@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Hand transplant with Belatacept

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.; Other Names: Nulojix; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Linda Cendales
• Investigators: Principal Investigator: Linda Cendales, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: December 4, 2014
• First Submitted That Met QC Criteria: December 5, 2014
• First Posted (Estimated): December 8, 2014

Study Record Updates

• Last Update Posted (Actual): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: hand transplantation, amputation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Abatacept
• Other Study ID Numbers: Pro00056079

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No