Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy

Immunosuppression Clinical Trial

Official title:

Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02310867
• Other study ID #: Pro00056079
• Status: Recruiting
• Phase: Phase 2
• Start date: March 2015
• Est. completion date: June 2028

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: Linda Cendales, MD
• Phone: 919-681-7514
• Email: linda.cendales[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2028
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Immunosuppression

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Linda Cendales

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical rejection	Presence of macroscopic changes in the skin like a rash	18 months
Secondary	Histological rejection	Presence of infiltrates categorized by the Banff classification	18 months