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Immunosuppressant

Hand Transplant + Belatacept for Limb Loss Therapy

Phase 2
Recruiting
Led By Linda Cendales, MD
Research Sponsored by Linda Cendales
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willingness and legal ability to give informed consent
Patients from 18-65 years old with loss of limb
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Study Summary

This trial is testing the safety and efficacy of hand transplants for people who have lost their limbs below the elbow. The primary endpoint is the ability to use the transplanted limb in activities of daily living at 18 months after transplantation, as measured by a quantitative functional test.

Who is the study for?
This trial is for individuals aged 18-65 who have lost a limb below the elbow and are willing to give informed consent. Participants must be able to travel to the study site or send samples by mail. People with conditions that affect follow-up, increase risk, or confound data interpretation, active malignancies, unwillingness to comply with monitoring and therapy, or immunodeficiency syndromes cannot join.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of hand transplants using Belatacept for immunosuppression in patients with limb loss. The main goal is assessing if patients can use their new hand for daily activities after 18 months. It involves visits over this period for various evaluations including blood tests and biopsies.See study design
What are the potential side effects?
Risks include rejection of the transplanted hand and infection risks due to immunosuppression. Procedures like blood draws and biopsies carry additional risks along with potential breaches in confidentiality despite electronic security measures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing and legally able to agree to participate.
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I am between 18 and 65 years old and have lost a limb.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ability to use the tranplanted limb in activities of daily living at 18 months following transplantation measured by a quantitative functional test.
Secondary outcome measures
Clinical rejection
Histological rejection

Trial Design

1Treatment groups
Experimental Treatment
Group I: Hand transplant with BelataceptExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belatacept
2013
Completed Phase 4
~2210

Find a Location

Who is running the clinical trial?

Linda CendalesLead Sponsor
1 Previous Clinical Trials
5 Total Patients Enrolled
Linda Cendales, MDPrincipal Investigator - Duke University
Duke University Health System Inc, Duke University Hospital
1 Previous Clinical Trials
5 Total Patients Enrolled

Media Library

Belatacept (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT02310867 — Phase 2
Immunosuppression Research Study Groups: Hand transplant with Belatacept
Immunosuppression Clinical Trial 2023: Belatacept Highlights & Side Effects. Trial Name: NCT02310867 — Phase 2
Belatacept (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02310867 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy
Linda Cendales 2015. "Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02310867.
All > North Carolina
~14 spots leftby Dec 2027
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