Immunoclinical Phenotyping for Lung Transplant Rejection
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand why some people experience chronic lung problems after a lung transplant. By analyzing tissue, blood, and urine samples, researchers hope to identify bodily changes that lead to these issues. Individuals who received a lung transplant at the University of Virginia and are monitored for rejection problems might qualify for this study. Participants must be able to undergo MRI scans, so those who use oxygen continuously at home or have certain health restrictions may not qualify. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.
What prior data suggests that this protocol is safe for lung transplant patients?
Research shows that treatments in this type of study are usually in the early testing stages, meaning there is limited information about their safety for humans. However, reaching the second phase of research indicates that the treatment has passed some initial safety checks. These early studies aim to identify any side effects and assess how well participants tolerate the treatment.
This study involves extra tissue sampling from blood and urine. While common in research to better understand diseases, it might involve some risks, such as slight discomfort or minor bruising.
Prospective participants should ask the research team about any known side effects from the treatment and how they plan to monitor health during the study.
Why are researchers excited about this trial?
Unlike the standard of care for lung transplant rejection, which typically involves immunosuppressive drugs like tacrolimus or cyclosporine, the approach in this study is exciting because it focuses on immunoclinical phenotyping. This method aims to understand the patient's unique immune profile, allowing for more personalized treatment strategies. Researchers are hopeful that this approach can lead to better outcomes by tailoring therapies to the individual's immune response, potentially reducing rejection rates and improving overall transplant success.
What evidence suggests that this trial's methods could be effective for understanding CLAD?
Research in lung transplants has shown that chronic allograft rejection, where the body attacks the new lung, is a major issue. This condition, known as CLAD, affects many patients after their transplant. Although treatments exist to help manage rejection, understanding its causes remains a significant focus. Studies suggest that closely examining tissue and using advanced imaging can help doctors better understand the disease process. This understanding could lead to more effective ways to prevent or treat CLAD in the future.
Who Is on the Research Team?
Yun M Shim, MD
Principal Investigator
University of Virginia
Are You a Good Fit for This Trial?
This trial is for patients who have had a lung transplant at the University of Virginia and are part of their post-transplant rejection surveillance program. Participants must be clinically stable for MRI imaging, and those with additional illnesses like neurological or kidney diseases can join. However, individuals with certain conditions such as congenital heart disease, severe renal failure, large chest circumference, dependence on continuous oxygen, very low blood oxygen levels or lung function, claustrophobia, incompatible implants or devices for MRI scanning cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Registry Formation and Tissue Banking
Participants undergo routine surveillance bronchoscopy and extra tissue sampling of blood and urine for registry formation and tissue banking
Imaging and Phenotyping
Subgroup of patients characterized by hyper polarized gas MRI to enhance detection of CLAD and correlate imaging results with clinical/biochemical results
Follow-up
Participants are monitored for safety and effectiveness after registry formation and imaging
What Are the Treatments Tested in This Trial?
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Who Is Running the Clinical Trial?
University of Virginia
Lead Sponsor
National Institutes of Health (NIH)
Collaborator