Summary: Lung transplant is an option for treating end-stage lung disease in cystic fibrosis (CF). In the United States, more people with CF and low lung function die each year than undergo lung transplant. More than half of people with CF who die without a lung transplant were never referred for consideration. Patient preference not to undergo lung transplant may account for 25-40% of decisions to defer r...

Summary: The goal of this clinical trial (non-pharmacologic, single-center) is to determine whether the Hering-Breuer inflation reflex is preserved-and how it is modulated by end-expiratory pressure-in adult intensive-care patients who have undergone bilateral lung transplantation. The study will enroll men and women ≥ 18 years admitted to the ICU during the early weaning phase and will include a compariso...

Summary: The goal of this Phase 3 clinical trial is to compare ARINA-1 (a nebulized immunomodulatory agent) plus Standard of Care vs Standard of Care alone. The main question it aims to answer are: * Evaluate the effectiveness of ARINA-1 in preventing bronchiolitis obliterans syndrome (BOS) progression in participants with a bilateral lung transplant * To evaluate the effectiveness of ARINA-1 on improving ...

Summary: This double-blind, randomized, placebo-controlled, multinational, multicenter, parallel-group, Phase 3, 2-arm, study will investigate the efficacy and safety of belumosudil compared with placebo, both administered on top of azithromycin and standard-of-care regimen of immunosuppression in male or female participants at least 1 year after bilateral lung transplant, who are at least 18 years of age ...

Summary: The goal of this pilot trial is to learn whether the use of cryo nerve block and its effect on sensation in the chest alters recovery after bilateral lung transplantation, and to which extent these parameters are influenced. As this study is setup as a pilot study, the main questions it aims to determine the potential impacted parameters as well as their effect sizes, of cryo-analgesia on both sho...

Summary: This is a trial in which 350 primary lung transplant recipients will be randomized (1:1) to receive either Tocilizumab (six doses over 20 weeks) plus standard triple maintenance immunosuppression or placebo (sterile normal saline) plus standard triple maintenance immunosuppression (Tacrolimus, Mycophenolate Mofetil, corticosteroids). The primary objective is to test the hypothesis that treatment w...

Summary: Adjuvant, non-live RSV vaccine will be administered to adult lung and allogeneic hematopoietic stem cell transplant recipients. The safety and immunogenicity of this intervention will be studied. Blood work will be collected before and after the intervention, to assess humoral and cellular immunity. Participants will be followed for adverse reaction, hospitalization, RSV breakthrough infection, gr...

Summary: By establishing a prospective, multicenter lung transplantation clinical cohort, this study aims to systematically evaluate the utility of cfDNA fragmentomics, peripheral blood single-cell sequencing, and proteomics in monitoring and predicting graft dysfunction after lung transplantation, and to develop a multi-omics predictive model for early identification, dynamic monitoring, and mechanistic i...

Summary: The aim of the study is to show that transplantation of lungs from Hepatitis B-infected donors is safe when using EVLP with UV light inactivation plus antivirals

Summary: Demonstrate the relationship between dd-cfDNA levels and HLA antibodies in blood transplant recipient and Demonstrate the Molecular Microscope® (MMDx) Diagnostic System results in indication and protocol biopsies from lung transplants.

Summary: This will be a follow-up study to the Comparison of High Dose vs. Standard Dose Influenza Vaccine in Lung Allograft Recipient study (DMID Protocol Number 22-0014) at Vanderbilt University Medical Center. Lung transplantation is a life-saving therapy for patients with advanced lung disease, and is also associated with an improvement in quality of life. However, due to the need for life-long immunos...

Summary: Clinical use of ex-vivo perfusion for lung transplantation. Collection, storage and processing of patient data for outcome analysis.