Clinical Trials

The purpose of this trial is to establish whether an organ preservation strategy maintaining donor lung at the temperature of 10°C for prolonged period of times (12-24hs) is safe and provide outcomes similar to the conventional preservation in ice cooler. 

The objective of this study is to 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 and who have evidence of progressive CLAD despite azithromycin therapy.

The purpose of this study is to to mechanistically investigate the effect of specific inspiratory muscle training on respiratory function, exercise capacity, health-related quality-of-life, and short-term clinical outcomes in patients after lung transplant.

The purpose of this study is to explore adherence, barriers, side effects, and preference for pharmacologic antifungal prophylaxis following lung transplant. 

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 quality of life decline and preventing or delaying the use of augmented immunosuppression in participants with pre-BOS relative to SOC.

Participants will have clinic visits at screening, randomization (day 1) and weeks 4, 12, 18, and 24. After week 24, participants ...

This is a safety study to compare the safety of receiving a lung treated with the Toronto EVLP System™ by SPONSOR in SPONSOR's dedicated facility against standard lung transplantation.

The purpose of this study is to develop non-invasive diagnostics for lower respiratory tract colonization and invasion by Pseudomonas aeruginosa (PA), one of the most serious infections in hospitals.

The purpose of this study is to evaluate the safety and effectiveness of the Centralized Lung Evaluation System (CLES) in enabling evaluation of potential donor lungs not otherwise used for transplant into subjects with end stage, survival-limiting lung disease in need of lung transplantation. This will be accomplished by evaluating subject survival at the later of 6 months or hospital discharge post-transplant.

A normal lung ultrasound artifact pattern in an aymptomatic lung transplant recipient with normal chest radiograph and spirometry can safely exclude significant acute cellular rejection.

The purpose of this study is to establish a Lung Transplant Repository for current and future research.  This will facilitate our understanding of obliterative bronchiolitis and ultimately lead to better preventive and therapeutic strategies.

The purpose of this study is to investigate ghrelin, a peptide that mechanistically carries the promise of therapeutics benefit for diverse aspects of morbidity associated with lung transplantation.

The aim of this study is to evaluate a novel NGS-based assay for early detection of increased amounts of dd-cfDNA and its correlation to acute graft rejection and development of chronic lung allograft dysfunction (CLAD), and to improve the rejection diagnostics of patients after transplantation in order to empower early clinical intervention and thereby prolong the potential survival of the graft.

This study is being done to develop a serum and tissue bank for future research of patients with heart failure, mechanical circulatory support and/or cardiothoracic transplants. This blood/tissue will be used for three principle purposes: (1) laboratory tests which will be available in the future but that are not currently available and which may be of benefit to the patient, (2) review of previous patient laboratory results made necessary by development of a new disease process by the patient, and (3) future unspecified research purposes.

The purpose of this retrospective and prospective study is to evaluate tissue bank from donors and recipients who underwent heart and lung transplant in order to study the Role of Mitochondrial DNA in Encoding Histocompatibility Antigens in humans and rejection.

Currently transplant caregivers are viewed as healthy volunteers caring for patients following heart or lung transplant. However research has revealed that thoracic transplant caregivers have increased mood disorders, distress, and high caregiver burden, especially while caring for patients on the organ transplant waiting list. By monitoring caregiver traits and behaviors we will be better able to provide care and services for CG to improve both CG and patient outcomes.

Ability to adhere to complex medical regimens is critical to achieving successful transplant outcomes, as non-adherent patients suffer graft failure and death following transplantation. Since potential recipients greatly exceed organ availability, identification of candidates who will adhere to complex post-transplant regimens is critically important and emphasized by practice guidelines. When selecting candidates for transplant, physicians try to subjectively predict post-transplant adherence because, although tools exist to measure current adherence, tools that reliably predict future adherence are lacking. Despite rigorous medical and psychosocial screening pretransplant, non-adherence rates are high following transplant. Therefore, the current approach for predicting future non-adherence is suboptimal, ...

The purpose of this study is to monitor patient's oral intake weekly for one month after transplant and to determine the modifiable nutritional risk factors.

To create a biorepository of fluid [lung lavage], blood and tissue specimens [explanted diseased lung tissue from the recipient and serial lung biopsy specimens after transplant] for future studies.

The purpose of this study is to determine if DNA originating from the transplanted heart or lung can be detected in the blood and used to monitor for rejection.

The purpose of this study is to 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.

The purpose of this study is to evaluate patient acceptance to participate, retention, feasibility of randomization, and acceptability and compliance with a novel 12-week, home-based, multimodal prehabilitation program in waitlisted lung transplant candidates.

The purpose of this study is to:

• Demonstrate pharmacogenetic variability in the Mayo Clinic Florida lung transplant population.
• Describe patterns in tacrolimus levels in the context of pharmacogenomic profiles
• Use pharmacogenomic data to establish a need for therapeutic drug monitoring in selected other drugs
• Use pharmacogenomic data, in combination with knowledge of drug interactions, to establish sensitivity to tacrolimus dose changes

The purpose of this study is to longitudinally follow Torque Teno Virus (TTV) levels in lung transplant recipients and attempt to find a correlation with infection or rejection events.

The purpose of this study is to determine whether NIO-imaging can assess tissue adequacy in real time during surveillance bronchoscopies.

The purpose of this study is to collect lung tissue and blood samples from participants who undergo medically-indicated lung surgery and maintain a bank of specimens from a wide range of participants with varying types of lung disease and progressions.   

The purpose of this study is to determine the safety of the SARS-CoV-2 vaccination in patients listed for solid organ transplantation, including heart, lung, liver, kidney, and pancreas.

The purpose of this study is to analyze L-CsA for the treatment of bronchiolitis obliterans syndrome in adults diagnosed with Bronchiolitis Obliterans Syndrome (BOS) following single-lung transplant. Patients will receive either L-CsA (5 mg) via the PARI Investigational eFlow® Device twice daily plus Standard of Care (SoC) treatment, or SoC alone, for a period of 48 weeks. All patients will be eligible to continue in an open-label extension trial of L-CsA following completion of BOSTON-1.

The purpose of this study is to determine whether off-pump bilateral orthotopic lung transplantation (BOLT) or venoarterial extracorporeal membrane oxygenation (VA ECMO) lung transplantation results in higher PGD grade 3 at 48-72 hours, mortality at 90 days, and the combination of these two endpoints.

Secondly, to determine whether off-pump or VA ECMO lung transplantation has more red blood cell transfusion (intraoperative plus the first 24 hours in the ICU), chest tube output the first 24 hours, incidence of re-exploration for bleeding, air emboli, stroke, PGD grade 3 at T0 and T24, pneumonia, need for dialysis, rejection, bronchial dehiscence, tracheostomy, length of ...

The purpose of this study is to evaluate L-CsA for the treatment of bronchiolitis obliterans syndrome in adults diagnosed with Bronchiolitis Obliterans Syndrome (BOS) following double-lung transplant. Patients will receive either L-CsA (5 mg) via the PARI Investigational eFlow® Device twice daily plus Standard of Care (SoC) treatment, or SoC alone, for a period of 48 weeks. All patients will be eligible to continue in an open-label extension trial of L-CsA following completion of BOSTON-2.

The purpose of this study is to to determine if Cardiopulmonary Bypass (CPB) is an independent risk factor for development of Primary Graft Dysfunction (PGD) as compared to Extracorporeal Membrane Oxygenation (ECMO) even when adjusted for all other recipient, donor, biologic and operative risk factors.

The primary research goal of this qualitative study is to explore how patients experience the time between transplant listing and transplantation especially with regards to uncertainty.

The purpose of this study is to examine the effectiveness of a phone call ≤ 30 minute per session, 12-session, weekly individual health-coaching intervention, completed over 12-16 weeks in adults on the lung transplant waiting list versus usual transplant care.

To assess the safety and feasibility of mesenchymal stem cells therapy in patients with transplant related bronchiolitis obliteran syndrome (BOS).

The purpose of this study is to examine the effects of a health coaching intervention on the stress and burden of caregivers of patients awaiting heart or lung transplant.

Hypotheses:  Caregivers will have traits and behaviors pre-transplant that will predict caregiver readiness, quality of life, and transplant recipient outcomes. Specifically, thoracic pre-transplant caregivers report stress, symptoms of anxiety or depression, and perceive high caregiver burden. These factors may be amenable to pre-transplant intervention to improve overall patient and caregiver outcomes.

Aims, purpose, or objectives:  We will conduct a pilot trial to test whether caregivers of heart and lung transplant candidates ...