Clinical Trials

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 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.

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. 

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.

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 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 purpose of this study is to evaluate the safety and tolerability of PC945 for the prevention of fungal aspergillus infections in the lung in patients who have received a lung transplant.

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.

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.

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 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 assess the long-term effectiveness and safety of L-CsA plus Standard of Care (SoC) in the treatment of BOS in single (SLT) and double lung transplant (DLT) recipients.

Enrollment will be limited to patients who have completed 48 weeks participation in either the BT-L-CsA-301-SLT (BOSTON-1) or BT-L-CsA-302-DLT (BOSTON-2) trial. All patients in this clinical trial will receive L-CsA in addition to Standard of Care, regardless of randomization arm in prior trials.

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 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 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 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 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 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 evaluate the clinical performance of the Aptima CMV Quant assay on the Panther system in ethylenediaminetetraacetic acid (EDTA) plasma samples from solid organ transplantation recipients (SOTR) and hematopoietic stem cell transplant recipients (HSCTR).

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 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 ...

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 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.