Along with providing quality care to our patients, the expert team at the Penn Transplant Institute conducts clinical trials and research to develop new treatments and improve the lives of our patients before, during and after lung transplantation.

Penn Medicine frequently adds and updates clinical trials. Patients may search for ongoing trials and volunteer to participate in studies to develop new diagnostic and clinical treatments and improve current standards of care.

Lung Transplant Clinical Trials at Penn

A Study to test how effective Belumosudil Tablets are for treating adult participants with chronic lung allograft dysfunction (ROCKaspire)

Investigator: Joshua Diamond, MD

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 and who have evidence of progressive CLAD despite azithromycin therapy.

Research coordinator: Sarah Alam
Email: Sarah.Alam@pennmedicine.upenn.edu

Belumosudil to block CLAD in high risk lung transplant recipients: a randomized, multicenter, double blind, placebo-controlled trial

Investigator: Joshua Diamond, MD

This double-blind, randomized, placebo-controlled, multicenter study will investigate if taking the study drug, Belumosudil, for 52 weeks in addition to usual clinical care and medication, will prevent Chronic Lung Allograft Dysfunction (CLAD) in participants who have a lung biopsy that shows evidence of rejection or inflammation to the transplanted lung(s). Belumosudil is an investigational drug that blocks a molecule in the body that reduces inflammation and scarring and may play a role in the development and progression of CLAD.

Research Manager: Michelle Oyster
Email: Oysterm@pennmedicine.upenn.edu

Cystic Fibrosis Lung Transplant Consortium Biorepository and Registry

Investigator: Jason Christie, MD

The purpose of the CFLTC Biorepository and Registry is to collect human tissue (such as blood and bronchoalveolar lavage [BAL]) and clinical information to be used for future research studies related to lung transplantation to understand pathogenesis of CLAD and other complications of lung transplantation. The goal is to recruit patients who will receive or have received a double lung transplant. Both non-cystic fibrosis and cystic fibrosis patients will be recruited.

Research Manager: Michelle Oyster
Email: Oysterm@pennmedicine.upenn.edu

Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes (The PROMISE Lung Study)

Investigator: Jason Christie, MD

The purpose of the PROMISE Lung Study is to find out how to improve the results of lung transplant. To do this, we will collect data, blood samples, and patient reported outcomes from lung transplant candidates and recipients and the recipient’s lung donor across participating Lung Transplant Consortium centers. With the data, we hope to learn what causes poor lung function. Additionally, we would like to understand how these issues affect quality of life and survival.

Research Coordinator: Jessica Johnson
Email: Jessica.Johnson@pennmedicine.upenn.edu

The Impact of Body Composition on Peri-Operative and Patient-Centered Outcomes in Lung Transplantation

Investigators: Jason Christie, MD, Joshua Diamond, MD

The purpose of this study is to understand how body composition may influence the overall success of lung transplantation. The goal of this study is to better understand why some people benefit more from lung transplantation than others. Adults who are lung transplant candidates between the ages of 18 and 75 will be enrolled at 3 Lung Transplant Consortium centers. Bioelectrical impedance measures, surveys, and clinical data will be collected.

Research Coordinator: Jessica Johnson
Email: Jessica.Johnson@pennmedicine.upenn.edu

Prospective Registry of Outcomes in Patients Electing Lung Transplantation (PROPEL): A Correlative Analysis Using Gene Signature Array

Investigator: Edward Cantu III, MD

Primary graft dysfunction (PGD) is a form of severe acute lung injury occurring within the first 72 hours after lung transplantation, and is the primary cause of death in the first year. It occurs in approximately one in three patients, and the cause remains unknown. Utilizing genetic analysis, the purpose of this research study is to understand what causes PGD, and to be able to predict and prevent it in the future. Additionally, we are trying to understand what causes the lung disease, so that we can learn how we may develop therapeutics to prolong or prevent someone from needing a lung transplant.

Research Coordinator: Allie Raevsky and Aya Saleh
Email: Allie.Raevsky@pennmedicine.upenn.edu and Aya.Saleh@pennmedicine.upenn.edu

PROPEL Multicenter Cohort Study

Investigator: Edward Cantu III, MD

The purpose of this research project is to develop a test that we can use to predict a common complication that occurs shortly after lung transplant called primary graft dysfunction (PGD). The test will use transcripts (instructions for making proteins obtained from the donor tissue) to develop a picture of organ quality based on the presence of inflammation. Predicting PGD before using donor organs may help reduce deaths and improve outcomes of patients receiving a lung transplant in the future. This research project will collect samples and information from the lung donors as well as clinical information on lung transplant recipients.

Research Coordinator: Allie Raevsky and Aya Saleh
Email: Allie.Raevsky@pennmedicine.upenn.edu and Aya.Saleh@pennmedicine.upenn.edu

University of Pennsylvania Lung Transplant Biorepository

Investigator: Edward Cantu III, MD

The purpose of this research project is to collect and store samples and protected health information about people who may have or have had a lung transplant. This research project will also collect samples and information from the lung donors. A collection of medical information (data) and samples is called a biorepository. The samples and medical information will be used for various reasons by researchers for future studies. The research may involve different types of genetic testing. Genetic testing may look at DNA, RNA and proteins. Through such studies, researchers hope to find ways to improve outcomes after lung transplant and learn more about health and diseases.

Research Coordinator: Allie Raevsky and Aya Saleh
Email: Allie.Raevsky@pennmedicine.upenn.edu and Aya.Saleh@pennmedicine.upenn.edu

ALAMO: AlloSure Lung Assessment and Metagenomics Outcomes Study

Investigator: Edward Cantu III, MD

The research study is being conducted to help clinicians monitor lung transplant patients to examine the risk for allograft rejection and/or infection. The registry will collect medical information and history related to patient lung transplant care (medications, diagnoses, and other information in your medical record), storing that information in a database, and using that information to answer specific research questions now and in the future.

Research Coordinator: Allie Raevsky and Aya Saleh
Email: Allie.Raevsky@pennmedicine.upenn.edu and Aya.Saleh@pennmedicine.upenn.edu

PC_ASP_006: A double-blind, randomized, placebo-controlled study to assess the safety and efficacy of nebulized PC945 when added to systematic antifungal therapy for the treatment of refractory invasive pulmonary aspergillosis

Investigator: Edward Cantu III, MD

The low systemic bioavailability and high degree of lung penetration and retention of nebulized PC945 could make it a suitable antifungal agent to be used in combination with systemic antifungal therapy for the treatment of invasive pulmonary aspergillosis (IPA) in order to improve treatment success rates without increasing the safety risk. The main objective of this study is therefore to assess the efficacy, safety and tolerability of PC945 when administered in combination with systemic antifungal therapy for the treatment of refractory IPA.

Research Coordinator: Allie Raevsky and Aya Saleh
Email: Allie.Raevsky@pennmedicine.upenn.edu and Aya.Saleh@pennmedicine.upenn.edu

Lung Transplant Clinical Center to Improve Surgical Outcomes (LTCC-ISO)

Investigator: Edward Cantu III, MD

The purpose of this study is to develop a machine learning (software that evaluates patterns to make predictions from data) approach using transplant patient clinical data and biological specimens (blood and lung tissue) in order to predict optimal outcomes after transplant surgery. Duke University is working with the University of Pennsylvania, University of Minnesota, and University of Louisville for this research study. Duke University will serve as the data coordinating center for the study.

Research Coordinator: Allie Raevsky and Aya Saleh
Email: Allie.Raevsky@pennmedicine.upenn.edu and Aya.Saleh@pennmedicine.upenn.edu

Lung Transplant Donor: Prediction, Evaluation and Mechanism

Investigator: Edward Cantu III, MD

The central hypotheses are that lung injury occurring in the donor lung prior to reperfusion can be evaluated by gene expression methods to determine PGD risk, identify "low risk" organs that would have been discarded that can be transplanted, and understand common mechanisms of PGD and recovery on EVLP

Email: Edward.CantuIII@uphs.upenn.edu

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