Penn Lung Transplant performs research studies to enhance treatment options. Take a look at our current clinical trials.

Lung Transplant Clinical Trials

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: Djamila Mallem, CCR

Email: djamila.mallem@uphs.upenn.edu

NOVEL Lung Trial Extension: Normothermic Ex Vivo Lung Perfusion (EVLP) as an Assessment of Extended/Marginal Donor Lungs

Investigator: Edward Cantu III, MD

There is an ongoing shortage of suitable donor lungs for transplant, and because of this there is still significant wait-list mortality. A large number of donor lungs are not used for transplant because they do not meet standard transplant criteria. The purpose of this study is to see if donor lungs that may not normally qualify for transplant can be further assessed and/or improved so they can be transplanted.

Research coordinator: Djamila Mallem, CCR

Email: djamila.mallem@uphs.upenn.edu

PXUS 14-001: A Phase 2, Multi-Center, Open-Label Study to Measure the Safety of Extending Preservation and Assessment Time of Donor Lungs Using Normothermic Ex Vivo Lung Perfusion and Ventilation (EVLP) as Administered by the Sponsor Using the Toronto EVLP System

Investigator: Edward Cantu III, MD

There is an ongoing shortage of suitable donor lungs for transplant, and because of this there is still significant wait-list mortality. A large number of donor lungs are not used for transplant because they do not meet standard transplant criteria. The purpose of this study is to see if donor lungs that may not normally qualify for transplant can be further assessed and/or improved so they can be transplanted.

Coordinator: Djamila Mallem, CCR

Email: djamila.mallem@uphs.upenn.edu

Long Pentraxin-3 Genomics and Outcomes after Lung Transplantation

Investigator: Joshua Diamond, MD

Primary graft dysfunction (PGD) is the main cause of early morbidity and mortality after lung transplantation. PGD affects 10 to 30 percent of all lung transplant recipients and leads to prolonged mechanical ventilation and ICU length of stay, poor functional outcomes, and increased risk of chronic rejection (bronchiolitis obliterans syndrome (BOS)), the major limiting factor to long term survival after lung transplantation. Genetic and plasma protein differences in a central innate immune mediator, long pentraxin-3 (PTX3), are strongly associated with PGD but the functional implications of this genetic variation, and how it leads to PGD, are unknown. This study will provide insight into whether genetic variation in PTX3 results in altered gene expression, increased PTX3 production and release, and activation of complement, leading to non-cardiogenic pulmonary edema and PGD, evaluate the association of PTX3 with BOS, and may highlight a novel target for potential therapeutic intervention.

Email: joshua.diamond@uphs.upenn.edu

Risk Factors for Primary Graft Dysfunction

Investigator: Jason Christie, MD, MSCE

The overall aim of the project is to learn more about potential complications of lung transplantation. We are investigating the way the body responds to lung transplantation by measuring natural substances in the blood. We are aiming to determine the association of clinical and biological risk factors in recipients and donors with the development of primary graft dysfunction (PGD) following lung transplant. We also aim to quantify the relationship of donor smoke exposure with greater PGD risk to better match donors to recipients, and to create new knowledge of the mechanisms by which smoking contributes to PGD.

Research coordinator: Michelle Oyster, MS, CCRC

Tel: 215-573-4767

Email: Michelle.Oyster@uphs.upenn.edu

Regulatory T Cells and Primary Graft Dysfunction

Investigator: Jason Christie, MD, MSCE

The purpose of this research study is to test the function of regulatory T cells, which are a component of the immune system that suppresses immune responses of other cells, and determine their effects on early outcomes after lung transplant. It is believed that impaired function of regulatory T cells plays a role in the development of complications after lung transplantation. Our studies may identify new diagnostic or therapeutic options leading to better outcomes after transplant.

Research coordinator: Michelle Oyster, MS, CCRC

Tel: 215-573-4767

Email: Michelle.Oyster@uphs.upenn.edu

Longitudinal Outcomes After Lung Transplantation

Investigator: Joshua Diamond, MD, MSCE

This research study is designed to learn more about potential long term complications of lung transplantation. We are looking at whether variations in genes (traits or instructions, that are inherited from parents and passed on from generation to generation) and/or expression of genes can be detected in the blood or from brushings of the airways and whether these variations are associated with rejection after lung transplantation. Changes in these substances over time may help us identify potential complications after lung transplantation, including chronic rejection.

Research coordinator: Melanie Brown, BS

Tel: 215-573-8906

Email: Melanie.Brown2@uphs.upenn.edu

Lung Transplant Microbiome and Chronic Allograft Dysfunction

Investigator: Jason Christie, MD, MSCE; Ronald Collman, MD; Joshua Diamond, MD, MSCE

Long term survival after lung transplantation is limited mainly by a syndrome of late transplant failure called Bronchiolitis Obliterans Syndrome (BOS). Research suggests that microbes (bacteria, fungi, viruses) play an important role in the development of BOS. The purpose of this study is to learn more about what organisms live in the blood, respiratory and gastrointestinal tracts of lung transplant recipients and the role these organisms play in the occurrence of BOS and late transplant failure.

Research coordinator: Melanie Brown, BS

Tel: 215-573-8906

Email: Melanie.Brown2@uphs.upenn.edu

Obesity, Inflammation and Lung Injury After Lung Transplantation

Investigator: Jason Christie, MD, MSCE

One out of five adults who undergo lung transplantation dies within the first year of transplantation, most commonly as a consequence of damage to the new lungs early after transplantation. Overweight and obese adults undergoing lung transplantation are twice as likely as others to suffer from this early damage. The primary purpose of this study is to find out if the amount and type of muscle and fat in the body can help us understand why some people have complications after lung transplantation. We will determine if inflammation in fat tissue is responsible for this early damage so that we can develop treatments aimed at decreasing fat inflammation and thereby avoid damage to the transplanted lungs.

Research coordinator: Melanie Rushefski, BS

Email: Melanie.Rushefski@uphs.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

Targeted Nanomedicine for ALI and I/R

Investigator: Edward Cantu III, MD

The goal is to develop effective treatment for vascular inflammation and oxidative stress the represent a common pathological mechanism in many disease conditions including ischemia, stroke, sepsis and acute lung injury. The pulmonary vascular endothelium is a key target for therapeutic interventions in the latter setting.

Email: Edward.CantuIII@uphs.upenn.edu

A Phase 2B Randomized, Controlled Trial Evaluating GS-5806 in Lung Transplant Recipients with Respiratory Syncytial Virus (RSV)

Investigator: Vivek N. Ahya, MD

Sponsor: Gilead Sciences

RSV has been associated with life threatening pneumonias and is thought to be a risk factor for developing accelerated chronic lung allograft dysfunction. At present, there are no approved therapies for this potentially dangerous infection in adult lung transplant recipients. The purpose of this clinical trial is to evaluate a new medication that attempts to treat RSV infection in lung transplant recipients who have respiratory infection symptoms for less than 7 days.

Research coordinator: Victoria Fleck

Email: fleckv@uphs.upenn.edu

Lymphangioleiomyomatosis (LAM) Clinical Trial

The Safety of Simvastatin in Patients with Pulmonary Lymphangioleiomyomatosis and with Tuberous Sclerosis Complex (The SOS Trial)

Investigator: Vera P. Krymskaya, Ph.D., M.B.A.

Sponsor: Airways Biology Initiative, University of Pennsylvania

The purpose of this research study is to see if simvastatin can be taken safely in patients with either LAM or TSC, who are already being treated with everolimus or sirolimus.   This is the first step in looking at simvastatin as a drug that may help patients, by impacting the growth and survival of cells that make up the lung lesions that cause problems in LAM and TSC patients.

Research coordinator: Leslie Staines

Email: Leslie.staines@uphs.upenn.edu

Nontuberculous Mycobacteria (NTM) Clinical Trial

CONVERT Study: A Randomized, Open-Label, Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients with Nontuberculous Mycobacterial (NTM) Lung Infections Caused by Mycobacterium avium complex (MAC) that Are Refractory to Treatment

Investigator: Daniel Dorgan, MD

Sponsor: Insmed Incoporated

The CONVERT study is a clinical research study designed to explore an investigational medication—Liposomal Amikacin for Inhalation (LAI)—in adult patients with Nontuberculous Mycobacterial (NTM) lung infections caused by Mycobacterium avium Complex (MAC), who have not improved with previous treatments.

Research coordinator: Victoria Fleck

Email: fleckv@uphs.upenn.edu

Cystic Fibrosis (CF) Clinical Trial

Informed Choices

Investigator: Denis Hadjiliadis, MD

Sponsor: Cystic Fibrosis Foundation

The purpose of the study is to design a decision aid, which is a tool to help doctors and patients think about making decisions, for end-of-life care for people with cystic fibrosis (CF). The purpose of this particular phase of the study is identify CF patient and surrogate caregiver attitudes about advance care planning and factors that are perceived as most important for decision making through the use of focus groups.

Research coordinator: Victoria Fleck

Email: fleckv@uphs.upenn.edu

Pulmonary Hypertension (PH) Clinical Trials

A Randomized, Double-Blind, Placebo-Controlled, Prospective, Multi-Center, Parallel Group Study to Assess the Safety and Efficacy of Macitentan in Patients with Portopulmonary Hypertension (PORTICO)

Investigator: Kerri Akaya Smith, MD

Sponsor: Actelion Pharmaceuticals Ltd

The purpose of this study is to evaluate the effect of macitentan on pulmonary vascular resistance (PVR) as compared to placebo in patients with portopulmonary hypertension (PoPH).

Research coordinators: Diane Pinder, BS and Mamta Patel, RN

Emails: pinder@mail.med.upenn.edu; mamta.patel@uphs.upenn.edu

Sorafenib in Patients with Hepatopulmonary Syndrome: A Double-Blind, Randomized Clinical Trial

The purpose of this study is to determine whether sorafenib affects alveolar-arterial oxygen gradient (AaPO2) at 12 weeks in patients with HPS. The study will also examine effects of sorafenib on biomarkers of angiogenesis, including circulating hematopoietic progenitor cells and plasma levels of VEGF, as well as its impact on 6-min walk distance and health-related QOL. Ultimately, the feasibility and safety of sorafenib as a novel therapeutic for the treatment of HPS will be determined.

Research coordinators: Marita Lynch and Tiffany Sharkoski, BA

Emails: marita.lynch@uphs.upenn.edu; sharkosk@exchange.upenn.edu

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