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• Principal investigator: Brian Keller, MD, PhD
• Overview: BOSTON-1 is a Phase III randomized, controlled clinical trial of lysosomal cyclosporine A (L-CsA) for the treatment of bronchiolitis obliterans syndrome (BOS), a form of chronic rejection, in adults 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.

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• Principal investigator: Brian Keller, MD, PhD
• Overview: BOSTON-2 is a Phase III randomized, controlled clinical trial of lysosomal cyclosporine A (L-CsA) for the treatment of bronchiolitis obliterans syndrome (BOS), a form of chronic rejection, in adults following double lung transplant. Patients will receive either L-CsA (10 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.

• Principal investigator: David Nunley, MD
• Overview: This investigation is designed to determine which physiologic parameters denoting physical fitness may be associated with improved outcomes following lung transplantation.  Additionally, the study is designed to determine which of these parameters may further be improved via pre-transplant rehabilitation. All study participants have two non-invasive cardiopulmonary exercise tests performed which are separated by an interval of Pulmonary Rehabilitation. All candidates for lung transplantation are potentially eligible for enrollment.

• Principal investigator: David Nunley, MD
• Overview: This investigation is conducted as part of a consortium that consists of 13 lung transplant centers throughout the United States, and is designed to identify factors that help transplant physicians in their decision to accept or decline donor lungs for transplantation. Phase 2 of this investigation will involve using predictive models to better standardize donor lung acceptance for transplantation.

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• Principal investigator: Brian Keller, MD, PhD
• Overview: This is a multi-institutional clinical trial to determine the efficacy and tolerability of Extracorporeal Photopheresis (ECP) for the treatment of either refractory or newly diagnosed Bronchiolitis Obliterans Syndrome (BOS), a form of chronic rejection, in patients after lung transplantation. In compliance with the Centers for Medicare and Medicaid Services' (CMS) Coverage with Evidence Development (CED) decision, the study will collect specified demographic, comorbidity, treatment, and outcome data exclusively for Medicare beneficiaries who are treated with Extracorporeal Photopheresis for either refractory or New Bronchiolitis Obliterans Syndrome.

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• Principal investigator: Megan Ballinger, PhD
• Overview: This study examines the role of specific cell types in regulating lung diseases such as interstitial lung disease, chronic obstructive pulmonary disease and pulmonary hypertension. Cells are isolated from a diseased lung post-transplantation and measured for a variety of parameters including production of cellular mediators, expression of genes important in signal transduction pathways, functionality of cells, viability and proliferation. Data collection from these cells will provide essential information regarding cellular dysfunction and dysregulation during lung disease and will enable the development of novel therapeutics

• Principal investigator: Reem Daloul, MD
• Overview: This observational registry evaluates patient outcomes in kidney transplant recipients who undergo regular use of AlloSure testing.  The registry will provide information on outcomes of patients who undergo monitoring for rejection using AlloSure in clinical practice compared to outcomes in patients who are not monitored for rejection using AlloSure.

• Principal investigator: Todd Pesavento, MD 
• Overview: APOL1 Long-term Kidney Transplant Outcomes Network

• Principal investigator: Amer Rajab, MD, PhD
• Overview: A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Pharmacokinetics and Efficacy of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients

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• Principal investigator: Amer Rajab, MD, PhD
• Overview: The purpose of this study is to demonstrate the safety and efficacy of cellular immunotherapy with MDR-101 for induction of functional immune tolerance in recipients of human leukocyte antigen-matched, living donor kidney transplants.

• Principal investigator: Todd Pesavento, MD 
• Overview: Evaluation of safety, efficacy and immunosuppression therapy following FCR001 cell therapy after kidney transplant vs standard of care

• Principal investigator: Todd Pesavento, MD 
• Overview: Fecal Microbiota Transplantation For C. Difficile Infection in Solid Organ Transplant Recipients

• Principal investigator: Reem Daloul, MD
• Overview: Research in Transplant and Immunocompromised Infections Study Protocol

• Principal investigator: Alejandro Diez, MD
• Overview: The purpose of this study is to evaluate the efficacy of letermovir versus valganciclovir, as measured by the proportion of participants with adjudicated CMV disease through post-transplant week 52.

• Principal investigator: Todd Pesavento, MD 
• Overview: The purpose of this study is to thoroughly evaluate the long-term risk, if any, of kidney donation. Specific aims are glomerular filtration rate, risk factors for cardiovascular disease and proteinuria in healthy controls compared to subjects post-unilateral nephrectomy. This is a longitudinal study follow-up is occurring at eight sites and has been approved for nine years of follow-up

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• Principal investigator: Ashraf El-Hinnawi, MD 
• Overview: The purpose of this research study is to see if an investigational drug, BB3, is safe and effective for increasing the amount of urine kidneys produce post-transplant.

Study title: A Phase three, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of QPI-1002 for Prevention of Delayed Graft Function in Recipients of a Donation After Brain Death Older Donor Kidney Transplant 

Note: This study has finished enrollment and Ohio State was one of the top 10 enrolling sites globally and the third highest enrolling site in the nation.

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• Principal investigator: Ashraf El-Hinnawi, MD 
• Overview: Ohio State is one of the top ten enrolling centers in the U.S. for this phase three randomized, placebo-controlled, double-blind, multi-center trial stratified by donor age and by region to evaluate the reduction in incidence and severity of delayed graft function with kidney allografts from DBD donors who were at least 45 years of age

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• Principal investigator: Amer Rajab, MD, PhD
• Overview: This is a multicenter, multinational study evaluating the efficacy of 20,000 total units of Cinryze given intravenously in seven doses over 13 days as an adjunct to plasmapheresis and intravenous immunoglobulin (IVIg) for the treatment of acute antibody-mediated rejection in kidney transplant recipients as measured by the proportion of subjects with new or worsening transplant glomerulopahty (TG) within six months

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• Principal investigator: Amer Rajab, MD, PhD
• Overview: The primary objective of this pilot study will be to determine equivalency of Zortress® as compared to Rapamune® when used in our de novo immunosuppression regimen following renal transplantation. The primary endpoint will be a composite endpoint of graft survival (non-death censored) and biopsy proven acute rejection at one year. The primary outcome of immunosuppressive protection would be studied in our Thymoglobulin and rapid steroid discontinuation protocol, with "half-dose" Neoral as described above

Study title: Portable Organ Care System (OCS™) for DCD Liver Donors

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• Principal investigator: Amer Rajab, MD, PhD
• Overview: This is a single center, prospective, phase one study investigating the use of islet transplantation for the treatment of type 1 diabetes in subjects receiving islets alone or islets after kidney transplant. The aims of this study are to determine the safety of islet transplantation, to determine whether islet transplantation will reduce the frequency of severe hypoglycemia events, to determine whether a steroid-free immunosuppressive protocol will prevent rejection in islet transplants and to achieve insulin independence after islet transplant. A total of 20 subjects will be transplanted with a 12-month follow-up after the last transplantation.

• Principal investigator: Amer Rajab, MD, PhD
• Overview: A multi-center study designed to collect and analyze data on both allogeneic and autologous islet transplant patients and outcomes allowing for a comprehensive analysis that will identify risk factors and determinants for success to help move the field forward.

• Principal investigators:  Luis F. Lara, MD and Melena Bellin, MD, University of Minnesota
• Overview: A prospective data gathering trial of patients undergoing total pancreatectomy and auto islet transplantation