Current Research Studies

• Heart EXPAND Continued Access Protocol

  Study title: Heart EXPAND Continued Access Protocol

  • Principal investigator: Bryan Whitson, MD, PhD
  • Overview: Continued Access Protocol to collect additional evidence to evaluate the Safety and Effictiveness of the Portable Organ Care System Heart for Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation

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• Organ Care System (OCS) for Hearts from DCD

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

  • Principal investigator: Bryan Whitson, MD, PhD
  • Overview: Clinical Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts from Donors after Circulatory Death (DCD)

• (BOSTON-1) Liposomal Cyclosporine A for BOS

  Study title: Liposomal Cyclosporine A Inhalation Solution in the Treatment of Bronchiolitis Obliterans Syndrome in Patients Post Single Lung Transplant (BOSTON-1)

  • 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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• (BOSTON-2) Liposomal Cyclosporine A for BOS

  Study title: Liposomal Cyclosporine A Inhalation Solution in the Treatment of Bronchiolitis Obliterans Syndrome in Patients Post Double Lung Transplant (BOSTON-2)

  • 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.

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• Cardiopulmonary Exercise Testing

  Study title: Cardiopulmonary Exercise Testing in the Evaluation of Lung Transplant

  • 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.

• Donor Quality Study

  Study title: Donor Quality Study: American College of Chest Physicians Lung Transplant Research Consortium

  • 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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• Ex Vivo Lung Perfusion (EVLP)

  Study title: Novel Lung Trial: Normothermic Ex Vivo Lung Perfusion (EVLP) as an Assessment of Extended/Marginal Donor Lung for Transplant

  • Principal investigator: Bryan Whitson, MD, PhD
  • Overview: This multicenter study is evaluating the safety and efficacy of ex vivo lung perfusion (EVLP) using the XVIVO Perfusion System (XPS™). Human donor lungs that do not meet the standard clinical criteria for donor lung utilization but fit into the study inclusion criteria will be re-assessed by the transplant team. The lungs will then be physiologically assessed during ex vivo perfusion using Steen solution with the addition of methylprednisolone, heparin and antibiotics. EVLP can increase the number of lungs available for transplantation and assure good organ quality for transplantation

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• Extracorporeal Photopheresis for Medicare Recipients

  Study title: Extrcorporeal Photopheresis for Medicare Recipients of Lung Allografts (ECP)

  • 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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• Novel Markers of Human Lung Disease

  Study title: Identification of Novel Markers of Human Lung Disease

  • 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

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• AlloSure: KOAR

  Study title: Evaluation of Patient Outcomes from the Kidney Allograft Outcomes AlloSure Registry (KOAR)

  • 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.

• APOL1: Kidney

  Study title: APOL1 Kidney Transplant Outcomes

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

• BK Viremia in Kidney Recipients

  Study title: MAU868 for Treatment of BK Viremia in Kidney Recipients

  • 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

• Cellular Immunotherapy in Recipients of HLA-matched, Living Donor Kidney Transplants

  Study title: A Phase 3, Randomized, Multi-center, Open-label, Controlled Trial to Assess the Efficacy and Safety of Cellular Immunotherapy With MDR-101 for Induction of Immune Tolerance in Recipients of HLA-matched, Living Donor Kidney Transplants

  • 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.

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• FCR001 Cell Therapy

  Study title: FCR001 Cell Therapy After Kidney Transplant

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

• Fecal Microbiota Transplantation

  Study title: Fecal Microbiota Transplantation for C. Difficile

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

• Immunocompromised Infections Study Protocol

  Study title: Immunocompromised Infections Study Protocol

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

• Letermovir vs. Valganciclovir for Prevention of CMV in Kidney Transplant Recipients

  Study title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of MK-8228 (Letermovir) Versus Valganciclovir for the Prevention of Human Cytomegalovirus (CMV) Disease in Adult Kidney Transplant Recipients

  • 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.

• Long Term Outcomes of Living Donation or ALTOLD

  Study title: Assessing Longterm Outcomes of Living Donation or ALTOLD 

  • 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

• BB3 to Reduce Delayed Graft Function

  Study title: A Multicenter, Prospective, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study of BB3 to Reduce the Severity of Delayed Graft Function in Recipients of a Deceased Donor Kidney 

  • 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.

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• QPI-1002 for Prevention of Delayed Graft Function

  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.

  • 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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• Cinryze® for the Treatment of Acute Antibody-Mediated Rejection

  Study title: A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cinryze® (C1 Esterase Inhibitor [Human]) for the Treatment of Acute Antibody-Mediated Rejection in Kidney Transplant Patients

  • 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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• Sirolimus and Everolimus in Combination with Low Dose Cyclosporine

  Study title: Differentiating Sirolimus and Everolimus in Combination with Low Dose Cyclosporine in De Novo Kidney Transplant Patients—The Effects on Vascular Endothelial and Kidney Function

  • Principal investigator: Amer Rajab, MD, PhD
  • Overview: This is an optional sub-study for patients enrolled in the Zortress vs. Rapamune research study with Dr. Pelletier. For this sub-study we are working with a researcher at the University of Colorado, Uwe Christians, MD, to extend the Zortress vs Rapamune study into the laboratory. By extending the study into the laboratory we will be able to test plasma from transplant patients for specific molecular markers related to kidney and vascular function. This testing will allow us to see how different medications affect these molecular markers and thus how different medications affect kidney and vascular function

• Comparing Everolimus and Sirolimus in Renal Transplant Recipients

  Study title: A Prospective, Randomized, Single Center Pilot Study Comparing Patient and Graft Survival, Adverse Events and Tolerability of Zortress® (Everolimus) Versus Rapamune® (Sirolimus) in Combination With Low Dose Neoral® (Cyclosporine) Dosed by C2 Monitoring, in Deceased and Living Donor Renal Transplant Recipients Under a Thymoglobulin® (Antithymocyte Globulin) and Rapid Steroid Induction Protocol.
  

  • 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

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• Acute Liver Failure

  Study title: A Multi-Center Group to Study Acute Liver Failure
  

  • Principal investigator: James Hanje, MD
  • Overview: The objective of this study is to further elucidate the pathogenesis of liver injury and multi-organ failure and collect clinical and demographic data on patients with acute liver failure

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• 13C-Methacetin Breath Test

  Study title: 13C-Methacetin Breath Test for the Prediction of Outcome in Acute Liver Failure  (ALF-MBT) 

  • Principal investigator: James Hanje, MD
  • Overview: The primary objective of the study is to assess the safety and effectiveness of the 13C-Methacetin Breath Test for the prediction of outcome in acute liver failure

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• Hemostatic Abnormalities

  Study title: Potential Use of Rotational Thromboelastometry to Explore Hemostatic Abnormalities in Patients with Acute Liver Failure (ALF-ROTEM) 

  • Principal investigator: James Hanje, MD
  • Overview: Observations suggest that patients with ALF maintain normal global hemostasis under most conditions, and offer mechanisms whereby the “bleeding tendency” may actually be a tendency to clot. These studies have the potential to show that administering pro-hemostatic factors does not decrease post-procedural bleeding complications, but may adversely affect outcome, contrary to common belief

• Portable Organ Care (OCS™) System for DCD Liver Donors

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

  • Principal investigator: Sylvester Black, MD, PhD
  • Overview: Prospective Trial to Evaluate the Effectiveness of The Portable Organ Care System (OCS™) Liver for Preserving, Optimizing and Assessing Currently Seldom Utilized DCD Donor Livers for Transplantation
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• OCS® Liver PROTECT Trial

  Study title: Continued OCS™ Liver PROTECT Trial
  

  • Principal investigator: Sylvester Black, MD, PhD
  • Overview: Continued Access Protocol to Evaluate the Effectiveness of the Portable Organ Care System (OCS™) Liver for Preserving and Assessing Donor Livers for Transplantation

• Quantitation of HCV RNA

  Study title: Quantitation of HCV RNA in Whole Blood Samples Obtained from Individual Subjects at Specific Time-Points During the Course of Treatment for Hepatitis C
  

  • Principal investigator: James Hanje, MD
  • Overview: The purpose of this protocol is to assess the overall performance of a new nucleic acid test to monitor the viral load of hepatitis C patients receiving or initiating a drug treatment regimen by obtaining whole blood samples at specific time points over the course of their therapy

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• Islet Allotransplantation in Type 1 Diabetes

  Study title: Islet Allotransplantation in Type 1 Diabetes

  • 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.

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• Collaborative Islet Transplant Registry

  Study title: Collaborative Islet Transplant Registry

  • 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.

• Advancing Treatment for Pancreatitis

  Study title: Advancing Treatment for Pancreatitis: A Prospective Observational Study of TPIAT (POST Study)

  • 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