Division of Transplantation Surgery Research Team

The research we perform in the Ohio State Division of Transplant Surgery covers basic, translational and clinical, with the goal of developing the next generation of surgical innovation. What we learn at the bench we apply to the bedside.

Current Research Studies:

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
  • Website: https://clinicaltrials.gov/ct2/show/NCT01365429?term=evlp+lung&rank=4
  • 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. 

Study Title: Assessing Long Term 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. 

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: Ronald Pelletier, MD
  • Website: https://clinicaltrials.gov/show/NCT02547220
  • Overview: This is a multicenter, multinational study evaluating the efficacy of 20,000 total units of Cinryze given intravenously in 7 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 6 months.

Study Title: A Phase 3, 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
  • Principal Investigator: Ashraf El-Hinnawi, MD
  • Website: https://clinicaltrials.gov/show/NCT02610296
  • Overview: This is a Phase 3 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.

Study Title: Prospective, Randomized Trial of Belatacept Switch in Renal Transplant Recipients With Delayed Graft Function
  • Principal Investigator: Jon Von Visger, MD
  • Website: https://clinicaltrials.gov/show/NCT02134288
  • Overview: This study is being conducted to determine if kidney transplant recipients with delayed graft function (DGF) who are switched to the immunosuppressive regimen of belatacept with mycophenolate and steroid will recover from delayed graft function (DGF) in less time (which could potentially lower the risk of rejection associated with delayed graft function) than kidney transplant recipients with delayed graft function (DGF) who remain on the current standard immunosuppressive regimen (standard of care).

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: Ronald Pelletier, MD
  • Website: https://clinicaltrials.gov/show/NCT01976390
  • 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 1 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: Investigation of cytokine gene polymorphisms, T cell immune profiles and alloantibody levels and isotypes from peripheral blood in primary kidney transplant patients
  • Principal Investigator: Ginny Bumgardner, MD
  • Overview: The purpose of this study is to investigate the effect of mTOR inhibition dosing and levels in the presence or absence of calcineurin inhibition on the quantity and isotype of de novo post-transplant alloantibody and to correlate these findings with concurrent CD8:CD4 T cell ratios, CD4+ T cell IL-4:INFg cytokine ratios, cytokine/cytokine receptor gene polymorphisms, race, and gender in primary human kidney transplant recipients. This study has a one year follow-up.

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: Ronald Pelletier, MD
  • 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.

Our Researchers

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