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Surgical Director, VAMC Transplant ProgramAssociate Professor of Surgery
- Transplantation and Hepatobiliary Surgery
Primary Office: GH SE400Iowa City, IA 52242
Primary Office Phone: 319-356-1334
BS, Biology, Fairleigh Dickinson University, Teaneck, NJMD, UMDNJ- Robert Wood Johnson Medical School,Teaneck, New Jersey
Residency, General Surgery, UMDNJ- Robert Wood Johnson Medical School, New Brunswick, New JerseyFellowship, Transplant Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
Iowa Medical LicenseBoard Certified American Board of Surgery National Board of Examiners
Belatacept Evaluation of Nephroprotection and Efficacy as First-Line Immunosuppression Trial (BENEFIT- IM103008) and Belatacept Evaluation of Nephroprotection and Efficacy as First-Line Immunosuppression Trial- Extended Criteria Donors (BENEFIT-EXT IM103027) Bristol-Myers Squibb Belatacept (LEA29Y) represents a new class of immunosuppressive for use in renal transplantation. Belatacept is an immunomodulator that selectively inhibits costimulation of T-cells. The purpose of these two pivotal studies is to evaluate the effects of belatacept compared with cyclosporine on renal function and graft survival in kidney transplant recipients (IM103008) and in ECD kidney transplant recipients (IM103027). The primary objectives will be to evaluate the composite subject and graft survival by 12 months, the composite of measured GFR at month 12 or a decrease in measured GFR from month 3 to 12, and the incidence of acute rejection by month 12. Both studies are three-year phase III, multi center, randomized, partially-blinded, active controlled, parallel group study comparing three regimens: more intensive (MI) belatacept, less intensive (LI) belatacept, or cyclosporine. All will receive background therapy with basiliximab and maintenance with MMF and steroids. Belatacept is administered as a ï¿½ hour infusion every two weeks for the first three months, then monthly until the end of the three year study. Belatacept Conversion Trial in Renal Transplantation (IM103010) Quintiles This trial is in the early start up phase and is currently pending. The trial will study the conversion of patients from a standard immunosuppressive regimen to a Belatacept based regimen. A 24-month, multicenter, randomized open-label non-inferiority study of efficacy and safety comparing concentration-controlled Certican ï¿½ in two doses (1.5 and 3.0 mg/day starting doses) with reduced Neoral ï¿½ versus 1.44 g Myfortic ï¿½ with standard dose Neoral ï¿½ in de novo renal transplant recipients. Novartis Certican (everolimus, RAD001) is rapamycin derivative for renal transplant indications. The purpose of this study is to examine the impact of Certican with reduced Neoral dose on efficacy failure and renal function relative to Myfortic with standard dose of Neoral. The primary objective is to compare the composite efficacy failure rate (treated BPAR, graft loss, death, loss to follow up). Subjects will be randomized 1:1:1 to receive one of the two Certican doses with reduced dose Neoral or Myfortic with standard dose Neoral. Therapeutic drug monitoring will be performed to maintain the protocol required Neoral and Certican trough levels. All groups will receive background therapy with Simulect and steroids according to local practice. A retrospective study of en-block and split pediatric kidney transplant and outcomes at UIHC. Investigator initiated The purpose of this study is to collect and analyze the data from UIHC patient record for pediatric en- block and split pediatric kidney transplant under the donor age of 5 yrs. A retrospective data collection will be done for all the UIHC and affiliated sites for pediatric kidney transplant and analysis will be done for result, outcomes and efficiency of en-block and split pediatric kidney transplant from the donors under the age of 5 years. After analysis and result of these data we are hoping that we can increase procurement of kidneys for donation from the pediatric age group, increase the use of pediatric kidneys for organ transplantation, future clinical studies and ultimately increase renal graft survival rates, particularly those procured from children. There is recent evidence to suggest that en bloc kidneys have better long-term function than split pediatric kidneys. This observation may not be universal, but may be biased by center experience. We would like to extend our investigation to the national data set. Exploring the hypothesis that there is no center effect on pediatric kidney outcome comparing split and en bloc kidneys is relevant to the transplant community because acceptance or rejection of the hypothesis will have ramifications on organ allocation and usage. What is the effect hepatocellular tumor down staging prior to liver transplant? Investigator initiated In patients with cirrhosis, liver transplantation is indicated as a potentially curative therapy for patients with stage I and II hepatocellular carcinoma (HCC). Although initially controversial, multiple reports now demonstrate that five-year post transplant patient survival for cirrhotics with small tumors is similar to survival among patients undergoing transplant without cancer. Therefore, the transplant community as sanctioned by the United Network for Organ Sharing (UNOS) grants MELD (model for end stage liver disease) exception points to patients with small HCC in order to improve their status on the waiting list. However, patients with stage III and IV tumors have been found to have worse long term outcomes due to tumor recurrence. Reflective of the poorer outcomes, UNOS does not grant exception points to patients with tumors exceeding stage II. Most centers are reluctant to transplant patients with higher stage tumors due to poor outcomes, and doing so as a practical matter has become difficult without the benefit of MELD exception points. Several reports now indicate the feasibility of obtaining acceptable post transplant outcomes for some stage III and IV patients who are treated with pretransplant transarterial hepatic chemoembolization (TACE), radiofrequency ablation (RFA), percutaneous ethanol injection (PEI), or a combination of these modalities. Therefore, there is some support in the literature for expanding the UNOS stage restrictions and also for the utility of tumor down staging or treatment prior to transplant. There is the additional concern of tumor growth while awaiting transplant. If a tumor grows beyond the UNOS size requirements while the patient is waiting for transplant then the exception points are withdrawn. Pretransplant tumor treatment is therefore employed as a strategy to prevent waiting list dropout due to tumor growth. At the University of Iowa pre-liver transplant tumor treatment has been used to downstage tumors into parameters that are acceptable to obtain MELD exception points and also to prevent wait list dropout. It is not known if pretransplant treatment of larger stage tumors affords survival that is equivalent to standard criteria tumors or if treatment is necessary to prevent waitlist dropout. The purpose of this retrospective review is to analyze the outcomes of patients whose tumors have been treated prior to transplant and compare these outcomes with those among patients who received no tumor treatment prior to transplant. New initiatives to Maximize Benefits from Pediatric Kidney Donors. Investigator initiated The focus of this project is to study factors that may improve use of pediatric donor organs. The first aim of this project is to develop an effective protocol for the identification of neonatal and pediatric organ donors and achieve excellent consent rates. The second aim is to implement and test the administrative and surgical protocols that we have developed for heart-beating and non-heart- beating neonatal and pediatric organ donors. The third aim is to develop preliminary data on stress- activated protein kinases (SAPKs) in the pathogenesis of renal ischemia-reperfusion injury that may play a role in pediatric transplant failure. In summary, in Aim One we intend to increase procurement of kidneys for donation from the pediatric age group, in Aim Two we propose to increase the use of pediatric kidneys for organ transplantation, while in Aim Three we will begin pilot experimental studies that will lead to future clinical studies and ultimately increase renal graft survival rates, particularly those procured from children.
Date Last Modified: 06/07/2014 -
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