Penn Medicine performs research and clinical trials to enhance the treatment and care of patients with liver transplants.

Penn's active research and clinical trials provide additional resources for liver transplant patients. See below for liver clinical trials conducted at Penn.

Effects of Rapamycin on Gene Expression and Biomarkers Associated with Aging

Investigator: Abraham Shaked, MD, PhD

Researchers at the University of Pennsylvania would like to learn about the effect of Sirolimus (or Rapamune) medication on aging. Recent studies have shown that Rapamycin extends lifespan and prevents aging-related diseases in worms, flies, and mice. Since certain liver transplant patients are on Sirolimus medication while other transplant patients are on Tacrolimus (or Prograf) medication we would like to investigate the differences between these patients. A group of healthy volunteers will serve as a control for this study. Researchers will be analyzing blood samples for differences in gene expression. In addition, the study includes computerized cognitive assessments as well as photographs.

Research Coordinator: Mary Shaw, RN, BBA at 215-614-0528 or Mary.Shaw@uphs.upenn.edu

Penn Transplant Biobank and Registry (BioTip)

Investigator: Kim Olthoff, MD

The purpose of the study is to see if substances in the donor organ can predict how well the organ will function after transplant. Tests on blood, urine and biopsy tissue samples will be used in this study to see if such a link exists. Patients who are expected to receive other organs (kidney, lung and heart) will also be part of this study. The research team will be looking at any injuries in the transplanted organs to see if there are similarities among the different organ groups. In this way, they hope to develop a better understanding of organ injury after transplant. Study participation lasts for the lifetime of the participant.

Research Coordinator: Mary Shaw, RN, BBA at 215-614-0528 or Mary.Shaw@uphs.upenn.edu

Predictors of Renal Dysfunction Following Liver Transplantation

Investigator: Peter Abt, MD

10 to 20% of liver transplant recipients develop kidney problems after their liver transplant. This is a research study for individuals who are going to receive either a liver transplant or a simultaneous liver and kidney transplant. The purpose of this study is to help physicians understand which liver transplant recipients are likely to develop kidney problems after transplant. Tests of urine, blood, and tissue biopsy from the kidney will be used to determine who is at risk for kidney dysfunction after the liver transplant.

Research Coordinator: Mary Shaw, RN, BBA at 215-614-0528 or Mary.Shaw@uphs.upenn.edu

A Phase II Randomized Multicenter Placebo-Controlled Blinded Study of Sorafenib Adjuvant Therapy in High Risk Orthotopic Liver Transplant (OLT) Recipients with Hepatocellular Carcinoma (HCC)

Investigator: Kim Olthoff, MD

Hepatocellular carcinoma (HCC) (liver cancer) is a significant health problem, accounting for more than 1,000,000 new cases every year world-wide and is the third leading cause of cancer deaths in the world. The incidence of liver cancer is also increasing in the United States and causes about 13,000 deaths yearly. Outcomes for patients with HCC have been historically poor, regardless of treatment. Liver transplantation is a treatment option for liver cancer patients, but despite transplantation, the HCC (liver cancer) can recur in the new transplanted liver. Nexavar® (sorafenib) is approved by the Food and Drug Administration (FDA) for treatment of patients with advanced kidney cancer and advanced unresectable (untreatable with surgery) liver cancer (HCC). It is not known whether sorafenib, the study medication, is effective in preventing cancer recurrence in high risk patients following liver transplantation. The purpose of this study is to determine if sorafenib is a safe and effective treatment option for preventing liver cancer in high risk patients following liver transplantation.

Research Coordinator: Mary Shaw, RN, BBA at 215-614-0528 or Mary.Shaw@uphs.upenn.edu

Models for Optimal Liver Transplant Outcomes Study

Investigator: Peter Abt, MD

At the time of liver transplantation, some patients have normal kidney function and some patients have poor kidney function. In some patients, the kidney function may improve with time but at this time it is unknown which patients will have improved function and which patients will not. The purpose of this study is to assist physicians understand which liver transplant recipients are likely to develop kidney problems after transplant. Patients who are listed for a liver transplant are eligible to participate in this study. Tests of urine, blood and tissue biopsy from the kidney will be used to determine who is at risk for kidney dysfunction after the liver transplant.

Research Coordinator: Mary Shaw, RN, BBA at 215-614-0528 or Mary.Shaw@uphs.upenn.edu

A 36 Month, Multi-Center, Open-Label, Randomized, Comparator Study To Evaluate The Efficacy and Safety of Everolimus Immunosuppression Treatment in Liver Transplantation for Hepatocellular Carcinoma Exceeding Milan Criteria

Investigator: Maarouf Hoteit, MD

Liver transplantation is an effective therapy approach in patients with hepatocellular carcinoma (HCC) and cirrhosis. Using the Milan tumor inclusion criteria, both patient and graft survival of patients with HCC are similar to those of patients without HCC. The same has been observed with more expanded tumor inclusion criteria. However, while imaging has improved, some of the patients have more tumor burden in the liver transplant than seen on imaging. Tumor size and number has correlated with worse outcome. The same applies to tumor differentiation and vascular invasion; both pathological parameters cannot be reliably predicted based on pre-transplant testing. While post-transplant tumor recurrence has decreased over the years, it is still of concern, as it typically leads to patient demise. Therefore, all attempts should be made to decrease the likelihood of tumor recurrence. This study is to evaluate use of everolimus and tacrolimus in a prospective manner to see if the use of these two medications results in lower tumor recurrence and better patient survival than tacrolimus and mycophenolic acid/mycophenolate mofetil after liver transplantation for HCC.

Research Coordinator: Mary Shaw, RN, BBA at 215-614-0528 or Mary.Shaw@uphs.upenn.edu

ALLTOL Study: A Prospective Cohort Study of Operationally Tolerant Allograft Recipients

Investigator: Abraham Shaked, MD, PhD

Evidence that not all patients require perpetual immunosuppression to maintain their graft is found in a small subset of patients. For kidney transplant recipients, this is estimated to be about 5-10%, for liver transplant recipients it has traditionally been estimated at 20%. However, recent studies demonstrate that the prevalence of operational tolerance may be as high as 40% in adult liver recipients and as high as 60% in a highly selected cohort of pediatric liver recipients. The objective of this study is to identify and follow individuals who have received a kidney or liver transplant and who have achieved a state of operational tolerance to their transplanted organ. Eligible participants will have undergone kidney or liver transplant, have not taken any immunosuppression for at least one year and have had no evidence of graft rejection in the one year prior to enrolling in the study. Participants will also have normal graft function. Testing includes blood, urine and stool collection once a year for the duration of the study. This study will end in January 2021.

Research Coordinator: Mary Shaw, RN, BBA at 215-614-0528 or Mary.Shaw@uphs.upenn.edu

A Multicenter Randomized Controlled Trial to Compare the Efficacy of Ex-vivo Normothermic Machine Perfusion With Static Cold Storage in Human Liver Transplantation

Investigator:  Peter Abt, MD

Over the last two decades, liver transplantation has become a victim of its own success:  many patients are referred for transplantation but the number of suitable organs from deceased organ donors has increased more slowly.  This shortage is the principal cause of increasing waiting lists and the death of patients on the waiting list worldwide.  Due to the critical shortage of donor organs, clinicians are continually searching for ways to overcome the discrepancy between demand and availability of donor livers for transplantation.  This study is looking at liver preservation techniques once the liver is removed from the donor but before it is transplanted into the recipient.  An investigational device called OrganOx metra®, uses a new method to store the liver at normal body temperature during transport between the donor and the recipient.  The traditional method uses the standard cold storage.  In this study, the researchers want to see if the investigational device provides an improved functioning state of the liver during transport.

Research Coordinator: Mary Shaw, RN, BBA at 215-614-0528 or Mary.Shaw@uphs.upenn.edu
Share This Page: