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
Tel:  215-614-0528
Email:  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
Tel:  215-614-0528
Email:  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
Tel:  215-614-0528
Email:  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
Tel:  215-614-0528
Email:  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
Tel:  215-614-0528
Email:  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
Tel:  215-614-0528
Email:  Mary.Shaw@uphs.upenn.edu

PERT Study:  The Use of Peri-operative Intravenous Estrogen for the Mitigation of Ischemia Reperfusion Injury in the Setting of Renal Transplantation

PI:  Matthew Levine, MD, PhD

The purpose of this study is to see if giving intravenous (IV) estrogen at the time of kidney transplant will help the kidney work properly after it is transplanted.  Sometimes after a kidney is transplanted, the kidney does not work as it should right away.  When this happens, patients typically require dialysis treatments within the first week after transplant. 

When the transplanted kidney does not work right away, there can be increased medical costs, increased length of hospital stay and decreased graft (kidney) survival.  Currently there are no preventative measures or treatments though dialysis is used until recovery of kidney function occurs.  Some research studies in mice have shown a more positive outcome in female compared to male mice.  Research in this area has focused on hormonal effects of estrogen and testosterone.

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

Optimal Study:  Evaluation of Donor Specific Immune Senescence and Exhaution as Biomarkers of Operational Tolerance Following Liver Transplantation in Adults

PI: Abraham Shaked, MD, PhD

People who have liver transplants must take anti-rejection medication (immunosuppression) for the rest of their lives.  If they stop, their immune system may reject the transplanted liver.  All anti-rejection medications have side effects.  Anti-rejection medications make it hard for your body to fight off infections.  In addition, they can cause high blood pressure, kidney damage, plaque build-up in the blood vessels, high cholesterol, diabetes and bone disease.  They may make you more likely to get some types of cancer (mainly cancer of the white blood cells and/or skin) and other serious side effects.

Because of the side effects of anti-rejection medications, an important goal of transplant research is to allow people to accept their transplanted organ without long term use of anti-rejection medications.  In this study, anti-rejection medication(s) will be gradually reduced over a period of time and then stopped.  The study calls this “immunosuppression withdrawal”.  The purpose of this research study is to see how many people will develop tolerance after immunosuppression withdrawal.  The researchers also want to find out if there are blood or liver biopsy tests that can help transplant doctors in the future predict whether it is safe to decrease or stop anti-rejection medications in people who received a liver transplant.  In previous research studies, about half of the participants were able to stop their anti-rejection medication(s) completely without experiencing organ rejection.  However, the likelihood of the same success in this research study is not yet known.

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

Randomized Controlled Trial to Evaluate the Effect of Lost Wage Reimbursement to Potential Kidney Donors on Living Donation Rates (Donor Lost Wages Study)

PI:  Paige Porrett, MD, PhD

This research study is being done to learn if reimbursing a living kidney donor will increase the likelihood that a potential donor will donate a kidney.  In summary, kidney donation can be expensive for donors, particularly if they lose wages while they are off work during the donation evaluation and surgery process.  The researchers would like to find out if removing financial barriers to donation will help improve the chances that a donor might go on to donate a kidney. This study is being sponsored by the Laura and John Arnold Foundation.  If you are randomized to the treatment arm of the study and you have a living donor that volunteers and completes donation to you, The Foundation will pay for your donor’s lost wages from work (up to a certain financial limit).

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

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