MedStar Georgetown Transplant Institute

Clinical Research

Tomorrow’s Treatments, Today

Research is a critical part of what we do at MedStar Georgetown University Hospital, as we are always searching for innovative ways to treat and manage advanced disease and transplantation surgery.

Research is conducted under the oversight of Dr. Thomas Fishbein, M.D. Executive Director of MedStar Georgetown Transplant Institute. Clinical Trials are led by highly skilled Surgeons and Clinicians as Primary Investigators (P.I.) who specialized in Transplant. We are committed to bringing basic research into medical and nursing practice to produce meaningful health outcomes to improve medicine.

All of our studies are presented at regional, national, and international meetings and are published in peer-reviewed scientific journals. We are committed to advancing the art and science of transplantation and to improving the quality of patients' lives through systematic investigation.

Locations

Dr. Thomas Fishbein

Dr. Thomas Fishbein

Dr. Fishbein is the executive director of MedStar Georgetown Transplant Institute (MGTI), director of Liver Diseases and Transplant Program and professor, Departments of Surgery and Pediatrics. Board certified in Surgery, his special interests include small bowel/intestinal transplantation, pediatric liver transplantation, hepatobiliary surgery, liver transplant, portal hypertension surgery and pancreatic surgery. He oversees clinical research at MGTI and is the principal investigator of numerous clinical trials. Dr. Fishbein is known as one of a handful of international experts on intestinal transplantation who has developed new immunosuppressive regimens, surgical techniques and other treatments to improve outcomes.

Intestinal/Liver Transplantation

Biomarkers for Post –Transplant Lymphoproliferative Disorders in Children

Purpose:    To study the differences in the EBV virus to help identify features that will determine if a person has a higher chance of developing PTLD.  Also, to study the changes in the immune system’s response to the EBV virus that can help determine which people will develop PTLD; and develop a test that would detect PTLD very early to allow for better treatment.
Location:    MedStar Georgetown University Hospital

Multicenter Validation of a Novel Prognostic Nomogram to Predict Post-transplant HCC Recurrence

Purpose:    To develop a quantitative model for predicting hepatocellular carcinoma recurrence in patients undergoing liver transplant. We hypothesize that there will be a number of significant variables correlated to HCC recurrence and that a quantitative regression model can be developed to help guide perioperative treatment of these patients undergoing orthotropic liver transplant.
Location:    MedStar Georgetown University Hospital

A Prospective, Randomized, Double-blind, Phase II Study to Evaluate the Safety and Efficacy of Topical Thrombin (Human) Grifols as an Adjunct to Hemostasis during Vascular, Parenchymous, Soft Tissue, and Spinal Open Surgeries

Purpose:    To evaluate the safety and the hemostatic efficacy of plasma-derived Topical Thrombin (Human) Grifols in vascular, parenchymous, soft tissue, and spinal open surgeries.
Location:    MedStar Georgetown University Hospital

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)

Purpose:    Evaluating adjuvant therapy after resection or liver transplantation for HCC, especially in the high risk patients.
Location:    MedStar Georgetown University Hospital

Clinical Investigation of Inflammatory Bowel Diseases, Intestinal Failure and Transplantation

Purpose:    To properly determine and compare the microbial interaction with the small bowel mucus barrier of NOD2 mutant vs. NOD2 WT patients, following intestinal allograft transplantation.
Location:    MedStar Georgetown University Hospital

Dr. Matthew Cooper

matthew cooper

Primary Investigator Dr. Matthew Cooper is the director of Kidney and Pancreas Transplantation at the MedStar Georgetown Transplant Institute (MGTI), the medical director of Perioperative Services at Medstar Georgetown University Hospital and a Professor of Surgery at Georgetown University School of Medicine. Dr. Cooper is board certified in general surgery and accredited by the American Society of Transplant Surgeons.

 

Kidney and Pancreas Transplantation 

The use of the Prevena™ Incision Management System on Closed Recipient Site Incisions in Renal Transplant Subjects

Purpose:    To compare short-term surgical incision-related clinical outcomes in Subjects undergoing open renal transplant surgery when managed with PIMS versus a SOC surgical incision dressing.
Locations:    MedStar Georgetown University Hospital
MedStar Washington Hospital Center

A Pilot Study Comparing the Safety and Efficacy of Zortress (Everolimus) With Low Dose Tacrolimus to Early Conversion to Calcineulin Inhibitor-Free Regimen and Mycophenolic acid With Standard Dose Tacrolimus in Recipients of DCD and KDPI Kidneys.  Assessment of Zortress (EVErolimus) in Recipients of Elevated KDPI and DCD kidneys - EVERED Trial

Purpose:    To evaluate the efficacy and safety of everolimus (1.5 mg/day) with standard therapy in recipients of DCD and kidneys from donors with Kidney Donor Profile Index greater than 70.
Locations:    MedStar Georgetown University Hospital
MedStar Washington Hospital Center

A Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Multi-Center Study of Eculizumab for the Prevention of Delayed Graft Function after Kidney Transplantation in Adult Subjects at Increased Risk of Delayed Graft Function

Purpose:    To demonstrate the efficacy and safety of a 2-dose regimen of eculizumab given to prevent DGF in adult recipients of deceased donor kidney transplant who are at increased risk of DGF.
Location:    MedStar Georgetown University Hospital

A Prospective Observational Trial to Evaluate the Correlation of T-SPOT® Response to CMV Infection and T cell-mediated Acute Graft Rejection

Purpose:    Evaluate the utility of T-SPOT.CMV assay in the management of post-transplant patients through the monitoring of T cell immune response to CMV antigens.
Locations:    MedStar Georgetown University Hospital
MedStar Washington Hospital Center

A Three-Part, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Sequential Adaptive, Phase II Study to Evaluate the Safety, Tolerability and Efficacy of OPN-305, a Humanized Monoclonal Antibody that Blocks Toll-Like Receptor 2, in Renal Transplant Patients at High Risk of Developing Delayed Graft Function

Purpose:    To investigate whether an investigational drug, OPN-305, can prevent delayed graft function (DGF) or slow graft function (SGF) for those undergoing a kidney transplant. 
Locations:    MedStar Georgetown University Hospital
MedStar Washington Hospital Center

Dr. Alexander Gilbert

Alexander Gilbert

Primary Invesigator Alexander Gilbert, MD, has expertise in both the pre- and post-surgical management of transplant patients, as well as managing living kidney donors.

Kidney and Pancreas Transplantation

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 transplantpatients

Purpose:    To evaluate the efficacy investigational drug given intravenously in 7 doses over 13 days as an adjunct to plasmapheresis, plasma exchange, and/or immune adsorption treatments and intravenous immunoglobulin (IVIg) for the treatment of acute antibody-mediated rejection (of renal allograft) (AMR) in kidney transplant recipients as measured by the proportion of subjects with new or worsening transplant glomerulopathy (TG) within 6 months.
Locations:    MedStar Georgetown University Hospital
MedStar Washington Hospital Center

Dr. Monica Grafals

monica grafals

 Primary Invesigator Dr. Monica Grafals is a member of the MedStar Georgetown Transplant Institute.

Kidney and Pancreas Transplantation

Use of Acthar in CKD stage V or ESRD patients in preparation for a kidney transplant

Purpose:  Prospective study evaluating the efficacy of treatment of nephrotic syndrome in renal transplant recipients with the primary native kidney disease of focal glomerular sclerosis (FSGS).
Location:  MedStar Georgetown University Hospital

Dr. Rohit Satoskar

Satoskar

 Primary Investigator Dr. Rohit Satoskar is a member of the MedStar Georgetown Transplant Institute.

Liver Disease and Transplantation

A Phase III Double Blind Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects with Chronic HCV GT1, GT4 and GT6 Infection with Inherited Blood Disorders with and without HIV Co-Infection

Purpose:    To evaluate the efficacy of MK-5172A as assessed by the proportion of subjects in the treatment arm achieving Sustained Virologic Response 12 weeks after the end of all study therapy in patients with blood disorders (Hemophilia A&B, von Willebrand, Sickle Cell, Beta Thalassemia).
Location:    MedStar Georgetown University Hospital

ECOG-ACRIN: A Prospective, Multicenter Comparison of Multiphase Contrast-Enhanced CT and Multiphase Contrast-Enhanced MRI for Diagnosis of Hepatocellular Carcinoma for Liver Transplant Allocation

Purpose:    To evaluate modern imaging technology and its ability to accurately diagnose and stage hepatocellular carcinoma (HCC) in patients with chronic liver disease when performed on state-of-the-art multi-detector computed tomography (CT) or magnetic resonance imaging (MRI) equipment, with contemporary multiphase contrast-enhanced imaging protocols.
Location:    MedStar Georgetown University Hospital

Dr. Coleman Smith

Dr.ColemanSmithprofile

Primary Investigator Dr. Coleman Smith is a member of the MedStar Georgetown Transplant Institute.

Liver Disease and Transplantation

HCV-TARGET: Hepatitis C Therapeutic Registry and Research Network-A Longitudinal, Observational Study

Purpose:    HCV-TARGET is a research registry of sequential patients treated for chronic HCV within academic and community real-world practices designed to rapidly inform strategies for better management of populations underrepresented in clinical trials, to identify and remediate educational gaps relative to treatment guidelines and adverse event management in order to optimize rates of SVR, and to serve as the core resource for important collaborative translational studies utilizing biospecimens and clinical data from diverse patient populations.
Location:    MedStar Georgetown University Hospital
MedStar Washington Hospital Center
Fairfax

A Multicenter, Double-Blind, Sponsor-Open Trial of IDN-6556 in Subjects Who had Hepatitis C Virus (HCV) Reinfection and Liver Fibrosis following Orthotopic Liver Transplantation for Chronic HCV Infection and Who Subsequently Achieved a Sustained Virologic Response Following anti-HCV Therapy

Purpose:    To assess the effect of oral IDN-6556 on fibrosis using the Ishak Fibrosis Score, in subjects with HCV reinfection and liver fibrosis following orthotopic liver transplantation for chronic HCV who subsequently achieved a sustained virologic response following anti-HCV therapy.
Location:    MedStar Georgetown University Hospital

Locations

MedStar Georgetown University Hospital

202-444-3704

3800 Reservoir Road NW
Washington, DC 20007

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MedStar Washington Hospital Center

202-877-6389

110 Irving Street NW
Washington, DC 20010

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MedStar Georgetown Transplant Institute in Fairfax

703-698-9254

3301 Woodburn Road
Annandale, VA

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