Clinical trials

Adult to Adult Living Donor Liver Transplantation (A2ALL) Cohort Study – 5U01DK62531

Major goals: This multifaceted study is comprised of a consortium of leading transplant centers whose primary goal is to define the short and long-term risks of morbidity and mortality for the adult donor and to determine the efficacy of this procedure for the adult recipient compared to patients undergoing liver transplant with a cadaveric liver.
Principal investigator: Robert A. Fisher, M.D.
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases/National Institutes of Health (2002-present)
Trial no.: NCT01619475
Contact: Joanne L. Davis at jdavis3@mcvh-vcu.edu

The Use of Human Hepatocyte Transplantation as a Life Support Bridge in Terminal Liver Failure (1993 to present)

Major goals: The purpose of this research is to gain knowledge about the result of infusing liver cells, carefully matched to blood type, into a subject's body. The hope is that this procedure will aid functions of the liver and prevent death, enable a transplant procedure to be carried out if a donated liver becomes available and lessen complications in postoperative recovery.
Principal investigator: Robert A. Fisher, M.D.
Sponsor: Irvin Liver Transplant Research Fund
Trial no.: NCT00805610
Contact: Donna Winborne at dwinborne@mcvh-vcu.edu

LPC-Tacro tablets, once daily, compared to Prograf capsules, twice daily, in combination with Mycophenolate Mefetil for the prevention of acute allograft rejection in De Novo Adult Kidney Transplant – Protocol LCP-3002

Principal investigator: Anne King, M.D.
Sponsor: Veloxis Pharmaceuticals
Trial no.: NCT01187953
Contact: Mary Baldecchi at mbaldecchi@mcvh-vcu.edu

An Observational, Non-Interventional, Multi-Center, Multi-National Study of Patients with Atypical Hemolytic-Uremic Syndrome (aHUS Registry) – Protocol M11-001

Principal investigator: Anne King, M.D.
Sponsor: Alexion Pharmaceuticals
Trial no.: NCT01522183
Contact: Mary Baldecchi at mbaldecchi@mcvh-vcu.edu

A Three-part, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Sequential-adaptive, Phase II Study to Evaluate the Safety, Tolerability and Efficacy of OPN305, a Humanised Monoclonal Antibody that Blocks Toll-like Receptor 2 in Renal Transplant Patients at High Risk of Delayed Graft Function – Protocol OPN305-102

Principal investigator: Adrian Cotterell, M.D.
Sponsor: Opsona Therapeutics
Trial no.: NCT01794663
Contact: Mary Baldecchi at mbaldecchi@mcvh-vcu.edu

Pancreatic Islet Transplantation in Patients with Type 1 Diabetes Mellitus (2007-present)

Major goals: Islet cell transplantation is an experimental treatment for type 1 diabetes mellitus. This procedure involves infusing isolated islets from a donor pancreas into a person with type 1 diabetes. Islets are made up of several types of cells, including beta cells, which make insulin. Insulin is the hormone that helps the body use glucose for energy. In type 1 diabetes, the body’s immune system destroys the beta cells and caused the insulin shortage. After the transplant, the islets begin to produce insulin, which regulates the level of glucose in the blood. To avoid rejection of the transplanted cells, patients take immunosuppressant drug. A growing percentage of patients that have undergone islet transplantation are insulin-independent after one year.
Principal investigator: Adrian Cotterell, M.D.
Trial no.: NCT00784966
Contact: Donna Winborne at dwinborne@mcvh-vcu.edu