Clinical Research Overview

Clinical research is a vital part of the Division's mission to develop new and more effective treatments for transplant patients. Significant milestones have been achieved at UCSF in immunogenetics, immune responses and immunosuppressive therapy. UCSF transplant researchers have been among the most successful in the nation at attracting competitively awarded NIH grants for their work, including studies related to organ preservation, utilization, and allocation; surgical technique; pre and post-transplant medical management; drug investigations, and human immune responses. 

The Division offers patients a broad portfolio of clinical trials. These are led by Principal Investigators (PI), supported by project managers, trial coordinators and a research administration staff. The team has decades of experience in clinical research for transplantation and provides state-of-the-art care to patients who participate in these clinical studies.  

We are also currently conducting several human research studies to evaluate the efficacy and safety of newly developed immunosuppressive agents. These studies aim to determine successful regimens with substitute anti-rejection drugs, while avoiding the severe negative side-effects associated with chronic use of existing drugs such as calcineurin inhibitors (CNIs). Inherent toxicities of CNIs may be contributing to long-term patient death and kidney failure.

One promising immunosuppression treatment for liver transplant  being investigated in clinical trials is a  belatacept. Belatacept, with a novel mechanism of action that provides greater specificity of effect, is non-nephrotoxic and has been shown in several primate models to successfully inhibit the primary immune responses to the allografts without inhibiting the immune system to the point that viral infection or reactivation occurs.

A second novel treatment that is being studied for use as prophylaxis of graft failure is gaseous carbon monoxide for inhalation. Carbon monoxide modulates several intracellular signaling pathways and generates increased levels of anti-inflammatory molecules.

Another goal of current clinical studies is to analyze the effects of withdrawal from immunosuppressive drugs. The clinical and mechanistic outcomes of attempting withdrawal are compared to those in groups whose standard treatments are maintained, the objective being to establish how best to manage immunosuppression in various types of patients.