Immune Tolerance Network - OPTIMAL

Investigator: Sandy Feng, MD, PhD
Sponsor: Benaroya Research Inst at Virginia Mason

Location(s): United States


The Immune Tolerance Network (ITN) opened the OPTIMAL Study for liver transplant recipients at the first clinical site, the University of California, San Francisco on Monday, October 26, 2015. The OPTIMAL Study (Operational Tolerance Biomarkers of Immune Senescence and Lymphocyte Exhaustion Following Adult Liver Transplantation) will enroll 60 adult liver transplant recipients. These recipients will undergo supervised, gradual withdrawal of their immunosuppressive medications.

An important goal of transplant research is to allow people with a transplanted organ to live without long-term use of immunosuppression, which has serious side effects including increased risk of infection and malignancy. Previous research suggests that a proportion of liver transplant recipients are able to come off immunosuppressive drugs without experiencing rejection. The goal of the OPTIMAL study is to gradually reduce anti-rejection medications in liver transplant recipients to help determine how many participants can achieve a state of operational tolerance.

The OPTIMAL investigators also hypothesize that continual exposure to a transplanted organ for a significant period of time may render the immune system “exhausted,” thereby tempering the associated inflammatory response.  For this reason, the OPTIMAL study will enroll transplant recipients who have been living with their transplanted liver for at least three years, and will assess whether biomarkers of an exhausted immune system can help predict individuals who can successfully discontinue immunosuppressive medication without experiencing damage to their transplanted organ.