McGowan Institute for Regenerative Medicine affiliated faculty member Abhinav Humar, MD, Clinical Director of the Thomas E. Starzl Transplantation Institute, Chief, Division of Transplantation in the Department of Surgery at the University of Pittsburgh Medical Center, Professor in the Department of Surgery at the University of Pittsburgh School of Medicine, and a Staff Physician at the Pittsburgh VA Medical Healthcare System, is the principal investigator of the clinical trial entitled, “Safety and Preliminary Efficacy of Donor-derived Regulatory Dendritic Cell (DCreg) Infusion and Immunosuppression Withdrawal in Living Donor Liver Transplantation” (ClinicalTrials.gov Identifier: NCT03164265).
Gina Kolata is a New York Times writer who tells the story of Dr. Humar’s first clinical trial participant and the patient’s experience over the past two years. She notes, “Patients receiving new kidneys and livers must take damaging anti-rejection drugs for the rest of their lives. Now researchers hope to train the immune system instead of just tamping it down.”
“You are trying to fool the body’s immune system,” Dr. Humar said. “That is not easy to do.”
The Phase I/II cohort study includes low risk living donor liver transplant recipients who will receive a single infusion of donor-derived DCreg with concurrent mycophenolic acid (MPA) therapy (1/2 dose) one week prior to transplantation. All patients will be maintained on MPA and Tacrolimus (TAC, an immunosuppression drug) for the first six months after transplantation. At that time point, recipients meeting specific criteria (no rejection and permissive liver function tests (LFTs)) will be slowly weaned off MPA per standard of care over a period of six months. Participants will then be evaluated for TAC weaning at one year after transplantation. Those who meet the criteria of no rejection and permissive LFTs will undergo a protocol liver biopsy and proceed to TAC weaning over six months if liver biopsy is permissive. Successfully weaned participants who remain rejection-free will undergo 3 years of follow-up after the last dose of immunosuppression. They will undergo a liver biopsy at one and three years after immunosuppression withdrawal. Participants who are removed from the study protocol at any time will return to standard of care but will continue to be followed by the study team and will undergo a liver biopsy at the end of the study (4.5 years after transplantation).
Angus Thomson, PhD, DSc, Distinguished Professor of Surgery and Immunology, University of Pittsburgh, is the study’s responsible party.