On Oct. 14, 2025, researchers at Cincinnati Children’s in collaboration with Roche, have developed a next-generation human liver organoid microarray platform that that could help predict which drugs may cause harmful immune reactions in some people.

The study published online Sept. 26, 2025, in the journal Advanced Science describes a miniaturized, fully human liver system built from stem cells and a patient’s own immune cells—a powerful new tool to uncover why some people experience serious, immune-related liver injuries from otherwise safe medications. The study’s co-first author, Fadoua El Abdellaoui Soussi, PhD, and corresponding author, Magdalena Kasendra, PhD, are members of the Center for Stem Cell and Organoid Medicine (CuSTOM) at Cincinnati Children’s.

Some drugs that pass early safety testing can still cause idiosyncratic drug-induced liver injury (iDILI)—a rare immune reaction that can lead to severe illness or even drug withdrawal. Standard lab tests and animal models cannot reproduce these complex, patient-specific immune mechanisms.

The newly developed platform bridges this gap by combining induced pluripotent stem cell (iPSC)-derived liver organoids with each donor’s autologous CD8⁺ T cells—the immune cells responsible for attacking infected or damaged tissue. Together, they form a fully human, immune-competent model that mirrors the genetic and immune diversity of real patients.

As a proof-of-concept, the research team recreated liver injury triggered by the antibiotic flucloxacillin, which occurs only in carriers of the HLA-B*57:01 risk gene. The model reproduced hallmark signs of immune-mediated liver toxicity—including T cell activation, cytokine secretion, and hepatocyte damage—closely matching what occurs in susceptible patients. Cincinnati Children’s has been a global leader in organoid medicine since 2010, when its scientists created the first functional human intestinal organoids.