Intraperitoneal transplant of Hepatocytes co-Encapsulated with mesenchymal stromal cells in modified alginate microbeads for the treatment of acute Liver failure in Pediatric patients (HELP)-An open-label, single-arm Simon's two stage phase 1 study protocol.

Background: Pediatric acute liver failure (PALF) carries a high mortality without liver transplantation (LT) in children. Liver transplantation, though lifesaving, is limited by timely donor organ availability, the risks of major surgery and complications of life-long immunosuppression. Hepatocyte transplantation (HT) improves synthetic and detoxification functions in small animal models.