Autologous liver cells mini liver implant for liver cirrhosis treatment: A phase II single center controlled trial

Background: Liver cirrhosis represents a major healthcare burden, with its prevalence continuing to rise. While orthotopic liver transplantation (OLT) remains to be the only treatment, persistent shortage of donor organ contributes to significant waitlist mortality. Hepatocyte transplantation offers a regenerative approach as a bridging therapy to OLT. However, transplantation through portal vein infusion often ends with poor cell engraftment and allogeneic rejection. Herein, we designed a mini liver implant, composed of a 3-dimensional biodegradable poly-L-lactic acid matrix carrying autologous hepatocyte and islets. Methods: A phase II clinical trial was conducted in patients with liver cirrhosis to receive either a mini liver implant or standard treatment (control group). Liver stiffness and steatosis were measured by FibroScan® at baseline, 6-, and 12-months after implantation. Child-Pugh score, MELD (Model for End-stage Liver Disease) score, serum albumin, and other biochemical parameters were assessed at baseline, 2-, 4-, 6-, and 12-months. Results: The implant group demonstrated a progressive reduction in liver stiffness from 19.23 kPa at baseline to 15.33 kPa at 12 months (20.28 % decrease), although not statistically significant. The control group showed worsen liver stiffness from 25.92 kPa to 62.22 kPa (140.05 % increase). Other hepatic parameters, including steatosis, albumin, and liver enzymes, showed no significant differences between groups. The implant was well tolerated with only mild adverse events reported. Overall survival was comparable between both groups. Conclusions: While larger studies are required to confirm efficacy, autologous mini liver implantation shows promise as a regenerative therapy that could delay or complement liver transplantation.