Modified Kasai operation combined with autologous bone marrow mononuclear cell infusion for biliary atresia

Abstract

Abstract Aim: To evaluate the safety and outcomes of modified Kasai operation combined with autologous bone marrow mononuclear cell (BMMNC) infusion for biliary atresia (BA). Methods: A prospective study was performed from January 2015 to December 2021. Ten consecutive children with BA who underwent modified Kasai operation combined with autologous BMMNC infusion were included. Kasai operation was performed with two modifications: the liver was exteriorized partially, and two hepatic pedicles were encircled and retracted laterally. Bone marrow was harvested through anterior iliac crest puncture under general anesthesia then a modified Kasai operation was performed. After processing, bone marrow mononuclear cells were infused through the umbilical vein at the end of the operation. Serum bilirubin, albumin, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, and prothrombin time were monitored at baseline, six months, twelve months, and the last follow-up (4.5 years) after the operation. In addition, esophagoscopy and liver biopsies were performed on patients whose parents agreed. Mixed-effects analysis was used to evaluate the changes in Pediatric End-Stage Liver Disease (PELD) scores. Results: There were no intraoperative or postoperative complications related to the operation or cell infusion. The average infused BMMNC and CD34+ cell counts per kg bodyweight were 85.5 ± 56.0 x 106/kg and 10.0 ± 3.6 x 106 for the injection, respectively. After the intervention, all ten patients survived with a mean follow-up duration of 4.5 ± 0.9 years. Liver function was maintained or improved after the operation and cell infusion, as assessed by biochemical tests. The severity of the disease reduced markedly, with a significant reduction in PELD scores. Conclusion: Autologous BMMNC administration combined with Kasai operation for BA is safe and may maintain or improve liver function. A randomized study with a control group should be performed to provide accurate conclusions on the efficacy of this approach. ClinicalTrials.gov Identifier: NCT05517317 on August 26th, 2022.