The goal of this clinical trial with historical control is to evaluate whether umbilical cord-derived mesenchymal stem cell (UC-MSC) therapy can improve clinical outcomes in infants with biliary atresia undergoing Kasai surgery before 90 days of age.
The main questions it aims to answer are:
Does UC-MSC therapy improve liver function parameters (bilirubin, albumin, liver enzymes, coagulation profile)? Does UC-MSC therapy reduce complications such as anemia, ascites, jaundice, and improve PELD scores? Does UC-MSC therapy improve overall survival compared to standard Kasai surgery alone? Researchers will compare the group receiving UC-MSC in 2025-2027 with a historical control group of patients who previously underwent Kasai surgery without UC-MSC therapy.
Participants will:
Undergo preoperative evaluation, including laboratory and imaging tests. Receive Kasai surgery combined with intraoperative trans-portal vein injection of 20 million UC-MSCs.
Be monitored postoperatively through serial laboratory tests, imaging (Fibroscan), and clinical assessments at scheduled intervals.
Be followed up for potential serious adverse events and survival outcomes.
Infants diagnosed with biliary atresia confirmed by intraoperative findings.
Underwent Kasai portoenterostomy at an age less than 90 days.
Parents or legal guardians have provided informed consent to participate in the study and follow all study procedures.
Infants with severe malnutrition.
Infants with major congenital anomalies other than biliary atresia.
Infants with positive tumor markers.
Universitas Diponegoro
Lead sponsor
Dr. Kariadi General Hospital Medical Center
Sponsor institution