Clinical Outcomes of Early Kasai Surgery With Umbilical Cord MSCs in Biliary Atresia

Universitas Diponegoro

Status and phase: Not yet enrolling; Phase 1

Conditions: Liver Function Disorders; Kasai Portoenterostomy; Liver Fibrosis; Mesenchymal Stem Cell Transplantation; Survival Rate; Biliary Atresia

Treatments: Procedure: Kasai Portoenterostomy; Biological: Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs)

Study type: Interventional

Funder types: Other

Identifiers

NCT07011199

No.16373/EC/KEPK-RSDK/2025

Details and patient eligibility

About

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.

Enrollment: 14 estimated patients

Sex: All

Ages: Under 90 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Infants with severe malnutrition.
• Infants with major congenital anomalies other than biliary atresia.
• Infants with positive tumor markers.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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14 participants in 2 patient groups, including a placebo group

Intervention Group (UC-MSC Group)

Experimental group

Description:

Participants in this group are infants diagnosed with biliary atresia who undergo Kasai portoenterostomy before 90 days of age. During the operation, they receive intraoperative trans-portal vein injection of umbilical cord-derived mesenchymal stem cells (UC-MSCs) at a dose of 20 million cells diluted in 5 mL autologous plasma.

Treatment:

Biological: Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs)

Procedure: Kasai Portoenterostomy

Control Group (Historical Control Group)

Placebo Comparator group

Description:

Participants in this group are historical patients who previously underwent Kasai portoenterostomy before 90 days of age at the same institution but did not receive UC-MSC therapy. Data for this group is collected retrospectively.

Treatment:

Procedure: Kasai Portoenterostomy