Clinical trial NCT07011199: Clinical Outcomes of Early Kasai Surgery With Umbilical Cord MSCs in Biliary Atresia
Official title: Evaluation of Clinical Outcomes in Biliary Atresia Patients Undergoing Kasai Surgery Before 90 Days of Age With Umbilical Cord-Derived Mesenchymal Stem Cell Therapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Biliary Atresia
Kasai Portoenterostomy
Mesenchymal Stem Cell Transplantation
Liver Function Disorders
Liver Fibrosis
Survival Rate
Lead sponsor: Universitas Diponegoro
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 14
Sex: ALL
Minimum age (years): 0
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Serum Albumin Level
timeFrame: Baseline (Pre-op), 4 weeks, 6 weeks, 12 weeks, 24 weeks, and 12 months post-operation
measure: Total Bilirubin Level
timeFrame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
measure: Gamma Glutamyl Transferase (GGT)
timeFrame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
measure: Alanine Aminotransferase (ALT)
timeFrame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
measure: Aspartate Aminotransferase (AST)
timeFrame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
measure: Prothrombin Time (PT), aPTT, INR
timeFrame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
measure: Alpha Fetoprotein (AFP)
timeFrame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
measure: Alkaline Phosphatase (ALP)
timeFrame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
measure: Lactate Dehydrogenase (LDH)
timeFrame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
Secondary outcomes:
measure: Anemia Status
timeFrame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
measure: Ascites
timeFrame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
measure: Jaundice Status
timeFrame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
measure: Pediatric End-Stage Liver Disease (PELD) Score
timeFrame: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months
measure: Overall Survival (OS)
timeFrame: From the surgery date up to the end of the study (12 months maximum follow-up)
Other outcomes:
Locations:
city: Semarang
country: Indonesia
facility: Dr. Kariadi General Hospital Medical Center
state: Central Java
Study officials:
affiliation: Dr. Kariadi General Hospital Medical Center
name: Avriana Pety Wardani, MD, Sp.BA
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr. Kariadi General Hospital Medical Center
name: Erik Prabowo, Dr, MD, M.Si.Med, Sp.B-KBD
role: STUDY_DIRECTOR
affiliation: Universitas Diponegoro
name: Kevin Christian Tjandra, MD
role: STUDY_CHAIR
affiliation: Universitas Diponegoro
name: Danendra Rakha Putra Respati, MD
role: STUDY_CHAIR
References: