Clinical Outcomes of Early Kasai Surgery With Umbilical Cord MSCs in Biliary Atresia
NCT ID: NCT07011199
Last Updated: 2025-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
14 participants
INTERVENTIONAL
2025-06-17
2026-04-17
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Intervention Group (UC-MSC Group)
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.
Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs)
Intraoperative trans-portal vein injection of 20 million mesenchymal stem cells derived from umbilical cord tissue, suspended in 5 mL autologous plasma.
Kasai Portoenterostomy
Surgical procedure to create a portoenterostomy for biliary drainage in infants with biliary atresia.
Control Group (Historical Control Group)
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.
Kasai Portoenterostomy
Surgical procedure to create a portoenterostomy for biliary drainage in infants with biliary atresia.
Interventions
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Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs)
Intraoperative trans-portal vein injection of 20 million mesenchymal stem cells derived from umbilical cord tissue, suspended in 5 mL autologous plasma.
Kasai Portoenterostomy
Surgical procedure to create a portoenterostomy for biliary drainage in infants with biliary atresia.
Eligibility Criteria
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Inclusion Criteria
* 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 major congenital anomalies other than biliary atresia.
* Infants with positive tumor markers.
0 Days
90 Days
ALL
No
Sponsors
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Universitas Diponegoro
OTHER
Responsible Party
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Avriana Pety Wardani
MD, Sp. BA
Principal Investigators
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Avriana Pety Wardani, MD, Sp.BA
Role: PRINCIPAL_INVESTIGATOR
Dr. Kariadi General Hospital Medical Center
Erik Prabowo, Dr, MD, M.Si.Med, Sp.B-KBD
Role: STUDY_DIRECTOR
Dr. Kariadi General Hospital Medical Center
Kevin Christian Tjandra, MD
Role: STUDY_CHAIR
Universitas Diponegoro
Danendra Rakha Putra Respati, MD
Role: STUDY_CHAIR
Universitas Diponegoro
Locations
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Dr. Kariadi General Hospital Medical Center
Semarang, Central Java, Indonesia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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No.16373/EC/KEPK-RSDK/2025
Identifier Type: -
Identifier Source: org_study_id
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