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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group (UC-MSC Group) | Experimental | 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. |
|
| Control Group (Historical Control Group) | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs) | Biological | Intraoperative trans-portal vein injection of 20 million mesenchymal stem cells derived from umbilical cord tissue, suspended in 5 mL autologous plasma. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Albumin Level | Measurement of serum albumin as marker of liver synthetic function | Baseline (Pre-op), 4 weeks, 6 weeks, 12 weeks, 24 weeks, and 12 months post-operation |
| Total Bilirubin Level | Measurement of bilirubin levels (total, direct, indirect) | Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months |
| Gamma Glutamyl Transferase (GGT) | Measurement of liver enzyme levels | Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months |
| Alanine Aminotransferase (ALT) | Liver injury marker | Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months |
| Aspartate Aminotransferase (AST) | Liver injury marker | Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months |
| Prothrombin Time (PT), aPTT, INR | Coagulation parameters | Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months |
| Alpha Fetoprotein (AFP) | Tumor marker | Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months |
| Alkaline Phosphatase (ALP) | Liver and bone function marker |
| Measure | Description | Time Frame |
|---|---|---|
| Anemia Status | Clinical and laboratory evaluation of anemia | Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months |
| Ascites | Clinical evaluation via physical exam and ultrasound |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Avriana Pety Wardani, MD, Sp. BA | Contact | +62 81229515791 | avrianagarg@gmail.com | |
| Kevin Christian Tjandra, MD | Contact | +62 87700771775 | kevinchristian2841@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Avriana Pety Wardani, MD, Sp.BA | Dr. Kariadi General Hospital Medical Center | Principal Investigator |
| Erik Prabowo, Dr, MD, M.Si.Med, Sp.B-KBD | Dr. Kariadi General Hospital Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Kariadi General Hospital Medical Center | Semarang | Central Java | 50244 | Indonesia |
There is no plan to make IPD available. The individual participant data will not be shared due to privacy concerns and ethical considerations related to the protection of identifiable health information of pediatric patients. Data sharing is also restricted by institutional policy and local regulations.
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| Kasai Portoenterostomy | Procedure | Surgical procedure to create a portoenterostomy for biliary drainage in infants with biliary atresia. |
|
| Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months |
| Lactate Dehydrogenase (LDH) | Tissue injury marker | Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months |
| Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months |
| Jaundice Status | Clinical and laboratory bilirubin assessment | Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months |
| Pediatric End-Stage Liver Disease (PELD) Score | Disease severity scoring system | Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months |
| Overall Survival (OS) | Survival rate since intervention | From the surgery date up to the end of the study (12 months maximum follow-up) |
| Kevin Christian Tjandra, MD | Universitas Diponegoro | Study Chair |
| Danendra Rakha Putra Respati, MD | Universitas Diponegoro | Study Chair |
| ID | Term |
|---|---|
| D001656 | Biliary Atresia |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D004065 | Digestive System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008107 | Liver Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011171 | Portoenterostomy, Hepatic |
| ID | Term |
|---|---|
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
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