Trials / Not Yet Recruiting
Not Yet RecruitingNCT07011199
Clinical Outcomes of Early Kasai Surgery With Umbilical Cord MSCs in Biliary Atresia
Evaluation of Clinical Outcomes in Biliary Atresia Patients Undergoing Kasai Surgery Before 90 Days of Age With Umbilical Cord-Derived Mesenchymal Stem Cell Therapy
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (estimated)
- Sponsor
- Universitas Diponegoro · Academic / Other
- Sex
- All
- Age
- 0 Days – 90 Days
- Healthy volunteers
- Not accepted
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.
Conditions
- Biliary Atresia
- Kasai Portoenterostomy
- Mesenchymal Stem Cell Transplantation
- Liver Function Disorders
- Liver Fibrosis
- Survival Rate
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | 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. |
| PROCEDURE | Kasai Portoenterostomy | Surgical procedure to create a portoenterostomy for biliary drainage in infants with biliary atresia. |
Timeline
- Start date
- 2025-06-17
- Primary completion
- 2026-04-17
- Completion
- 2026-04-17
- First posted
- 2025-06-08
- Last updated
- 2025-06-08
Locations
1 site across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT07011199. Inclusion in this directory is not an endorsement.