Umbilical Cord Mesenchymal Stem Cell Therapy for Biliary Atresia

Direct Bilirubin Level

Measurement of direct bilirubin level

Time frame: Baseline, Post-Operative Day 7, Post-Operative Day 30, Post-Operative Day 90, Post-Operative Day 180

Indirect Bilirubin Level

Measurement of indirect bilirubin levels

Time frame: Baseline, Post-Operative Day 7, Post-Operative Day 30, Post-Operative Day 90, Post-Operative Day 180

AST (Aspartate Transaminase) Levels

Hepatocellular injury marker

Time frame: Baseline, Post-Operative Day 7, Post-Operative Day 30, Post-Operative Day 90, Post-Operative Day 180

ALT(Alanine Transaminase) Levels

Hepatocellular injury marker

Time frame: Baseline, Post-Operative Day 7, Post-Operative Day 30, Post-Operative Day 90, Post-Operative Day 180

Gamma-glutamyl Transferase (GGT)

Cholestasis marker

Time frame: Baseline, Post-Operative Day 7, Post-Operative Day 30, Post-Operative Day 90, Post-Operative Day 180

Serum Albumin Level

Marker of liver synthesis function and nutrition status

Time frame: Baseline, Post-Operative Day 7, Post-Operative Day 30, Post-Operative Day 90, Post-Operative Day 180

Prothrombin Time (PT), INR

Coagulation parameter to assess liver synthesis function

Time frame: Baseline, Post-Operative Day 7, Post-Operative Day 30, Post-Operative Day 90, Post-Operative Day 180

Complete Blood Count

Hematology panel including hemoglobin, leukocyte count, platelet count, absolute neutrophil count (ANC), and hematocrit.

Time frame: Baseline, Post-Operative Day 7, Post-Operative Day 30, Post-Operative Day 90, Post-Operative Day 180

Pediatric End-Stage Liver Disease-Creatinine (PELD-Cr) Score

The Pediatric End-Stage Liver Disease-Creatinine (PELD-Cr) score is used to assess liver disease severity and estimate mortality risk in pediatric patients with end-stage liver disease. In accordance with Organ Procurement and Transplantation Network (OPTN) policy, the minimum score for this scale is capped at 6 (any calculated laboratory score below 6 is reported as 6), and there is no upper limit or maximum score. Higher PELD-Cr scores indicate greater liver disease severity and a worse clinical prognosis.

Time frame: Baseline, Post-Operative Day 7, Post-Operative Day 30, Post-Operative Day 90, Post-Operative Day 180

Jaundice Clearance

Postoperative jaundice resolution, assessed through clinical evaluation and total/direct serum bilirubin levels.

Time frame: Baseline, Post-Operative Day 7, Post-Operative Day 30, Post-Operative Day 90, Post-Operative Day 180

Liver Fibrosis Stages

Evaluated by measuring liver stiffness via Acoustic Radiation Force Impulse (ARFI) ultrasound, mapped to the METAVIR Fibrosis Staging Scale. The scale ranges from a minimum score of 0 (F0: no fibrosis) to a maximum score of 4 (F4: cirrhosis). Higher scores indicate greater liver fibrosis severity and a worse clinical outcome.

Time frame: Baseline, Post-Operative Day 7, Post-Operative Day 30, Post-Operative Day 90, Post-Operative Day 180

Regulatory T-cell (Treg) levels

Regulatory T-cell (Treg) levels as an immunological parameter, measured postoperatively using flow cytometry and reported in standard laboratory units.

Time frame: Post-Operative Day 7

CD11c Levels

CD11c-positive immune cell marker levels, measured postoperatively via flow cytometry and reported in standard laboratory units.

Time frame: Post-Operative Day 7

Postoperative Cholangitis Incidence

Incidence of postoperative cholangitis, diagnosed based on clinical symptoms, physical examination, and supporting diagnostic tests as evaluated by the attending physician.

Time frame: Baseline, Post-Operative Day 7, Post-Operative Day 30, Post-Operative Day 90, Post-Operative Day 180

Length of Stay

Calculated as the number of consecutive days from the date of surgery to the date of initial hospital discharge or in-hospital death during the index hospitalization. Re-admissions following initial discharge are excluded.

Time frame: From the date of surgery until initial hospital discharge or death during the same period of care with the surgery, whichever occurs first (assessed up to 12 months).

All-Cause Mortality

Evaluated as the incidence of death from any cause occurring during the study period. Cause of death are verified through electronic medical record documentation, official death certificates, or direct patient/family follow-up contact.

Time frame: From the date of study enrollment until death, assessed up to 12 months.