Набор скоро начнётся NCT07011199

Clinical Outcomes of Early Kasai Surgery With Umbilical Cord MSCs in Biliary Atresia

Фаза I С лечением Biliary Atresia Kasai Portoenterostomy Mesenchymal Stem Cell Transplantation Liver Function Disorders

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs), Kasai Portoenterostomy.
Кому может быть актуально: Состояния в реестре: Biliary Atresia, Kasai Portoenterostomy, Mesenchymal Stem Cell Transplantation, Liver Function Disorders. Базовые параметры: 0 Days — 90 Days · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Индонезия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Evaluation of Clinical Outcomes in Biliary Atresia Patients Undergoing Kasai Surgery Before 90 Days of Age With Umbilical Cord-Derived Mesenchymal Stem Cell Therapy

Обзор

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.

Вмешательства

Биопрепарат 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.
Процедура Kasai Portoenterostomy
Surgical procedure to create a portoenterostomy for biliary drainage in infants with biliary atresia.

Первичные конечные точки

Serum Albumin Level [Срок оценки: Baseline (Pre-op), 4 weeks, 6 weeks, 12 weeks, 24 weeks, and 12 months post-operation]
Total Bilirubin Level [Срок оценки: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months]
Gamma Glutamyl Transferase (GGT) [Срок оценки: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months]
Alanine Aminotransferase (ALT) [Срок оценки: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months]
Aspartate Aminotransferase (AST) [Срок оценки: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months]
Prothrombin Time (PT), aPTT, INR [Срок оценки: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months]
Alpha Fetoprotein (AFP) [Срок оценки: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months]
Alkaline Phosphatase (ALP) [Срок оценки: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months]
Lactate Dehydrogenase (LDH) [Срок оценки: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months]

Вторичные конечные точки (5)

Anemia Status [Срок оценки: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months]
Ascites [Срок оценки: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months]
Jaundice Status [Срок оценки: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months]
Pediatric End-Stage Liver Disease (PELD) Score [Срок оценки: Baseline, 4 weeks, 6 weeks, 12 weeks, 24 weeks, 12 months]
Overall Survival (OS) [Срок оценки: From the surgery date up to the end of the study (12 months maximum follow-up)]

Критерии участия

Критерии включения

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.