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Stem Cell Applications in Biliary Atresia Patients

ConditionsBiliary AtresiaFibrosis, LiverStem Cell
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-18
SponsorNecmi Kadıoğlu Hospital

About this trial

Recently, mesenchymal stem cell (MSC) transplantation has emerged as a promising treatment for liver cirrhosis in adults. Additionally, bone marrow-derived stem cell transplantation has shown success in treating children with biliary atresia (BA). This study aims to evaluate the efficacy of Umbilical Cord-Derived Mesenchymal Stem Cell (UC-MSC) therapy in BA through a multicentric randomized controlled trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Infants were diagnosed with liver cirrhosis due to biliary atresia following Kasai's operation.

The patients two months old or older and exhibited signs of cirrhosis after the procedure, including hepatomegaly, congestive splenomegaly, elevated liver enzymes, esophageal varices (confirmed by endoscopy), and cirrhosis (confirmed by liver biopsy).

Disqualifiers

Epilepsy

Neurological disorders

Coagulation disorders

Diabetes

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stem Cell

    Drug

    UC-MSC transplantation will be administered twice to each patient in the study group via the hepatic artery: the first transplantation will be performed post-surgery at the beginning, and the second one will be performed 6 months later, with a dose of 1 million UC-MSC/kg.

  • Control

    Other intervention

    In this group, UC-MSC will not be administered. This group serves as a passive control. The standard treatments that are routinely provided to these patients will continue to be administered.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Stem Cell Application GroupExperimental treatment 1 intervention
Group B: ControlSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events

Adverse events will be assessed during the stem cell applications, as well as at 1 week, 1 month, 3 months, 6 months, 1 year, and 2 years after the application.

Time frame
2 years

Secondary outcomes

1

Pediatric End-Stage Liver Disease (PELD) score

Using PELD score (according to the suggestion of The Liver and Intestinal Organ Transplantation Committee in 2009). PELD is calculated based on three indicators: albumin (g / dL), bilirubin (units: mg / dL) and INR (international normalized ratio). Formula: PELD = 10 \* (0.48 \* ln(Serum Bilirubin) + 1.857 \* ln(INR) - 0.687 \* ln(Albumin) + (0.436 if patient is less than 1 year old) + (0.667 if patient has growth failure)). Evaluate the result: If PELD \<10: good results If 10 \<PELD \<15: average results If PELD\> 15: bad results Albumin (Unit: g / dL), bilirubin (units: mg / dL) and INR (international normalized ratio).

Time frame
2 years
2

ALT levels (Alanine transaminase)

The levels of ALT will be closely monitored in both groups. The values for this parameter will be recorded and evaluated individually for each patient.

Time frame
2 years
3

AST levels (Aspartate trasnaminase)

The levels of AST will be closely monitored in both groups. The values for each parameter will be recorded and evaluated individually for each patient.

Time frame
2 years
4

Direct bilirubin levels

The levels of direct bilirubin will be closely monitored in both groups. The values for each parameter will be recorded and evaluated individually for each patient.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Necmi Kadıoğlu Hospital

Lead sponsor

Source ClinicalTrials.gov
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