Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can stem cells help infants with biliary atresia avoid a liver transplant?

NCT ID NCT07797673

Disease control Sponsor: Dr Cipto Mangunkusumo General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This trial tests whether injecting umbilical cord stem cells directly into the liver during Kasai surgery can improve outcomes for infants with biliary atresia, a condition where bile ducts are blocked and the liver becomes damaged. Forty infants aged 30 to 90 days will receive either the stem cell injection or a placebo during the procedure. Researchers will follow them for 180 days to check safety, liver function, and liver stiffness. The goal is to see if this added treatment can reduce the need for a future liver transplant.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Umbilical cord-derived mesenchymal stem cells injected directly into the liver during Kasai surgery
What this could lead to
If it works, this could offer a way to delay or avoid liver transplantation in infants with biliary atresia, improving long-term outcomes without lifelong immunosuppression.
What could go wrong
This is an early-phase trial with only 40 infants, so the stem cell injections may not improve liver function or may cause unexpected side effects. Success in this small group may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 90 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Pediatric patients aged 30 to 90 days. * Suspected biliary atresia based on clinical evaluation and diagnostic workup. * Biliary atresia diagnosis confirmed by intraoperative cholangiography. * Undergoing Kasai portoenterostomy at Cipto Mangunkusumo Hospital. * Written informed consent provided by a parent or legally authorized representative. Exclusion Criteria: * Presence of congenital heart disease. * Diagnosis of Down syndrome. * Diagnoses other than biliary atresia confirmed by intraoperative cholangiography (e.g., choledochal cyst) Drop-out Criteria: \- Subjects will be dropped from the study if they develop postoperative anastomotic leakage

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Biliary atresia are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

biliary atresia cirrhosis of liver fibrotic liver disease Hepatic Insufficiency liver failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Biliary atresia Kasai operation Liver fibrosis Liver function failure Stem cell

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cipto Mangunkusumo Hospital

    RECRUITING

    Jakarta Pusat, DKI Jakarta, 10430, Indonesia

More trials for these conditions

Other studies related to the condition(s) this trial covers.