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Can stem cells repair a scarred liver? new trial hopes so

NCT ID NCT04357600

Disease control Sponsor: PT. Prodia Stem Cell Indonesia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial is testing whether stem cells from donated umbilical cords can help people with liver cirrhosis caused by hepatitis B. The study will give 12 patients an intravenous infusion of these stem cells and monitor their liver function, Child-Pugh score, and MELD score over six months. The goal is to see if the treatment can improve liver health and reduce the severity of cirrhosis.

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 stem cells
What this could lead to
If it works, this could point toward a new way to manage liver cirrhosis caused by hepatitis B, potentially reducing the need for a liver transplant.
What could go wrong
This is a very small, early-phase trial with only 12 participants. It is not yet proven to work, and there may be unknown risks from the stem cell infusion.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 12 people

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

Started

May 2018

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 65 years

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: * Patients with decompensated cirrhosis (Child-Pugh B) caused by hepatitis B infection (Cirrhosis is evidenced by the results of ultrasonography examination and chronic hepatitis B infection is found in patients who are taking hepatitis B drugs) Exclusion Criteria: * Patients who refuse to participate in research * Having malignancies disease, both liver malignancies or other malignancies * Having another co-infections such as hepatitis C and Human Immunodeficiency Virus (HIV). * Pregnant or lactation patients as evidenced by positive pregnancy test results * Having complications disease such as diabetes mellitus, severe heart disease, kidney disease, and respiratory disease * Having the case of alcohol dependence and NASH * Patients who have undergone transplantation and other stem cell therapy

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver

As listed by the trial registrant

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

Liver cirrhoses

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

    Jakarta, DKI Jakarta, Indonesia

More trials for these conditions

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