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Stem cell injection aims to prevent deadly liver complication

NCT ID NCT07276568

Disease control Sponsor: Zhi-Jun Zhu 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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-phase trial tests whether injecting special liver-like cells into the abdominal muscle can help prevent or treat Small-for-Size syndrome, a serious complication that can occur after partial liver surgery. The study involves 12 patients and focuses mainly on safety, checking for side effects and changes in liver function. If the approach proves safe, it may pave the way for larger studies to see if it truly improves outcomes.

What this could mean

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

Active substance
Hepatocyte-like cells (derived from induced pluripotent stem cells)
What this could lead to
If successful, this could lead to a new way to prevent or treat Small-for-Size syndrome, a serious complication after liver surgery, potentially improving survival.
What could go wrong
This is a very early (Phase 1) trial with only 12 participants, so safety and effectiveness are not yet proven. There is a risk of injection-related side effects or the cells not working as hoped.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 12 people

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

Started

Dec 2025

Expected to finish

Dec 2029

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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 must be diagnosed with liver failure or small-for-size syndrome based on clinical presentation. （Acute Liver Failure (ALF) An acute onset of liver failure characterized by hepatic encephalopathy of grade II or higher within 4 weeks, in a patient without pre-existing liver disease. Acute-on-Chronic Liver Failure (ACLF) A complex clinical syndrome characterized by acute deterioration of liver function, triggered by precipitating events, in patients with underlying chronic liver disease (with or without cirrhosis). It manifests as single or multiple organ failure(s) and is associated with high short-term mortality (28-day mortality rate ≥ 15%). Chronic Liver Failure (CLF) A state of chronic hepatic decompensation occurring progressively in patients with cirrhosis. It is primarily characterized by recurrent ascites and/or hepatic encephalopathy resulting from progressively declining liver function. Small-for-Size Syndrome (SFSS) Diagnosis is established according to the International Liver Transplantation Society (ILTS) 2023 guidelines on SFSS.） ② Patients must agree to undergo intramuscular injection of cells into the rectus sheath. Exclusion Criteria: \- Subjects meeting any of the following criteria will be excluded from the study: 1. Presence of severe, life-threatening extrahepatic systemic diseases. 2. Uncontrolled active infection or hemorrhage. 3. Pregnancy or lactation in female patients. 4. History of severe allergic reactions or known hypersensitivity to CiPS-derived cell products or blood products. 5. Inability to undergo phlebotomy due to peripheral vascular collapse. 6. Inability or unwillingness to provide informed consent or comply with the study procedures. 7. Unwillingness to receive CiPS-based therapy.

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Conditions

The condition(s) this trial relates to.

acute liver failure chronic liver failure liver failure

As listed by the trial registrant

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

Acute liver failure Acute on chronic liver failure (ACLF) Chronic liver failure Small-for-size syndrome

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

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Province, 100050, China

More trials for these conditions

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