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Exosome therapy shows promise for liver crisis in small trial

NCT ID NCT07409259

Disease control Sponsor: Third Affiliated Hospital, Sun Yat-Sen University 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether exosomes (tiny particles from stem cells) can help people with sudden severe liver failure. Twenty adults will receive either standard care alone or standard care plus four doses of exosomes over 10 days. The main goal is to check safety and see if the treatment improves survival at 12 weeks.

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 20 people

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

Started

Jan 2026

Expected to finish

Aug 2027

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

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: * Aged 18 to 65 years, regardless of gender. * Diagnosed with Acute-on-Chronic Liver Failure (ACLF) according to the diagnostic criteria in the "Guidelines for Diagnosis and Treatment of Liver Failure (2024 Edition)." * COSSH-ACLF II score \< 7.4. * Participants must be fully informed about the study and voluntarily sign a written informed consent form prior to participation. Exclusion Criteria: * Patients with chronic liver failure. * Patients with active bleeding or Disseminated Intravascular Coagulation (DIC) that has not been effectively controlled. * Known allergy to blood products or any medications/drugs used in the treatment protocol. * Patients with circulatory failure. * History of myocardial infarction, cerebral infarction, or cerebral hemorrhage within the past 6 months. * History of malignancy within the past 5 years (excluding cured basal cell carcinoma of the skin or carcinoma in situ of the cervix). * Pregnant or lactating women. * Any other conditions that, in the opinion of the investigator, make the patient unsuitable for participation in the trial.

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Conditions

The condition(s) this trial relates to.

Acute-On-Chronic Liver Failure

As listed by the trial registrant

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

Acute on chronic liver failure (ACLF)

Contacts and locations

Locations

  • Third Affiliated Hospital, Sun Yat-sen University Guangzhou, Guangdong, China 510630

    Guangzhou, Guangdong, 510630, China

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