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Could stem cell particles restore hearing? new trial begins.

NCT ID NCT07404709

Disease control Sponsor: The Affiliated Hospital of Qingdao 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests whether tiny particles from stem cells can help treat severe sudden hearing loss. Nine adults will receive injections into the ear alongside standard care. The study checks for safety and whether hearing improves compared to a common steroid treatment.

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 9 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

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

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: 1. Sudden unilateral hearing loss that occurs within 72 hours, with a decrease of at least 30 decibels in at least 3 frequency ranges compared to the healthy ear, and an average pure tone threshold of ≥ 65 decibels. 2. Enrollment must be completed within 7 days after the onset of sudden deafness. 3. Men or women aged 18 to 65 4. Not treated in any other hospital and not taking any treatment medication on one's own 5. Be able to understand the trial protocol and undergo regular follow-up visits and check-ups Exclusion Criteria: 1. Pregnant or lactating women 2. With a history of chronic ear diseases, ear surgery, autoimmune hearing loss or a confirmed diagnosis of Meniere's syndrome in the past 3. Having received steroid treatment for any reason within the past 30 days 4. There are autoimmune diseases or chronic inflammatory diseases. 5. Severe damage to liver and kidney functions 6. Patients with a previous history of cerebral hemorrhage or those currently taking anticoagulant medications 7. Other cases in which the researchers judged the candidates to be unsuitable for inclusion

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Conditions

The condition(s) this trial relates to.

sudden sensorineural hearing loss

As listed by the trial registrant

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

Extracellular vesicles Sudden hearing loss

How to take part

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

  1. The places running it

    5 sites. 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

  • Chongqing General Hospital

    Chongqing, Sichuan, 401121, China

  • Guangdong General Hospital

    Guangzhou, Guangdong, 519041, China

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266100, China

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510080, China

  • he Second Affiliated Hospital of Shandong First Medical University

    Tai’an, Shandong, 271000, China

More trials for these conditions

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