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Own stem cells may heal scarred vocal cords and restore voice

NCT ID NCT04290182

Disease control Sponsor: Karolinska University Hospital 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether injecting a patient's own stem cells into scarred vocal folds could safely improve severe hoarseness. Nine adults with untreatable voice problems received the stem cell injection during surgery. Researchers monitored side effects and voice function for one year to see if the treatment was safe and could help restore their voice.

What this could mean

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

Active substance
patient's own mesenchymal stromal cells (stem cells)
What this could lead to
If it works, this could offer a lasting treatment for severe hoarseness caused by vocal fold scarring, where no effective options exist today.
What could go wrong
This is a very early, small trial (9 people) with no control group, so results may not apply widely. The treatment is also surgical, with inherent risks.

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

9 people

The number who actually took part.

Started

Mar 2021

Finished

Jan 2025

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: * Patients between 18-65 years with VF scarring and severe voice problems, such as permanent severe hoarseness, complete aphonia or severe voice strain during speech (\>1 year) where other treatments have proven ineffective and no alternative treatment is possible. * No alternative treatment ongoing or planned (phonosurgery with augmentation implantation, voice therapy or other medical treatment). Exclusion Criteria: * Active treatment of laryngeal disorder, inflammatory condition of the larynx, or laryngeal/VF papilloma. * Diagnosed or suspicion of local malignancy or other malignancies, Disease-free period of \>5 years after malignant disease (\>10 years for local laryngeal cancer). * Smokers. * Large scar defects. * Pregnant or nursing (lactating) women. * Serological evidence of infection with HIV, HBV, HCV, HTLV and/or syphilis. * Active ongoing local or systemic infections. * Ongoing immune suppressive treatment.

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Conditions

The condition(s) this trial relates to.

Aphonia Hoarseness spasmodic dystonia

As listed by the trial registrant

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

Aphonia Dysphonia Hoarseness Vocal fold scar

Contacts and locations

Locations

  • Karolinska Trial Alliance

    Stockholm, Stockholm County, 11324, Sweden

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