CompletedPhase 1/2

A Study of Local Administration of Autologous Mesenchymal Stromal Cells in Dysphonic Patients With Vocal Fold Scarring

Sweden9 participantsStarted 2021-03-01

Plain-language summary

The overall aim of the project is to develop a new method for treatment of untreatable severe hoarseness due to vocal fold scarring by local injection of autologous mesenchymal stromal cells (MSC). At present there is no lasting effective treatment for this condition which results in personal suffering, and often extended sick leave, change of work or unemployement for the patients. Based on the previous results the investigators expect the autologous MSC product KI-MSC-PL-204 to be a new effective treatment without side effects for many patients with severe hoarseness or aphonia due to vocal fold scarring.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety and tolerability of treatment

Timeframe: 3 year

Trial details

NCT IDNCT04290182

SponsorKarolinska University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-01

View on ClinicalTrials.gov More Hoarseness trials