Status:
UNKNOWN
A Study of Local Administration of Autologous Mesenchymal Stromal Cells in Dysphonic Patients With Vocal Fold Scarring
Lead Sponsor:
Karolinska University Hospital
Collaborating Sponsors:
Swedish Foundation for Strategic Research
Conditions:
Hoarseness
Dysphonia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
The general aim of the project is to develop a treatment for severe hoarseness due to vocal fold (VF) scarring. Vocal fold scarring can be caused by tumor surgery, radiotherapy, severe inflammation or...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04290182
Start Date
March 1 2020
End Date
June 1 2023
Last Update
February 28 2020
Active Locations (1)
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1
Karolinska Trial Alliance
Stockholm, Sweden, 11324