Pilot Study of Stem Cell Treatment of Patients With Vocal Fold Scarring

Study Overview
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Brief Summary
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This is a pilot-study of 16 selected Swedish patients which all have severe hoarseness or aphonia due to vocal fold scarring (from previous surgery, radiation therapy, inflammation or possibly hereditary). The patients are operated with phonomicrosurgical dissection of the scarred vocal folds, removal or scar tissue and injection of autologous mesenchymal stroma cells, aMSC (which were previously harvested from each patients´s bone marrow, purified, expanded and characterized according to standard procedure at the Center of Hematology and Regenerative Medicine Karolinska University Hospital Huddinge). 8 Patients is planned to be treated with a single injection of aMSC and 8 patients with injection of aMSC mixed with a carrier hyaluronan gel developed at Uppsala University Sweden and at the Karolinska Institute. The laryngeal status, vocal fold function, and voice function will be followed individually with an advanced battery of examinations performed before and up to 1 year postoperatively. Side effects and complications are noted and reported during surgery and following surgery at regular intervals during at least 1 year Since spring 2015 no new patients have been recruited and no treatments are given during 2016 or 2017. The monitoring authority was changed from Swedish National Board of Health to Swedish Medical Product Agency (MPA) in March/April 2016. Further inclusions and treatments are postponed until permission is granted from MPA to continue the study.

Official Title
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Pilot Study of Patients With Severe Hoarseness and Vocal Fold Scarring Treated With Mesenchymal Stem Cells With and Without Hyaluronan Gel

Conditions
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Improved Healing of Scarred Vocal Folds, Improved Vocal Fold Status, Improved Vocal Fold Function

Intervention / Treatment
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* Biological: aMSC
* Biological: aMSC+hyaluronan gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: severe hoarseness vocal fold scarring no active other treatment age above 18 years Exclusion Criteria: active treatment of laryngeal disorder active inflammatory condition of the larynx diagnosed or suspicions of local malignancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aMSC with and without hyaluronan gel<br>autologous mesenchymal stem cells (aMSC) injected into the vocal folds in 8 patients and aMSC mixed with hyaluronan gel in 8 patients | Biological: aMSC<br>* aMSC injected into the vocal fold of the patient<br>Biological: aMSC+hyaluronan gel<br>* aMSC+ hyaluronan gel is injected into the patients vocal fold<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved healing of scarred vocal folds | Laryngeal and general ear, nose, and throat status will be followed for each patient at least one year after primary treatment. This includes examination of signs of local (laryngeal) inflammatory reaction/defect healing, e.g. polyp or granuloma formation, inflammatory reaction after local aMSC injection It also includes repetitive examinations of vocal fold function and voice function including high speed examination of the vocal folds, acoustic voice analysis and phonation pressure measurements as well as subjective ratings by means of Voice handicap index scale | 1 year postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vocal fold scarring, mesenchymal stem cells