Improved Healing of Scarred Vocal Folds, Improved Vocal Fold Function, Improved Vocal Fold Status
Conditions
Keywords
vocal fold scarring, mesenchymal stem cells
Brief summary
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.
Interventions
BIOLOGICALaMSC
aMSC injected into the vocal fold of the patient
BIOLOGICALaMSC+hyaluronan gel
aMSC+ hyaluronan gel is injected into the patients vocal fold
Sponsors
The Swedish Research Council
Laryngfonden
Karolinska Institutet
Karolinska University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improved healing of scarred vocal folds | 1 year postoperatively | 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 |
Countries
Sweden
Outcome results
None listed