This trial is active, not recruiting.

Conditions improved healing of scarred vocal folds, improved vocal fold status, improved vocal fold function
Treatments amsc, amsc+hyaluronan gel
Phase phase 1
Sponsor Karolinska University Hospital
Collaborator The Swedish Research Council
Start date January 2012
End date June 2017
Trial size 25 participants
Trial identifier NCT01981330, 2010/1650 and 2014-51432


This is a pilot-study of 25 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). 14 Patients is planned to be treated with a single injection of aMSC and 11 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 autumn 2015 no new patients have been recruited and no treatments are given during 2016. 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
autologous mesenchymal stem cells (aMSC) injected into the vocal folds in 14 patients and aMSC mixed with hyaluronan gel in 11 patients
aMSC injected into the vocal fold of the patient
amsc+hyaluronan gel
aMSC+ hyaluronan gel is injected into the patients vocal fold

Primary Outcomes

Improved healing of scarred vocal folds
time frame: 1 year postoperatively

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Pilot Study of Patients With Severe Hoarseness and Vocal Fold Scarring Treated With Mesenchymal Stem Cells With and Without Hyaluronan Gel
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Karolinska University Hospital.