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

Karolinska University Hospital

Status and phase: Completed; Phase 1

Conditions: Improved Vocal Fold Status; Improved Vocal Fold Function; Improved Healing of Scarred Vocal Folds

Treatments: Biological: aMSC; Biological: aMSC+hyaluronan gel

Study type: Interventional

Funder types: Other

Identifiers

NCT01981330

2010/1650 and 2014-51432

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

aMSC with and without hyaluronan gel

Experimental group

Description:

autologous mesenchymal stem cells (aMSC) injected into the vocal folds in 8 patients and aMSC mixed with hyaluronan gel in 8 patients

Treatment:

Biological: aMSC+hyaluronan gel

Biological: aMSC