Dysphonia Clinical Trial
Official title:
An Open Phase I/II Study in Patients With Dysphonia and Vocal Fold Scarring to Evaluate Safety, Tolerability and Vocal Function After Surgery With Local Administration of Autologous Mesenchymal Stromal Cells
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 present there is no lasting effective treatment for this condition which
results in personal suffering, and often extended sick leave, change of work or unemployement
for the patients.
Based on the previous results the investigators expect the autologous MSC product
KI-MSC-PL-204 to be a new effective treatment without side effects for many patients with
severe hoarseness or aphonia due to vocal fold scarring.
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 is early acquired (sulcus vocalis with scar) and results in stiff vocal folds
with decreased vibratory capacity and severe deterioration or total loss of voice (aphonia).
There is no lasting effective treatment. Bone marrow derived mesenchymal stem cells (MSC) are
immunomodulatory, decrease inflammation and improve endogenous healing. After receiving
ethical permission the investigators have since 2012 treated 16 patients with manifest vocal
fold scarring and severe hoarseness by scar resection and local injection of autologous bone
marrow MSC to restore speech. This project was the first in the world to study the effects of
MSC treatment of vocal fold scarring in humans. Analysis was made before and up to 12 months
post operatively with voice recordings, examination with high speed camera and elasticity
measurements of the vocal folds with novel technology. No side effects were found for any
patient and for two thirds of the patients with 12 months follow-up the vocal fold function
improved and no patient deteriorated.
While cell therapy with autologous MSC was classified according to the Tissue Legislation
before 2015, it is now regarded as drug treatment. In accordance with this legislation, the
MSC production is now full scale GMP. The investigators have recently received permissions
from Swedish Medical Product Agency (DNr 5.1-2019-92069) and from the Regional ethic
committee (Drn 2019-06160) for an open Phase I/Il study in patients with severe dysphonia and
vocal fold scarring to evaluate safety, tolerability and vocal function after surgery with
local administration of autologous mesenchymal stromal cell product KI-MSC-PL-204 as an
extended study on 15 patients.
MSC may in the future be used to treat patients with severe hoarseness due to scarring, as
well as other damages in the airways.
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