NCT04290182

A Study of Local Administration of Autologous Mesenchymal Stromal Cells in Dysphonic Patients With Vocal Fold Scarring

Completed Phase 1, PHASE2 Last updated 27 January 2026

What this trial tests

Phase 1, PHASE2 trial testing MSC-KI-PL-204 in Hoarseness in 9 participants. Completed in 1 January 2025.

Timeline

1 March 2021

Primary endpoint
1 January 2025

1 January 2025

Quick facts

Lead sponsor	Karolinska University Hospital
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	1 March 2021
Primary completion	1 January 2025
Estimated completion	1 January 2025
Sites	1 location across Sweden

Drugs / interventions tested

• MSC-KI-PL-204 — full drug profile →

Conditions studied

• Hoarseness — all drugs for Hoarseness →
• Dysphonia — all drugs for Dysphonia →
• Aphonia — all drugs for Aphonia →
• Vocal Fold Scar — all drugs for Vocal Fold Scar →

Sponsor

Karolinska University Hospital

Who can join

Adults 18 to 65, any sex, with Hoarseness or Dysphonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Clinical Trials of Mesenchymal Stromal Cells Therapy.
   Kouchakian MR, Baghban N, Moniri SF, Baghban M, et al · · 2021 · cited 30× · PMID 34745268 · DOI 10.1155/2021/1634782
2. Regenerative medicine approaches for the management of respiratory tract fistulas.
   Trivisonno A, Nachira D, Boškoski I, Porziella V, et al · · 2020 · cited 14× · PMID 33097096 · DOI 10.1186/s13287-020-01968-1
3. Promising role for mesenchymal stromal cells in coronavirus infectious disease-19 (COVID-19)-related severe acute respiratory syndrome?
   Hamdan H, Hashmi SK, Lazarus H, Gale RP, et al · · 2021 · cited 11× · PMID 32854985 · DOI 10.1016/j.blre.2020.100742
4. Genipin cross-linked gelatin hydrogel for encapsulating wharton jelly mesenchymal stem cells and basic fibroblast growth factor delivery in vocal fold regeneration.
   Wan-Chiew N, Baki MM, Lokanathan Y, Fauzi MB, et al · · 2024 · cited 6× · PMID 39703693 · DOI 10.3389/fcell.2024.1489901
5. Tissue Engineering as a Promising Treatment for Glottic Insufficiency: A Review on Biomolecules and Cell-Laden Hydrogel.
   Ng WC, Lokanathan Y, Baki MM, Fauzi MB, et al · · 2022 · cited 3× · PMID 36551838 · DOI 10.3390/biomedicines10123082
6. An open phase I/IIa study evaluating safety, patient-reported outcomes and voice function after surgery, local administration of mesenchymal stromal cells and voice training in patients with vocal fold scarring and dysphonia.
   Bergström Börlin E, Nygren U, Södersten M, Granqvist S, et al · · 2026 · PMID 42002761 · DOI 10.1186/s13287-026-05022-4