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

NCT04290182 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-01-27

No results posted yet for this study

Summary

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.

Conditions

  • Hoarseness
  • Dysphonia
  • Aphonia
  • Vocal Fold Scar

Interventions

BIOLOGICAL

MSC-KI-PL-204

Autologous MSC product

Sponsors & Collaborators

  • Swedish Foundation for Strategic Research

    collaborator OTHER

  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • Patric Scicluna, Clin Research Manager · Karolinska Trial Alliance

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2025-01-01
Completion
2025-01-01

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04290182 on ClinicalTrials.gov