CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 9 enrolled
Drug / intervention
MSC-KI-PL-204biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04290182
NCT04290182Phase 2Completed
CompareCT.gov

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

Karolinska University Hospital·interventional·Posted Feb 28, 2020·Updated Jan 27, 2026

In Brief

A Phase 2 clinical trial evaluating MSC-KI-PL-204 for Hoarseness and 3 related conditions. Completed, enrolled 9 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHoarseness, Dysphonia, Aphonia, Vocal Fold Scar
CountriesSweden
CollaboratorsSwedish Foundation for Strategic Research

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedFeb 28, 2020
Enrollment StartMar 1, 2021
Primary CompletionJan 1, 2025
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 6.3 years ago

Interventions

MSC-KI-PL-204biological

Autologous MSC product