drugset / Trial / NCT04290182

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

NCT04290182 ↗

NaSingle-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject MSC-KI-PL-204 Cell therapy 500000 cells Other
Subject MSC-KI-PL-204 Cell therapy 1e+06 cells Other
Subject MSC-KI-PL-204 Cell therapy 2e+06 cells Other