Treatment of vocal fold scarring with autologous bone marrow-derived human mesenchymal stromal cells-first phase I/II human clinical study.

ABSTRACT:

Background

Vocal fold (VF) scarring, caused by surgery or inflammation, often results in severe voice problems or aphonia. Effective lasting treatment is lacking. Previous in vitro and in vivo animal studies reported positive effects on VF scar resolution with mesenchymal stromal cell (MSC) implantation. The principal aim of this study was to examine safety aspects and secondly treatment efficacy vocal fold function in patients with VF scarring and severe voice problems.

Methods

In this open-label phase I/II study, 16 patients were treated with surgical scar resection followed by injection of autologous MSCs (0.5-2 × 10⁶ MSCs/patient). Patients were monitored 1 year for serious adverse events (SAE) or minor complications. Therapeutic efficacy on treated VFs was ev

SUBMITTER: Hertegard S 

PROVIDER: S-EPMC7083053 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature