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 × 10 6 MSCs/patient). Patients were monitored 1 year for serious adverse events (SAE) or minor complications. Therapeutic efficacy on treated VFs was evaluated by measurement of VF vibrations using high-speed laryngoscopy (HSL) and phonation pressure threshold (PTP) for elasticity and VF function. Patients self-reported voice change using the Voice Handicap Index (VHI). Results: No SAE or minor side effects were reported. Video ratings of VF vibrations and digitized analysis of HSL and PTP were significantly improved for 62-75% of the patients (depending on parameter). Two patients showed deteriorated VF vibrations, but improved PTP. VHI was significantly improved in 8 patients, with the remaining experiencing no significant change. Conclusions: The results indicate that local injection of autologous MSC into scarred VFs with severe voice problems may offer a safe and feasible therapeutic option. VF vibration and elasticity were improved in approximately two thirds of treated patients. This clinical study is registered in clinicaltrials.gov (ID: NCT01981330). Retrospective registration of first patient (20130511). https//: register.clinicaltrials.gov/.
Objective: Vocal fold scarring (VFS) and sulcus vocalis (SV) often result in severe and chronic voice disorders. This study compares subjective voice complaints as rated with the Voice Handicap Index and etiological factors for patients with VFS and SV. Patients and Methods: Data were collected from the medical records at the Department of Otorhinolaryngology, Karolinska University Hospital, for 27 VFS patients and 27 SV patients. Descriptive background factors were compared between the groups and data were compared from the Swedish Voice Handicap Index (Sw-VHI) questionnaires. Results: Previous laryngeal surgery/trauma was significantly more common for the patients with VFS. The SV group had significantly more persistent dysphonia since childhood. It was significantly more common to have a non-Germanic language origin among the SV patients. VFS and SV rated high for the total median Sw-VHI scores. The VFS group’s total Sw-VHI and the three domain scores were significantly higher compared to the SV group. The physical domain showed a significantly higher score when compared to the functional and emotional domains in the SV cohort and when compared to the emotional domain in the VFS cohort. Conclusion: There are significant differences between the VFS group and SV group regarding etiological factors as well as the Sw-VHI. The degree and profile of VHI should be considered when selecting patients and evaluating the result of new treatments for this group of patients.
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