INNOVATIVE TREATMENT OF SCARRED VOCAL FOLDS BY LOCAL INJECTION OF AUTOLOGOUS ADIPOSE-DERIVED STROMAL VASCULAR FRACTION: EFFICACY VERSUS PLACEBO

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517384-24-00

Acronym

cellcordes2

Enrollment

Registered

2024-09-30

Start date

2022-09-22

Completion date

Unknown

Last updated

2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SCARRED VOCAL FOLDS

Brief summary

Changes from baseline in Self-evaluation with the Voice Handicap Index (VHI), a shift in the total score of 18 points or greater being required to be clinically significant (Jacobson, 1997)

Detailed description

VHI at 1 month, self-evaluation of dysphonia (0-10 scale), voice acoustic measurements, voice aerodynamic measurements: maximum phonation time, perceptive analysis (GRB scale): score will be calculated by addition of two characteristics, videolaryngostroboscopy, The incidence of related Adverse Events

Interventions

DRUGPlacebo SVF inj prep

DRUGthawed SVF 5 inj prep

DRUGSVF 5 inj prep

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Changes from baseline in Self-evaluation with the Voice Handicap Index (VHI), a shift in the total score of 18 points or greater being required to be clinically significant (Jacobson, 1997)	—

Secondary

Measure	Time frame
VHI at 1 month, self-evaluation of dysphonia (0-10 scale), voice acoustic measurements, voice aerodynamic measurements: maximum phonation time, perceptive analysis (GRB scale): score will be calculated by addition of two characteristics, videolaryngostroboscopy, The incidence of related Adverse Events	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026