A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Azficel-T for the Treatment of Vocal Fold Scarring and Age-Related Dysphonia
The objectives of this study are to assess the safety of azficel-T treatment for dysphonia related to vocal fold function and to evaluate the efficacy of azficel-T for the treatment of dysphonia related to vocal fold function.
Stanford is now accepting new patients for this trial.
- biological : Azficel-T (autologous fibroblasts)
- drug : Placebo
Phase: Phase 2
Ages Eligible For Study:
1. Subject has read and signed the Institutional Review Board (IRB)-approved informed consent form (ICF) before treatment 2. Subject is at least 18 years of age 3. Subject has presence of unilateral or bilateral vocal fold scarring or age-related dysphonia, as diagnosed by medical history and physical examination 4. Subject must have Grade 1-2 mucosal waves as determined by videostroboscopy 5. Subject has failed any one or more of the following treatments including, but not limited to, anti-reflux regimen, speech therapy, or vocal fold injection augmentation prior to screening 6. Subject feels that their voice quality is a major handicap 7. Subject must have a blood sample tested and found to be non-reactive for human immunodeficiency virus-1 (HIV-1) antibody, hepatitis B surface antigen and hepatitis C virus (HCV) antibody 8. If the subject is female and of childbearing potential, she must agree to use a medically acceptable means of birth control, and test negative on a urine pregnancy test 9. Subject must be willing and able to follow study procedures and instructions