Clinical Trials Directory

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.

Investigator(s):

Intervention(s):

  • biological : Azficel-T (autologous fibroblasts)
  • drug : Placebo

Phase: Phase 2

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

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

External Links

Contact information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Edward J Damrose, MD
650-725-6500
Recruiting

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