Controlled Study to Evaluate the Safety and Efficacy of Azficel-T for Vocal Fold Scarring and Age-Related Dysphonia
Condition: Dysphonia Resulting From Vocal Fold Scarring; Age-related Dysphonia
MeSH terms: Dysphonia; Hoarseness; Cicatrix
Intervention: Azficel-T (autologous fibroblasts); Placebo
Intervention description: Autologous fibroblasts will be cultured from three 3-mm post auricular punch biopsies. Biopsies will be shipped from the clinical sites to the Fibrocell manufacturing site where the cells will be harvested, tested for sterility, endotoxin level, cell identity, viability and concentration. When the desired cell number is reached, cells will be transported to the investigative site as a suspension in shipping media.
Depending upon the clinical circumstances for each subject, the vocal fold(s) will be injected transorally or percutaneously in order to deposit 1.0 mL of study drug into the lamina propria layer of each vocal fold. The injection process will be visualized via a flexible fiberoptic laryngoscope inserted through the nostril.; Subjects randomized to placebo will receive injections of sterile saline into the vocal fold(s).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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

        Exclusion Criteria:

          1. Subject is pregnant or lactating

          2. Subject is a smoker

          3. Subject has an upper respiratory infection at baseline (subject can be rescheduled
             after four weeks)

          4. Subject is already participating, or has participated in another clinical trial
             involving therapeutic intervention within 30 days prior to enrollment

          5. Subject plans to begin or continue other vocal fold therapies during the course of
             this study

          6. Subject has other concurrent laryngeal pathology including lesions that would require
             removal