Trial Search Results

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 currently accepting patients for this trial.

Lead Sponsor:

Fibrocell Technologies, Inc.

Stanford Investigator(s):

Intervention(s):

  • Biological: Azficel-T (autologous fibroblasts)
  • Drug: Placebo

Phase:

Phase 2

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

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