Controlled Study to Evaluate the Safety and Efficacy of Azficel-T for Vocal Fold Scarring and Age-Related Dysphonia

• Status: Completed
• Trial end date: 2016-12-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Castle Creek Biosciences, LLC.; Fibrocell Technologies, Inc.

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