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

Completed · Phase 2 · Has a placebo group

Conditions studied: Dysphonia Resulting From Vocal Fold Scarring, Age-related Dysphonia

In brief

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.

Key facts

Study ID

NCT02120781

Run by

Castle Creek Biosciences, LLC.

People needed

21

Starts

2014-03-01

Expected to finish

2016-12-21

Last updated by the study team

2021-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has read and signed the Institutional Review Board (IRB)-approved informed consent form (ICF) before treatment
• Subject is at least 18 years of age
• Subject has presence of unilateral or bilateral vocal fold scarring or age-related dysphonia, as diagnosed by medical history and physical examination
• Subject must have Grade 1-2 mucosal waves as determined by videostroboscopy
• 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
• Subject feels that their voice quality is a major handicap
• 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
• 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
• Subject must be willing and able to follow study procedures and instructions

You may not qualify if…

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

Where it is running

• Surgery/Head and Neck, David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• Dept of Otolaryngology, Stanford Univ Medical Center — Stanford, California, United States
• NYU Langone Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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