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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02120781
• Date of registration: 21/03/2014
• Prospective Registration: No
• Primary sponsor: Fibrocell Technologies, Inc.
• Public title: Controlled Study to Evaluate the Safety and Efficacy of Azficel-T for the Treatment of Vocal Fold Scarring and Age-Related Dysphonia
• Scientific title: 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
• Date of first enrolment: March 2014
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02120781
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Dinesh Chhetri, MD
• Affiliation: University of California, Los Angeles

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Dysphonia Resulting From Vocal Fold Scarring

Age-related Dysphonia

Intervention(s)

Drug: Placebo

Biological: Azficel-T (autologous fibroblasts)

Primary Outcome(s)

Voice Handicap Index Score [Time Frame: Four months after final treatment]

Videostroboscopy [Time Frame: Four months after final treatment]

Perceptual analysis using GRBAS scale [Time Frame: Four months after final treatment]

Secondary Outcome(s)

Change from baseline in auditory-perceptual ratings [Time Frame: Four months after final treatment]

Improvement in voice quality on visual analog scale [Time Frame: Four months after final treament]

Change from baseline in shimmer [Time Frame: Four months after final treatment]

Improvement in voice quality using questionnaire [Time Frame: Four months after final treatment]

Change from baseline in percentage jitter [Time Frame: Four months after final treatment]

Proportion of subjects with "Normal" fundamental frequency [Time Frame: Four months after final treatment]

Change from baseline in maximum phonation time [Time Frame: Four months after final treatment]

Change from baseline in the noise-to-harmonic ratio [Time Frame: Four months from final treatment]

Secondary ID(s)

FI-V-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors