Phase 2
N=21
Controlled Study to Evaluate the Safety and Efficacy of Azficel-T for Vocal Fold Scarring and Age-Related Dysphonia
Dysphonia Resulting From Vocal Fold Scarring · Age-related Dysphonia
Bottom Line
View on ClinicalTrials.gov: NCT02120781 ↗Enrolled (actual)
21
Serious AEs
14.3%
Results posted
Jun 2021
Primary outcome: Primary: Number of Participants With Any Improvement From Baseline in Mucosal Wave Grade — 14; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Azficel-T (autologous fibroblasts) (Biological); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Castle Creek Biosciences, LLC.
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Improvement From Baseline in Mucosal Wave Grade |
14; 5 | — |
| PRIMARY Number of Participants With an Absolute Change in Voice Handicap Index Score (Decrease of 18 or More Points) From Baseline |
4; 3 | — |
| PRIMARY Mean Percentage Change From Baseline in Voice Handicap Index Score |
-10.00; -28.86 | — |
| PRIMARY Number of Participants With at Least One Level of Improvement in Perceptual Analysis of Dysphonia Using GRBAS Scale. |
4; 2 | — |
| PRIMARY Number of Participants With at Least One Level of Improvement in Perceptual Analysis of Roughness Using GRBAS Scale. |
1; 2 | — |
| PRIMARY Number of Participants With at Least One Level of Improvement in Perceptual Analysis of Breathiness Using GRBAS Scale. |
5; 0 | — |
| PRIMARY Number of Participants With at Least One Level of Improvement in Perceptual Analysis of Asthenia Using GRBAS Scale. |
4; 3 | — |
| PRIMARY Number of Participants With at Least One Level of Improvement in Perceptual Analysis of Strain Using GRBAS Scale. |
2; 1 | — |
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
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02120781). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.