Vocal Cord Dysfunction
Conditions
Brief summary
This study is carried out to explore the short-term and long-term efficacy of the functional collagen scaffold in guiding laryngeal soft tissue regeneration.
Interventions
BIOLOGICALAutologous fat transplantation
Autologous abdominal fat will be injected into vocal cord beneath mucous under surgery microscope.
Injectable collagen scaffold combined with adipose derived stem cells that are isolated from abdominal adipose tissue will be injected into vocal cord beneath mucous under surgery microscope.
Sponsors
Peking Union Medical College
Chinese Academy of Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age of 18-65 years old, male or female 2. Severe unilateral vocal cord injury and poor closure of the glottis 3. Disease course was more than 1 year 4. At least two GRBAS scores reach 2 points or more 5. The subjects have read and fully understood the research notes, signed informed consent
Exclusion criteria
1. Over speaking professionals, such as teachers, shop assistants. 2. With vital organ dysfunction, such as heart, lung, liver or kidney. 3. Pregnant or lactating women, or in preconception period. 4. Allergic to various drugs. 5. Difficult to be followed-up or cooperate long-termly. 6. Participated in other clinical trials in the last 3 months. 7. With progressive severe disease. 8. Alcoholics or drug addicts. 9. Unable to execute clinical study protocol due to severe mental disorders or lingual barriers 10. With inevitable circumstances of voice damage. 11. Any other unsuitable conditions for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in subjective auditory perception score | 1 week, 2 week, 1,3,6,12 month after intervention |
Secondary
| Measure | Time frame |
|---|---|
| Objective acoustic evaluation (Jitter) | 1 week, 2 week, 1,3,6,12 month after intervention |
| Objective acoustic evaluation (Shimmer) | 1 week, 2 week, 1,3,6,12 month after intervention |
| Objective acoustic evaluation (Normalized noise energy) | 1 week, 2 week, 1,3,6,12 month after intervention |
| Objective acoustic evaluation（Maximum phonation time） | 1 week, 2 week, 1,3,6,12 month after intervention |
| Change in voice handicap index (VHI) scale | 1 week, 2 week, 1,3,6,12 month after intervention |
| Physical status assessment of vocal cords （Closing test of vocal cords） | 1 week, 2 week, 1,3,6,12 month after intervention |
| Physical status assessment of vocal cords （Morphology of vocal cords） | 1 week, 2 week, 1,3,6,12 month after intervention |
| Change in volume of vocal cords | 1 week, 2 week, 1,3,6,12 month after intervention |
| Physical status assessment of vocal cords（Motor test of vocal cords） | 1 week, 2 week, 1,3,6,12 month after intervention |
Countries
China
Outcome results
None listed