Clinical trial NCT02754284: Clinical Study of Regeneration on Larynx Soft Tissue Guided by Functional Collagen Scaffold
Official title: The Safety and Efficacy Assessment of Functional Collagen Scaffold Transplantation for Larynx Soft Tissue Regeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Vocal Cord Dysfunction
Lead sponsor: Chinese Academy of Sciences
Sponsor class: OTHER_GOV
Collaborators: name: Peking Union Medical College
First posted: 2016-04-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in subjective auditory perception score
timeFrame: 1 week, 2 week, 1,3,6,12 month after intervention
Secondary outcomes:
measure: Change in voice handicap index (VHI) scale
timeFrame: 1 week, 2 week, 1,3,6,12 month after intervention
measure: Objective acoustic evaluation (Jitter)
timeFrame: 1 week, 2 week, 1,3,6,12 month after intervention
measure: Objective acoustic evaluation (Shimmer)
timeFrame: 1 week, 2 week, 1,3,6,12 month after intervention
measure: Objective acoustic evaluation (Normalized noise energy)
timeFrame: 1 week, 2 week, 1,3,6,12 month after intervention
measure: Objective acoustic evaluation（Maximum phonation time）
timeFrame: 1 week, 2 week, 1,3,6,12 month after intervention
measure: Physical status assessment of vocal cords（Motor test of vocal cords）
timeFrame: 1 week, 2 week, 1,3,6,12 month after intervention
measure: Physical status assessment of vocal cords （Closing test of vocal cords）
timeFrame: 1 week, 2 week, 1,3,6,12 month after intervention
measure: Physical status assessment of vocal cords （Morphology of vocal cords）
timeFrame: 1 week, 2 week, 1,3,6,12 month after intervention
measure: Change in volume of vocal cords
timeFrame: 1 week, 2 week, 1,3,6,12 month after intervention
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: Chinese Academy of Sciences
name: Jianwu Dai, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: