Clinical Study of Regeneration on Larynx Soft Tissue Guided by Functional Collagen Scaffold

Phase 1

Completed

• Conditions: Vocal Cord Dysfunction
• Interventions: Biological: Functional collagen scaffold transplantation; Biological: Autologous fat transplantation

• Registration Number: NCT02754284
• Lead Sponsor: Chinese Academy of Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Status Verified: 2016-04
• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-25
• Study First Posted: 2016-04-28
• Primary Completion: 2020-06
• Study Completion: 2020-06
• Last Update Submitted: 2020-12-31
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Functional collagen scaffold transplantation	Functional collagen scaffold transplantation	-
Autologous fat transplantation	Autologous fat transplantation	-

Primary Outcome Measures

Name	Time	Method
Change in subjective auditory perception score	1 week, 2 week, 1,3,6,12 month after intervention

Secondary Outcome Measures

Name	Time	Method
Change in voice handicap index (VHI) scale	1 week, 2 week, 1,3,6,12 month after intervention
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
Physical status assessment of vocal cords（Motor test of vocal cords）	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

Trial Locations

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China