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

Study Overview
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Brief Summary
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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.

Official Title
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The Safety and Efficacy Assessment of Functional Collagen Scaffold Transplantation for Larynx Soft Tissue Regeneration

Conditions
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Vocal Cord Dysfunction

Intervention / Treatment
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* Biological: Autologous fat transplantation
* Biological: Functional collagen scaffold transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18-65 years old, male or female Severe unilateral vocal cord injury and poor closure of the glottis Disease course was more than 1 year At least two GRBAS scores reach 2 points or more The subjects have read and fully understood the research notes, signed informed consent Exclusion Criteria: Over speaking professionals, such as teachers, shop assistants. With vital organ dysfunction, such as heart, lung, liver or kidney. Pregnant or lactating women, or in preconception period. Allergic to various drugs. Difficult to be followed-up or cooperate long-termly. Participated in other clinical trials in the last 3 months. With progressive severe disease. Alcoholics or drug addicts. Unable to execute clinical study protocol due to severe mental disorders or lingual barriers With inevitable circumstances of voice damage. Any other unsuitable conditions for the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous fat transplantation<br> | Biological: Autologous fat transplantation<br>* Autologous abdominal fat will be injected into vocal cord beneath mucous under surgery microscope.<br>|
| Experimental: Functional collagen scaffold transplantation<br> | Biological: Functional collagen scaffold transplantation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in subjective auditory perception score |  | 1 week, 2 week, 1,3,6,12 month after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |