Functional Collagen Scaffold for Laryngeal Soft Tissue Regeneration

Study Overview
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Brief Summary
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Unilateral vocal cord paralysis (UVCP) is a clinical condition and often leads to glottic insufficiency. The presence of glottic insufficiency can result in poor pronunciation quality, vocal fatigue, shortness of breath with speaking, and in some cases, it could lead to unable to pronounce, dysphagia and aspiration, severely decreasing quality of life for its victims. 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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Clinical Study of Functional Collagen Scaffold Transplantation for Laryngeal Soft Tissue Regeneration

Conditions
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Glottic Insufficiency

Intervention / Treatment
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* Biological: Functional collagen scaffold transplantation
* Biological: Autologous adipose cell transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18-65 years old, male or female 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 With malignant tumors Pregnant or lactating women, or in preconception period History of drug allergy Difficult to be followed-up or cooperate long-termly Participated in other clinical trials in the last 3 months With severe progressive diseases 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: Functional collagen scaffold transplantation<br> | Biological: Functional collagen scaffold transplantation<br>* Injectable collagen scaffold combined with autologous adipose-derived cells will be injected into submucosa of vocal cord and paraglottic space under the surgical microscope<br>|
| Experimental: Autologous adipose cell transplantation<br> | Biological: Autologous adipose cell transplantation<br>* Autologous adipose-derived cells will be injected into the submucosa of vocal cord and paraglottic space under the surgical microscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GRBAS scale | Auditory perceptual evaluation was assessed with a GRBAS scale, in which the voice properties, such as the grade of the severity of dysphonia (G), roughness (R), breathiness (B), asthenia (A), and strain (S), are scored on a four-point scale: 0 = normal, 1 = slight deviance, 2 = moderate deviance, and 3 = severe deviance | 1 week after intervention | 
| GRBAS scale | Auditory perceptual evaluation was assessed with a GRBAS scale, in which the voice properties, such as the grade of the severity of dysphonia (G), roughness (R), breathiness (B), asthenia (A), and strain (S), are scored on a four-point scale: 0 = normal, 1 = slight deviance, 2 = moderate deviance, and 3 = severe deviance | 1 month after intervention | 
| GRBAS scale | Auditory perceptual evaluation was assessed with a GRBAS scale, in which the voice properties, such as the grade of the severity of dysphonia (G), roughness (R), breathiness (B), asthenia (A), and strain (S), are scored on a four-point scale: 0 = normal, 1 = slight deviance, 2 = moderate deviance, and 3 = severe deviance | 3 month after intervention | 
| GRBAS scale | Auditory perceptual evaluation was assessed with a GRBAS scale, in which the voice properties, such as the grade of the severity of dysphonia (G), roughness (R), breathiness (B), asthenia (A), and strain (S), are scored on a four-point scale: 0 = normal, 1 = slight deviance, 2 = moderate deviance, and 3 = severe deviance | 6 month after intervention | 
| GRBAS scale | Auditory perceptual evaluation was assessed with a GRBAS scale, in which the voice properties, such as the grade of the severity of dysphonia (G), roughness (R), breathiness (B), asthenia (A), and strain (S), are scored on a four-point scale: 0 = normal, 1 = slight deviance, 2 = moderate deviance, and 3 = severe deviance | 9 month after intervention | 
| GRBAS scale | Auditory perceptual evaluation was assessed with a GRBAS scale, in which the voice properties, such as the grade of the severity of dysphonia (G), roughness (R), breathiness (B), asthenia (A), and strain (S), are scored on a four-point scale: 0 = normal, 1 = slight deviance, 2 = moderate deviance, and 3 = severe deviance | 12 month after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voice handicap index (VHI) scale | The Voice Handicap Index (VHI) is a 30-item test divided into 3 subscales that measure the functional, physical and emotional features of the disability caused by voice impairment was used for patient self-assessment. The subscale scores ranged from 0 to 40, and the total ranged from 0 to 120, with a higher score indicating a greater degree of disability | 1 week, 1, 3, 6, 9, 12 month after intervention | 
| Jitter | Acoustic voice analysis parameter. Jitter is for short and middle term pitch perturbation analysis | 1 week, 1, 3, 6, 9, 12 month after intervention | 
| Shimmer | Acoustic voice analysis parameter. Shimmer is for short and middle term amplitude perturbation analysis | 1 week, 1, 3, 6, 9, 12 month after intervention | 
| Normalized noise energy (NNE) | Acoustic voice analysis parameter. Normalized Noise Energy (NNE) is automatically computed from the voice signals using an adaptive comb filtering method performed in the frequency domain | 1 week, 1, 3, 6, 9, 12 month after intervention | 
| Maximum phonation time (MPT) | Acoustic voice analysis parameter. Maximum phonation time (MPT) represents the maximum time that an individual can sustain the vowel /a/ at a comfortable pitch and loudness | 1 week, 1, 3, 6, 9, 12 month after intervention | 
| Physical status of vocal cords | The morphology of vocal cords (thin or fat, smooth or rough, plump or atrophy), motor function of vocal cords (normal, limited or fixed) and glottic closure (yes or no) were observed by fiber laryngoscopy | 1 week, 1, 3, 6, 9, 12, 24 month after intervention | 
| Volume of vocal cords | The volume of vocal cords was evaluated by Computed tomography (CT) | Baseline, 1 year, 2 year after intervention |