Functional Collagen Scaffold for Laryngeal Soft Tissue Regeneration

Clinical Study of Functional Collagen Scaffold Transplantation for Laryngeal Soft Tissue Regeneration

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.

Study Overview

• Status: Unknown
• Conditions: Glottic Insufficiency
• Intervention / Treatment: Biological: Functional collagen scaffold transplantation; Biological: Autologous adipose cell transplantation

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100032
    • Recruiting
    • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
    • Contact: Jian Wang, M.D.; Phone Number: 86-10-69152720; Email: wangjianent@126.com
    • Contact: Xiaofeng Jin, M.D.; Phone Number: 86-10-69152720; Email: jxf.pumch@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age of 18-65 years old, male or female
2. 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. With malignant tumors
4. Pregnant or lactating women, or in preconception period
5. History of drug allergy
6. Difficult to be followed-up or cooperate long-termly
7. Participated in other clinical trials in the last 3 months
8. With severe progressive diseases
9. Alcoholics or drug addicts
10. Unable to execute clinical study protocol due to severe mental disorders or lingual barriers
11. With inevitable circumstances of voice damage
12. Any other unsuitable conditions for the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Functional collagen scaffold transplantation	Biological: Functional collagen scaffold transplantation; Injectable collagen scaffold combined with autologous adipose-derived cells will be injected into submucosa of vocal cord and paraglottic space under the surgical microscope
Experimental: Autologous adipose cell transplantation	Biological: Autologous adipose cell transplantation; Autologous adipose-derived cells will be injected into the submucosa of vocal cord and paraglottic space under the surgical microscope

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese Academy of Sciences
• Collaborators: Peking Union Medical College

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: November 14, 2019
• First Posted (Actual): November 15, 2019

Study Record Updates

• Last Update Posted (Actual): November 15, 2019
• Last Update Submitted That Met QC Criteria: November 14, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CAS-XDA-LSTR/IGDB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No