Functional Collagen Scaffold for Laryngeal Soft Tissue Regeneration

Phase 1

• Conditions: Glottic Insufficiency
• Interventions: Biological: Autologous adipose cell transplantation; Biological: Functional collagen scaffold transplantation

• Registration Number: NCT04164485
• Lead Sponsor: Chinese Academy of Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-01
• Status Verified: 2019-10
• Study First Submitted: 2019-10-31
• Study First Submitted QC: 2019-11-14
• Last Update Submitted: 2019-11-14
• Study First Posted: 2019-11-15
• Last Update Posted: 2019-11-15
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autologous adipose cell transplantation	Autologous adipose cell transplantation	-
Functional collagen scaffold transplantation	Functional collagen scaffold transplantation	-

Primary Outcome Measures

Name	Time	Method
GRBAS scale	12 month after intervention	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

Secondary Outcome Measures

Name	Time	Method
Jitter	1 week, 1, 3, 6, 9, 12 month after intervention	Acoustic voice analysis parameter. Jitter is for short and middle term pitch perturbation analysis
Maximum phonation time (MPT)	1 week, 1, 3, 6, 9, 12 month after intervention	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
Volume of vocal cords	Baseline, 1 year, 2 year after intervention	The volume of vocal cords was evaluated by Computed tomography (CT)
Normalized noise energy (NNE)	1 week, 1, 3, 6, 9, 12 month after intervention	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
Voice handicap index (VHI) scale	1 week, 1, 3, 6, 9, 12 month after intervention	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
Shimmer	1 week, 1, 3, 6, 9, 12 month after intervention	Acoustic voice analysis parameter. Shimmer is for short and middle term amplitude perturbation analysis
Physical status of vocal cords	1 week, 1, 3, 6, 9, 12, 24 month after intervention	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

Trial Locations

Locations (1)

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