Functional Collagen Scaffold for Laryngeal Soft Tissue Regeneration

Chinese Academy of Sciences60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Glottic Insufficiency

Interventions

Functional collagen scaffold transplantationBIOLOGICAL

Injectable collagen scaffold combined with autologous adipose-derived cells will be injected into submucosa of vocal cord and paraglottic space under the surgical microscope

Autologous adipose cell transplantationBIOLOGICAL

Autologous adipose-derived cells will be injected into the submucosa of vocal cord and paraglottic space under the surgical microscope

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 1 week after intervention

GRBAS scale

Time frame: 1 month after intervention

GRBAS scale

Time frame: 3 month after intervention

GRBAS scale

Time frame: 6 month after intervention

GRBAS scale

Time frame: 9 month after intervention

Central Contacts

Zhifeng Xiao, Ph.D

CONTACT

86-10-82614420 zfxiao@genetics.ac.cn

Sufang Han, Ph.D

CONTACT

86-10-82614420 sufanghan22@genetics.ac.cn

Data from ClinicalTrials.gov

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Secondary Outcomes

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