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

Chinese Academy of Sciences20 enrolled

Overview

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

Vocal Cord Dysfunction

Interventions

Autologous fat transplantationBIOLOGICAL

Autologous abdominal fat will be injected into vocal cord beneath mucous under surgery microscope.

Functional collagen scaffold transplantationBIOLOGICAL

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.

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. Severe 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. Pregnant or lactating women, or in preconception period. 4. Allergic to various drugs. 5. Difficult to be followed-up or cooperate long-termly. 6. Participated in other clinical trials in the last 3 months. 7. With progressive severe disease. 8. Alcoholics or drug addicts. 9. Unable to execute clinical study protocol due to severe mental disorders or lingual barriers 10. With inevitable circumstances of voice damage. 11. Any other unsuitable conditions for the study.

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, China