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

Chinese Academy of Sciences

Status and phase

Completed

Phase 1

Conditions

Vocal Cord Dysfunction

Treatments

Biological: Functional collagen scaffold transplantation

Biological: Autologous fat transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT02754284

CAS-XDA-LST/IGDB

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age of 18-65 years old, male or female
Severe 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.
Pregnant or lactating women, or in preconception period.
Allergic to various drugs.
Difficult to be followed-up or cooperate long-termly.
Participated in other clinical trials in the last 3 months.
With progressive severe disease.
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.