Functional Collagen Scaffold for Laryngeal Soft Tissue Regeneration

Chinese Academy of Sciences

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Glottic Insufficiency

Treatments: Biological: Autologous adipose cell transplantation; Biological: Functional collagen scaffold transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT04164485

CAS-XDA-LSTR/IGDB

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Functional collagen scaffold transplantation

Experimental group

Treatment:

Biological: Functional collagen scaffold transplantation

Autologous adipose cell transplantation

Experimental group

Treatment:

Biological: Autologous adipose cell transplantation