NCT04164485

Functional Collagen Scaffold for Laryngeal Soft Tissue Regeneration

Clinical Study of Functional Collagen Scaffold Transplantation for Laryngeal Soft Tissue Regeneration

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Chinese Academy of Sciences · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glottic Insufficiency

Interventions

Type	Name	Description
BIOLOGICAL	Functional collagen scaffold transplantation	Injectable collagen scaffold combined with autologous adipose-derived cells will be injected into submucosa of vocal cord and paraglottic space under the surgical microscope
BIOLOGICAL	Autologous adipose cell transplantation	Autologous adipose-derived cells will be injected into the submucosa of vocal cord and paraglottic space under the surgical microscope

Timeline

• Start date: 2019-07-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2019-11-15
• Last updated: 2019-11-15

Locations

1 site across 1 country: China