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Functional Collagen Scaffold for Laryngeal Soft Tissue Regeneration

NCT04164485 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-11-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Peking Union Medical College

    collaborator OTHER

  • Chinese Academy of Sciences

    lead OTHER_GOV

Principal Investigators

  • Jianwu Dai, Ph.D · Chinese Academy of Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04164485 on ClinicalTrials.gov