Skip to main content
OpenTrials
Completed

NCT Number: NCT02754284

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vocal Cord Dysfunction Laryngeal Diseases Otorhinolaryngologic Diseases Respiration Disorders Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, 100032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autologous fat transplantation

Biological

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

Functional collagen scaffold transplantation

Biological

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.

Primary outcomes

  1. Change in subjective auditory perception score

    Time frame: 1 week, 2 week, 1,3,6,12 month after intervention

Secondary outcomes

  1. Change in voice handicap index (VHI) scale

    Time frame: 1 week, 2 week, 1,3,6,12 month after intervention

  2. Objective acoustic evaluation (Jitter)

    Time frame: 1 week, 2 week, 1,3,6,12 month after intervention

  3. Objective acoustic evaluation (Shimmer)

    Time frame: 1 week, 2 week, 1,3,6,12 month after intervention

  4. Objective acoustic evaluation (Normalized noise energy)

    Time frame: 1 week, 2 week, 1,3,6,12 month after intervention

  5. Objective acoustic evaluation（Maximum phonation time）

    Time frame: 1 week, 2 week, 1,3,6,12 month after intervention

  6. Physical status assessment of vocal cords（Motor test of vocal cords）

    Time frame: 1 week, 2 week, 1,3,6,12 month after intervention

  7. Physical status assessment of vocal cords （Closing test of vocal cords）

    Time frame: 1 week, 2 week, 1,3,6,12 month after intervention

  8. Physical status assessment of vocal cords （Morphology of vocal cords）

    Time frame: 1 week, 2 week, 1,3,6,12 month after intervention

  9. Change in volume of vocal cords

    Time frame: 1 week, 2 week, 1,3,6,12 month after intervention

Sponsors and collaborators

Lead sponsor

Chinese Academy of Sciences

Other Gov

Collaborators

  • Peking Union Medical College

Registry information

Official study title

The Safety and Efficacy Assessment of Functional Collagen Scaffold Transplantation for Larynx Soft Tissue Regeneration

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Apr 28, 2016
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.