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

Primary Purpose

Vocal Cord Dysfunction

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Autologous fat transplantation
Functional collagen scaffold transplantation
Sponsored by
Chinese Academy of Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vocal Cord Dysfunction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age of 18-65 years old, male or female
  2. Severe 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. Pregnant or lactating women, or in preconception period.
  4. Allergic to various drugs.
  5. Difficult to be followed-up or cooperate long-termly.
  6. Participated in other clinical trials in the last 3 months.
  7. With progressive severe disease.
  8. Alcoholics or drug addicts.
  9. Unable to execute clinical study protocol due to severe mental disorders or lingual barriers
  10. With inevitable circumstances of voice damage.
  11. Any other unsuitable conditions for the study.

Sites / Locations

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Autologous fat transplantation

Functional collagen scaffold transplantation

Arm Description

Outcomes

Primary Outcome Measures

Change in subjective auditory perception score

Secondary Outcome Measures

Change in voice handicap index (VHI) scale
Objective acoustic evaluation (Jitter)
Objective acoustic evaluation (Shimmer)
Objective acoustic evaluation (Normalized noise energy)
Objective acoustic evaluation（Maximum phonation time）
Physical status assessment of vocal cords（Motor test of vocal cords）
Physical status assessment of vocal cords （Closing test of vocal cords）
Physical status assessment of vocal cords （Morphology of vocal cords）
Change in volume of vocal cords

Full Information

First Posted
April 19, 2016
Last Updated
December 31, 2020
Sponsor
Chinese Academy of Sciences
Collaborators
Peking Union Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT02754284
Brief Title
Clinical Study of Regeneration on Larynx Soft Tissue Guided by Functional Collagen Scaffold
Official Title
The Safety and Efficacy Assessment of Functional Collagen Scaffold Transplantation for Larynx Soft Tissue Regeneration
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Sciences
Collaborators
Peking Union Medical College

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vocal Cord Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous fat transplantation
Arm Type
Experimental
Arm Title
Functional collagen scaffold transplantation
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Autologous fat transplantation
Intervention Description
Autologous abdominal fat will be injected into vocal cord beneath mucous under surgery microscope.
Intervention Type
Biological
Intervention Name(s)
Functional collagen scaffold transplantation
Intervention Description
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 Outcome Measure Information:
Title
Change in subjective auditory perception score
Time Frame
1 week, 2 week, 1,3,6,12 month after intervention
Secondary Outcome Measure Information:
Title
Change in voice handicap index (VHI) scale
Time Frame
1 week, 2 week, 1,3,6,12 month after intervention
Title
Objective acoustic evaluation (Jitter)
Time Frame
1 week, 2 week, 1,3,6,12 month after intervention
Title
Objective acoustic evaluation (Shimmer)
Time Frame
1 week, 2 week, 1,3,6,12 month after intervention
Title
Objective acoustic evaluation (Normalized noise energy)
Time Frame
1 week, 2 week, 1,3,6,12 month after intervention
Title
Objective acoustic evaluation（Maximum phonation time）
Time Frame
1 week, 2 week, 1,3,6,12 month after intervention
Title
Physical status assessment of vocal cords（Motor test of vocal cords）
Time Frame
1 week, 2 week, 1,3,6,12 month after intervention
Title
Physical status assessment of vocal cords （Closing test of vocal cords）
Time Frame
1 week, 2 week, 1,3,6,12 month after intervention
Title
Physical status assessment of vocal cords （Morphology of vocal cords）
Time Frame
1 week, 2 week, 1,3,6,12 month after intervention
Title
Change in volume of vocal cords
Time Frame
1 week, 2 week, 1,3,6,12 month after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianwu Dai, Ph.D
Organizational Affiliation
Chinese Academy of Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100032
Country
China

12. IPD Sharing Statement

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

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