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

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

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.

Study Overview

• Status: Completed
• Conditions: Vocal Cord Dysfunction
• Intervention / Treatment: Biological: Autologous fat transplantation; Biological: Functional collagen scaffold transplantation

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100032
    • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Functional collagen scaffold transplantation	Biological: Functional collagen scaffold transplantation; 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.
Experimental: Autologous fat transplantation	Biological: Autologous fat transplantation; Autologous abdominal fat will be injected into vocal cord beneath mucous under surgery microscope.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in subjective auditory perception score	1 week, 2 week, 1,3,6,12 month after intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in voice handicap index (VHI) scale	1 week, 2 week, 1,3,6,12 month after intervention
Objective acoustic evaluation (Jitter)	1 week, 2 week, 1,3,6,12 month after intervention
Objective acoustic evaluation (Shimmer)	1 week, 2 week, 1,3,6,12 month after intervention
Objective acoustic evaluation (Normalized noise energy)	1 week, 2 week, 1,3,6,12 month after intervention
Objective acoustic evaluation（Maximum phonation time）	1 week, 2 week, 1,3,6,12 month after intervention
Physical status assessment of vocal cords（Motor test of vocal cords）	1 week, 2 week, 1,3,6,12 month after intervention
Physical status assessment of vocal cords （Closing test of vocal cords）	1 week, 2 week, 1,3,6,12 month after intervention
Physical status assessment of vocal cords （Morphology of vocal cords）	1 week, 2 week, 1,3,6,12 month after intervention
Change in volume of vocal cords	1 week, 2 week, 1,3,6,12 month after intervention

Collaborators and Investigators

• Sponsor: Chinese Academy of Sciences
• Collaborators: Peking Union Medical College

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: April 19, 2016
• First Submitted That Met QC Criteria: April 25, 2016
• First Posted (Estimate): April 28, 2016

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 31, 2020
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Laryngeal Diseases; Vocal Cord Dysfunction
• Other Study ID Numbers: CAS-XDA-LST/IGDB