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

Vocal Cord Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02754284
• Other study ID #: CAS-XDA-LST/IGDB
• Status: Completed
• Phase: Phase 1
• Start date: December 2015
• Est. completion date: June 2020

Study information

• Verified date: April 2016
• Source: Chinese Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vocal Cord Dysfunction

Intervention

Biological:
• Autologous fat transplantation
Autologous abdominal fat will be injected into vocal cord beneath mucous under surgery microscope.
• 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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital, Chinese Academy of Medical Sciences	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Academy of Sciences	Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in subjective auditory perception score		1 week, 2 week, 1,3,6,12 month after intervention
Secondary	Change in voice handicap index (VHI) scale		1 week, 2 week, 1,3,6,12 month after intervention
Secondary	Objective acoustic evaluation (Jitter)		1 week, 2 week, 1,3,6,12 month after intervention
Secondary	Objective acoustic evaluation (Shimmer)		1 week, 2 week, 1,3,6,12 month after intervention
Secondary	Objective acoustic evaluation (Normalized noise energy)		1 week, 2 week, 1,3,6,12 month after intervention
Secondary	Objective acoustic evaluation(Maximum phonation time)		1 week, 2 week, 1,3,6,12 month after intervention
Secondary	Physical status assessment of vocal cords(Motor test of vocal cords)		1 week, 2 week, 1,3,6,12 month after intervention
Secondary	Physical status assessment of vocal cords (Closing test of vocal cords)		1 week, 2 week, 1,3,6,12 month after intervention
Secondary	Physical status assessment of vocal cords (Morphology of vocal cords)		1 week, 2 week, 1,3,6,12 month after intervention
Secondary	Change in volume of vocal cords		1 week, 2 week, 1,3,6,12 month after intervention