CompletedNCT02754284Updated Jan 5, 2021

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

A Phase 1 interventional study of Autologous fat transplantation and Functional collagen scaffold transplantation in Vocal Cord Dysfunction, sponsored by Chinese Academy of Sciences. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-01-05.

Sponsored by Chinese Academy of Sciences · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 20
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Conditions studied

Vocal Cord Dysfunction

In context

Lead sponsor

Chinese Academy of Sciences is the lead sponsor of 65 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 20 participants (actual)

Study arms

Experimental
Autologous fat transplantation
Biological: Autologous fat transplantation
Experimental
Functional collagen scaffold transplantation
Biological: Functional collagen scaffold transplantation

Interventions

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

What researchers measure

Primary outcomes

Change in subjective auditory perception score
Time frame: 1 week, 2 week, 1,3,6,12 month after intervention

Secondary outcomes

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

Study locations

1 site

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02754284
Lead sponsor: Chinese Academy of Sciences
Collaborators: Peking Union Medical College
Responsible party: Jianwu Dai (Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS, Chinese Academy of Sciences) — Principal investigator
First posted: Apr 28, 2016
Start date: Dec 2015
Primary completion: Jun 2020
Completion: Jun 2020
Last update: Jan 5, 2021

Study contacts

Jianwu Dai, Ph.D

principal investigator · Chinese Academy of Sciences

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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Other studies in this condition

Vocal Cord Dysfunction

Other studies from this sponsor

Chinese Academy of Sciences

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