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Clinical Trials/NCT02754284
NCT02754284CompletedPhase 1

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

Chinese Academy of Sciences2 sites in 1 country20 target enrollmentStarted: December 2015Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
20
Locations
2
Primary Endpoint
Change in subjective auditory perception score
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
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

  • •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.

Outcomes

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(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)
  • 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)
  • 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)

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Jianwu Dai

Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS

Chinese Academy of Sciences

Study Sites (2)

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