NCT02754284

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

January 5, 2021

Status Verified

April 1, 2016

Enrollment Period

4.5 years

First QC Date

April 19, 2016

Last Update Submit

December 31, 2020

Conditions

Vocal Cord Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Change in subjective auditory perception score

    1 week, 2 week, 1,3,6,12 month after intervention

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

Autologous fat transplantation

EXPERIMENTAL
Biological: Autologous fat transplantation

Functional collagen scaffold transplantation

EXPERIMENTAL
Biological: Functional collagen scaffold transplantation

Interventions

Autologous fat transplantationBIOLOGICAL

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

Autologous fat transplantation
Functional collagen scaffold transplantationBIOLOGICAL

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.

Functional collagen scaffold transplantation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, 100032, China

Location

MeSH Terms

Conditions

Vocal Cord Dysfunction

Condition Hierarchy (Ancestors)

Laryngeal DiseasesRespiratory Tract DiseasesRespiration DisordersOtorhinolaryngologic Diseases

Study Officials

  • Jianwu Dai, Ph.D

    Chinese Academy of Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS

Study Record Dates

First Submitted

April 19, 2016

First Posted

April 28, 2016

Study Start

December 1, 2015

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

January 5, 2021

Record last verified: 2016-04

Locations

CN(1)