Functional Collagen Scaffold for Laryngeal Soft Tissue Regeneration

November 14, 2019 updated by: Jianwu Dai, Chinese Academy of Sciences

Clinical Study of Functional Collagen Scaffold Transplantation for Laryngeal Soft Tissue Regeneration

Unilateral vocal cord paralysis (UVCP) is a clinical condition and often leads to glottic insufficiency. The presence of glottic insufficiency can result in poor pronunciation quality, vocal fatigue, shortness of breath with speaking, and in some cases, it could lead to unable to pronounce, dysphagia and aspiration, severely decreasing quality of life for its victims. 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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 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. 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. With malignant tumors
  4. Pregnant or lactating women, or in preconception period
  5. History of drug allergy
  6. Difficult to be followed-up or cooperate long-termly
  7. Participated in other clinical trials in the last 3 months
  8. With severe progressive diseases
  9. Alcoholics or drug addicts
  10. Unable to execute clinical study protocol due to severe mental disorders or lingual barriers
  11. With inevitable circumstances of voice damage
  12. Any other unsuitable conditions for the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Functional collagen scaffold transplantation
Biological: Functional collagen scaffold transplantation
Injectable collagen scaffold combined with autologous adipose-derived cells will be injected into submucosa of vocal cord and paraglottic space under the surgical microscope
Experimental: Autologous adipose cell transplantation
Biological: Autologous adipose cell transplantation
Autologous adipose-derived cells will be injected into the submucosa of vocal cord and paraglottic space under the surgical microscope

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
GRBAS scale
Time Frame: 1 week after intervention
Auditory perceptual evaluation was assessed with a GRBAS scale, in which the voice properties, such as the grade of the severity of dysphonia (G), roughness (R), breathiness (B), asthenia (A), and strain (S), are scored on a four-point scale: 0 = normal, 1 = slight deviance, 2 = moderate deviance, and 3 = severe deviance
1 week after intervention
GRBAS scale
Time Frame: 1 month after intervention
Auditory perceptual evaluation was assessed with a GRBAS scale, in which the voice properties, such as the grade of the severity of dysphonia (G), roughness (R), breathiness (B), asthenia (A), and strain (S), are scored on a four-point scale: 0 = normal, 1 = slight deviance, 2 = moderate deviance, and 3 = severe deviance
1 month after intervention
GRBAS scale
Time Frame: 3 month after intervention
Auditory perceptual evaluation was assessed with a GRBAS scale, in which the voice properties, such as the grade of the severity of dysphonia (G), roughness (R), breathiness (B), asthenia (A), and strain (S), are scored on a four-point scale: 0 = normal, 1 = slight deviance, 2 = moderate deviance, and 3 = severe deviance
3 month after intervention
GRBAS scale
Time Frame: 6 month after intervention
Auditory perceptual evaluation was assessed with a GRBAS scale, in which the voice properties, such as the grade of the severity of dysphonia (G), roughness (R), breathiness (B), asthenia (A), and strain (S), are scored on a four-point scale: 0 = normal, 1 = slight deviance, 2 = moderate deviance, and 3 = severe deviance
6 month after intervention
GRBAS scale
Time Frame: 9 month after intervention
Auditory perceptual evaluation was assessed with a GRBAS scale, in which the voice properties, such as the grade of the severity of dysphonia (G), roughness (R), breathiness (B), asthenia (A), and strain (S), are scored on a four-point scale: 0 = normal, 1 = slight deviance, 2 = moderate deviance, and 3 = severe deviance
9 month after intervention
GRBAS scale
Time Frame: 12 month after intervention
Auditory perceptual evaluation was assessed with a GRBAS scale, in which the voice properties, such as the grade of the severity of dysphonia (G), roughness (R), breathiness (B), asthenia (A), and strain (S), are scored on a four-point scale: 0 = normal, 1 = slight deviance, 2 = moderate deviance, and 3 = severe deviance
12 month after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Voice handicap index (VHI) scale
Time Frame: 1 week, 1, 3, 6, 9, 12 month after intervention
The Voice Handicap Index (VHI) is a 30-item test divided into 3 subscales that measure the functional, physical and emotional features of the disability caused by voice impairment was used for patient self-assessment. The subscale scores ranged from 0 to 40, and the total ranged from 0 to 120, with a higher score indicating a greater degree of disability
1 week, 1, 3, 6, 9, 12 month after intervention
Jitter
Time Frame: 1 week, 1, 3, 6, 9, 12 month after intervention
Acoustic voice analysis parameter. Jitter is for short and middle term pitch perturbation analysis
1 week, 1, 3, 6, 9, 12 month after intervention
Shimmer
Time Frame: 1 week, 1, 3, 6, 9, 12 month after intervention
Acoustic voice analysis parameter. Shimmer is for short and middle term amplitude perturbation analysis
1 week, 1, 3, 6, 9, 12 month after intervention
Normalized noise energy (NNE)
Time Frame: 1 week, 1, 3, 6, 9, 12 month after intervention
Acoustic voice analysis parameter. Normalized Noise Energy (NNE) is automatically computed from the voice signals using an adaptive comb filtering method performed in the frequency domain
1 week, 1, 3, 6, 9, 12 month after intervention
Maximum phonation time (MPT)
Time Frame: 1 week, 1, 3, 6, 9, 12 month after intervention
Acoustic voice analysis parameter. Maximum phonation time (MPT) represents the maximum time that an individual can sustain the vowel /a/ at a comfortable pitch and loudness
1 week, 1, 3, 6, 9, 12 month after intervention
Physical status of vocal cords
Time Frame: 1 week, 1, 3, 6, 9, 12, 24 month after intervention
The morphology of vocal cords (thin or fat, smooth or rough, plump or atrophy), motor function of vocal cords (normal, limited or fixed) and glottic closure (yes or no) were observed by fiber laryngoscopy
1 week, 1, 3, 6, 9, 12, 24 month after intervention
Volume of vocal cords
Time Frame: Baseline, 1 year, 2 year after intervention
The volume of vocal cords was evaluated by Computed tomography (CT)
Baseline, 1 year, 2 year after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese Academy of Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Peking Union Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CAS-XDA-LSTR/IGDB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings