Glottic InsufficiencyPhase 1/2NCT04164485
Functional Collagen Scaffold for Laryngeal Soft Tissue Regeneration
A Phase 1/2 study testing Functional collagen scaffold transplantation and Autologous adipose cell transplantation in people with Glottic Insufficiency, run by Chinese Academy of Sciences at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Glottic Insufficiency
- What is being tested?
- Functional collagen scaffold transplantation and Autologous adipose cell transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to Dec 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18-65 years old, male or female
- 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
Who cannot join
- Over speaking professionals, such as teachers, shop assistants
- With vital organ dysfunction, such as heart, lung, liver or kidney
- With malignant tumors
- Pregnant or lactating women, or in preconception period
- History of drug allergy
- Difficult to be followed-up or cooperate long-termly
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- Participated in other clinical trials in the last 3 months
- With severe progressive diseases
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, 100032
Jian Wang, M.D., 86-10-69152720, wangjianent@126.com
Xiaofeng Jin, M.D., 86-10-69152720, jxf.pumch@qq.com
About this study
Official title: 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.
- Conditions
- Glottic Insufficiency
- Being tested
- Functional collagen scaffold transplantation, Autologous adipose cell transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional collagen scaffold transplantationBiological
Injectable collagen scaffold combined with autologous adipose-derived cells will be injected into submucosa of vocal cord and paraglottic space under the surgical microscope
Autologous adipose cell transplantationBiological
Autologous adipose-derived cells will be injected into the submucosa of vocal cord and paraglottic space under the surgical microscope
| Study group | Role | What they receive |
|---|---|---|
| Functional collagen scaffold transplantation | Experimental | Not described Receives: Biological: Functional collagen scaffold transplantation |
| Autologous adipose cell transplantation | Experimental | Not described Receives: Biological: Autologous adipose cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
GRBAS scale
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
Measured: 1 week after intervention
GRBAS scale
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
Measured: 1 month after intervention
GRBAS scale
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
Measured: 3 month after intervention
GRBAS scale
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
Measured: 6 month after intervention
GRBAS scale
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
Measured: 9 month after intervention
GRBAS scale
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
Measured: 12 month after intervention
Secondary outcomes (7)
Voice handicap index (VHI) scale
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
Measured: 1 week, 1, 3, 6, 9, 12 month after intervention
Jitter
Acoustic voice analysis parameter. Jitter is for short and middle term pitch perturbation analysis
Measured: 1 week, 1, 3, 6, 9, 12 month after intervention
Shimmer
Acoustic voice analysis parameter. Shimmer is for short and middle term amplitude perturbation analysis
Measured: 1 week, 1, 3, 6, 9, 12 month after intervention
Normalized noise energy (NNE)
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
Measured: 1 week, 1, 3, 6, 9, 12 month after intervention
Maximum phonation time (MPT)
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
Measured: 1 week, 1, 3, 6, 9, 12 month after intervention
Physical status of vocal cords
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
Measured: 1 week, 1, 3, 6, 9, 12, 24 month after intervention
Volume of vocal cords
The volume of vocal cords was evaluated by Computed tomography (CT)
Measured: Baseline, 1 year, 2 year after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start1 Jul 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glottic InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Collaborators
- Peking Union Medical College
- Responsible party
- Principal investigator, Jianwu Dai, Chinese Academy of Sciences
- Investigators
- Jianwu Dai, Ph.D, Principal investigator, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164485
- Sponsor's protocol ID
- CAS-XDA-LSTR/IGDB
- Status last verified
- Oct 2019
- First submitted
- 31 Oct 2019
- Last updated
- 15 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Functional Collagen Scaffold Transplantation for Laryngeal Soft Tissue Regeneration
- ClinicalTrials.gov ID
- NCT04164485
- Acronym / sponsor ID
- CAS-XDA-LSTR/IGDB
- Conditions
- Glottic Insufficiency
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Collaborators
- Peking Union Medical College
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional collagen scaffold transplantation | Experimental | Biological: Functional collagen scaffold transplantation |
| Autologous adipose cell transplantation | Experimental | Biological: Autologous adipose cell transplantation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age of 18-65 years old, male or female
- 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
Key exclusion criteria (12 listed)
- Over speaking professionals, such as teachers, shop assistants
- With vital organ dysfunction, such as heart, lung, liver or kidney
- With malignant tumors
- Pregnant or lactating women, or in preconception period
- History of drug allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional collagen scaffold transplantationInjectable collagen scaffold combined with autologous adipose-derived cells will be injected into submucosa of vocal cord and paraglottic space under the surgical microscope | Biological | Functional collagen scaffold transplantation |
| Autologous adipose cell transplantationAutologous adipose-derived cells will be injected into the submucosa of vocal cord and paraglottic space under the surgical microscope | Biological | Autologous adipose cell transplantation |
Primary outcome
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
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
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
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
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
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
7 secondary outcomes
Voice handicap index (VHI) scale
Time frame: 1 week, 1, 3, 6, 9, 12 month after intervention
Jitter
Time frame: 1 week, 1, 3, 6, 9, 12 month after intervention
Shimmer
Time frame: 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
Maximum phonation time (MPT)
Time frame: 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
Volume of vocal cords
Time frame: Baseline, 1 year, 2 year after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianwu Dai, Ph.D principal investigator
Chinese Academy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Functional collagen scaffold transplantation and Autologous adipose cell transplantation in people with Glottic Insufficiency, run by Chinese Academy of Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhifeng Xiao, Ph.D (86-10-82614420, zfxiao@genetics.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GRBAS scale (time frame: 1 week after intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2019.