Vocal Cord DysfunctionPhase 1NCT02754284
Clinical Study of Regeneration on Larynx Soft Tissue Guided by Functional Collagen Scaffold
A Phase 1 study testing Autologous fat transplantation and Functional collagen scaffold transplantation in people with Vocal Cord Dysfunction, run by Chinese Academy of Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vocal Cord Dysfunction
- What is being tested?
- Autologous fat transplantation and Functional collagen scaffold transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Jun 2020
- Phase
- Phase 1
- 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
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, 100032
About this study
Official title: The Safety and Efficacy Assessment of Functional Collagen Scaffold Transplantation for Larynx Soft Tissue Regeneration
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
- Vocal Cord Dysfunction
- Being tested
- Autologous fat transplantation, Functional collagen scaffold transplantation
- Medical subject headings
- Vocal Cord Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous fat transplantationBiological
Autologous abdominal fat will be injected into vocal cord beneath mucous under surgery microscope.
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.
| Study group | Role | What they receive |
|---|---|---|
| Autologous fat transplantation | Experimental | Not described Receives: Biological: Autologous fat transplantation |
| Functional collagen scaffold transplantation | Experimental | Not described Receives: Biological: Functional collagen scaffold transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in subjective auditory perception score
Measured: 1 week, 2 week, 1,3,6,12 month after intervention
Secondary outcomes (9)
Change in voice handicap index (VHI) scale
Measured: 1 week, 2 week, 1,3,6,12 month after intervention
Objective acoustic evaluation (Jitter)
Measured: 1 week, 2 week, 1,3,6,12 month after intervention
Objective acoustic evaluation (Shimmer)
Measured: 1 week, 2 week, 1,3,6,12 month after intervention
Objective acoustic evaluation (Normalized noise energy)
Measured: 1 week, 2 week, 1,3,6,12 month after intervention
Objective acoustic evaluation（Maximum phonation time）
Measured: 1 week, 2 week, 1,3,6,12 month after intervention
Physical status assessment of vocal cords（Motor test of vocal cords）
Measured: 1 week, 2 week, 1,3,6,12 month after intervention
Physical status assessment of vocal cords （Closing test of vocal cords）
Measured: 1 week, 2 week, 1,3,6,12 month after intervention
Physical status assessment of vocal cords （Morphology of vocal cords）
Measured: 1 week, 2 week, 1,3,6,12 month after intervention
Change in volume of vocal cords
Measured: 1 week, 2 week, 1,3,6,12 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startDec 2015
- Primary completionJun 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vocal Cord DysfunctionStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
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
- NCT02754284
- Sponsor's protocol ID
- CAS-XDA-LST/IGDB
- Status last verified
- Apr 2016
- First submitted
- 19 Apr 2016
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy Assessment of Functional Collagen Scaffold Transplantation for Larynx Soft Tissue Regeneration
- ClinicalTrials.gov ID
- NCT02754284
- Acronym / sponsor ID
- CAS-XDA-LST/IGDB
- Conditions
- Vocal Cord Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Collaborators
- Peking Union Medical College
- Study start
- Dec 2015
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 28 Apr 2016 (estimated)
- 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.
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 |
|---|---|---|
| Autologous fat transplantation | Experimental | Biological: Autologous fat transplantation |
| Functional collagen scaffold transplantation | Experimental | Biological: Functional collagen scaffold 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
- 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
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| Autologous fat transplantationAutologous abdominal fat will be injected into vocal cord beneath mucous under surgery microscope. | Biological | Autologous fat transplantation |
| Functional collagen scaffold transplantationInjectable 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. | Biological | Functional collagen scaffold transplantation |
Primary outcome
Change in subjective auditory perception score
Time frame: 1 week, 2 week, 1,3,6,12 month after intervention
9 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
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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 study testing Autologous fat transplantation and Functional collagen scaffold transplantation in people with Vocal Cord Dysfunction, 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 11 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: finished, as of the sponsor's last update on 5 Jan 2021. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in subjective auditory perception score (time frame: 1 week, 2 week, 1,3,6,12 month after intervention). 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 5 Jan 2021.