Clinical Study of Regeneration on Larynx Soft Tissue Guided by Functional Collagen Scaffold
NCT ID: NCT02754284
Last Updated: 2021-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2015-12-31
2020-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Autologous fat transplantation
Autologous fat transplantation
Autologous abdominal fat will be injected into vocal cord beneath mucous under surgery microscope.
Functional collagen scaffold transplantation
Functional collagen scaffold transplantation
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.
Interventions
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Autologous fat transplantation
Autologous abdominal fat will be injected into vocal cord beneath mucous under surgery microscope.
Functional collagen scaffold transplantation
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.
Eligibility Criteria
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Inclusion Criteria
2. Severe 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
2. With vital organ dysfunction, such as heart, lung, liver or kidney.
3. Pregnant or lactating women, or in preconception period.
4. Allergic to various drugs.
5. Difficult to be followed-up or cooperate long-termly.
6. Participated in other clinical trials in the last 3 months.
7. With progressive severe disease.
8. Alcoholics or drug addicts.
9. Unable to execute clinical study protocol due to severe mental disorders or lingual barriers
10. With inevitable circumstances of voice damage.
11. Any other unsuitable conditions for the study.
18 Years
65 Years
ALL
No
Sponsors
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Peking Union Medical College
OTHER
Chinese Academy of Sciences
OTHER_GOV
Responsible Party
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Jianwu Dai
Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS
Principal Investigators
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Jianwu Dai, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Sciences
Locations
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Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, , China
Countries
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Other Identifiers
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CAS-XDA-LST/IGDB
Identifier Type: -
Identifier Source: org_study_id
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