NCT02754284已完成1 期
The Safety and Efficacy Assessment of Functional Collagen Scaffold Transplantation for Larynx Soft Tissue Regeneration
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in subjective auditory perception score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Autologous fat transplantation
Experimental
干预措施: Autologous fat transplantation (Biological)
Functional collagen scaffold transplantation
Experimental
干预措施: Functional collagen scaffold transplantation (Biological)
结局指标
主要结局
Change in subjective auditory perception score
时间窗: 1 week, 2 week, 1,3,6,12 month after intervention
次要结局
- Objective acoustic evaluation（Maximum phonation time）(1 week, 2 week, 1,3,6,12 month after intervention)
- Physical status assessment of vocal cords（Motor test of vocal cords）(1 week, 2 week, 1,3,6,12 month after intervention)
- Physical status assessment of vocal cords （Closing test of vocal cords）(1 week, 2 week, 1,3,6,12 month after intervention)
- Physical status assessment of vocal cords （Morphology of vocal cords）(1 week, 2 week, 1,3,6,12 month after intervention)
- Change in volume of vocal cords(1 week, 2 week, 1,3,6,12 month after intervention)
- 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)
研究者
Jianwu Dai
Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS
Chinese Academy of Sciences
研究点 (1)
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