Clinical Study of Functional Collagen Scaffold Transplantation for Laryngeal Soft Tissue Regeneration
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- GRBAS scale
研究概览
简要总结
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.
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
- •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
- •With malignant tumors
- •Pregnant or lactating women, or in preconception period
- •History of drug allergy
- •Difficult to be followed-up or cooperate long-termly
- •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
结局指标
主要结局
GRBAS scale
时间窗: 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
次要结局
- Maximum phonation time (MPT)(1 week, 1, 3, 6, 9, 12 month after intervention)
- Volume of vocal cords(Baseline, 1 year, 2 year after intervention)
- Jitter(1 week, 1, 3, 6, 9, 12 month after intervention)
- Normalized noise energy (NNE)(1 week, 1, 3, 6, 9, 12 month after intervention)
- Voice handicap index (VHI) scale(1 week, 1, 3, 6, 9, 12 month after intervention)
- Shimmer(1 week, 1, 3, 6, 9, 12 month after intervention)
- Physical status of vocal cords(1 week, 1, 3, 6, 9, 12, 24 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