Innovative Treatment for Scarred Vocal Cords by Local Injection of Autologous Stromal Vascular Fraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- safety will be assessed by the absence of related events related to stromal vascular fraction injection injected in vocal cords
研究概览
简要总结
Post-operative scarring on vocal cords is responsible for disorders of the vibration of the lining to the original dysphonia can be troublesome for the patient both in his private and professional life. There is no currently codified treatment for this type of situation and no therapeutic antifibrotic has been effective. Cell therapy is a promising new approach.After a liposuction and removing of mature adipocytes (40 to 60%), the remaining cells called stromal vascular fraction (SVF) could be isolated. SVF consists of a heterogeneous cell population including multipotent stem cells similar to mesenchymal stem cells present in bone marrow. The investigators hypothesis is that the trophic and antifibrotic properties of SVF could benefit patients with vocal cords scarring responsible for dysphonia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Vocal Difficulties felt as crippling (VHI > 60/120)
- •Presence of scar hurts of the caused vocal cords is by the initial surgery (micro-laryngoscopy in suspension with or without laser) or by a congenital pathology of glottidis sulcus
- •Scar Aspect of vocal cords judged on a stroboscopic examination
- •Delay of at least 1 year with regard to the initial surgery
排除标准
- •Patients refusing the speech therapy
- •Patients operated for a malignant lesion or in malignant potential serious dysplasia of the scar vocal cord
- •Contraindication in the anesthesia
- •Patients under anti-coagulants
- •Patients presenting disorders of the coagulation
- •Active infectious diseases
研究组 & 干预措施
micro injection of SVF in vocal cords
micro injection of Stromal Vascular Fraction extracted from autologous adipose tissue in vocal cords
干预措施: micro injection of SVF in vocal cords (Other)
结局指标
主要结局
safety will be assessed by the absence of related events related to stromal vascular fraction injection injected in vocal cords
时间窗: 13 months
safety of Stromal Vascular Fraction injection injected in vocal cords
feasibility of Stromal Vascular Fraction injection injected in vocal cords
时间窗: 13 months
feasibility will be assessed by observation of the immediate volumizing effect on the edge free of the vocal cord appreciated on the video document
次要结局
- efficiency of SVF injection for the treatment of scarred vocal cords with improved instrumental objective characteristics of the voice of the operated patients(13 months)