INNOVATIVE TREATMENT OF SCARRED VOCAL FOLDS BY LOCAL INJECTION OF AUTOLOGOUS ADIPOSE-DERIVED STROMAL VASCULAR FRACTION: EFFICACY VERSUS PLACEBO
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Changes from baseline in Self-evaluation with the Voice Handicap Index (VHI), a shift in the total score of 18 points or greater being required to be clinically significant (Jacobson, 1997)
研究概览
简要总结
Evaluate and compare the efficacy of fresh autologous adipose-derived stromal vascular fraction injection, in comparison with a placebo (saline solution and human serum albumin, vehicle of SVF without cells), on dysphonia linked to scarred vocal cords, based on a self-assessment via the Voice Handicap Index (significant improvement if ≥ 18 points according to Jacobson) at 6 months post treatment.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Subscription to the French Social Security System
- •Voice Handicap Index > 50/120
- •Scarred vocal folds, congenital (sulcus) or after phonosurgery
- •Scarred middle third in videolaryngostroboscopy
- •At least six-months delay after initial surgery if appropriate
- •Patients aged between 18 and 70
- •Good general condition
- •Negative pregnancy test & contraception for women of child-bearing age
排除标准
- •Refusal of speech therapy
- •BMI < 18 kg/m2 to insure adequate abdominal or other subcutaneous adipose tissue accessible to lipoharvest
- •History of malignant lesion or severe dysplasia of the scarred vocal fold
- •History of laryngeal papillomatosis
- •Contre-indication à l'anesthésie locale
- •Anti-coagulant treatment
- •Coagulation disorders (Prothrombin Ratio <65%, Activated Partial Thromboplastin Time >1,2)
- •Active infectious diseases
- •Any active viral infection from among the following: HIV, HTLV I and II, VHB, VHC and Syphilis
- •Known sensitivity to human serum albumin (HSA)
结局指标
主要结局
Changes from baseline in Self-evaluation with the Voice Handicap Index (VHI), a shift in the total score of 18 points or greater being required to be clinically significant (Jacobson, 1997)
Changes from baseline in Self-evaluation with the Voice Handicap Index (VHI), a shift in the total score of 18 points or greater being required to be clinically significant (Jacobson, 1997)
次要结局
- VHI at 1 month
- self-evaluation of dysphonia (0-10 scale)
- voice acoustic measurements
- voice aerodynamic measurements: maximum phonation time
- perceptive analysis (GRB scale): score will be calculated by addition of two characteristics
- videolaryngostroboscopy
- The incidence of related Adverse Events
研究者
Alexia Mattei
Scientific
Centre Hospitalier Regional De Marseille