NCT05354544终止1 期
A Pilot Study Evaluating the Safety and Feasibility of Autologous Stromal Vascular Fraction in Subjects with Vocal Fold Scar
Shane A. Shapiro1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2021年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Adverse events post SVF administration
研究概览
简要总结
The purpose of this research study is to assess if autologous Stromal Vascular Fraction (SVF) taken from the stomach or hips can help heal vocal fold scars.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Subject's age between 18 and < 80-years-old
- •Voice handicap index greater than 10/40
- •Scarred vocal folds or congenital sulcus or after vocal fold surgery (Scarring will be scored during examination and identification of scarred vocal folds and hoarseness. This criterion includes the lack of or decreased mucosal wave of the vocal fold during videostroboscopy exam. Scoring of scar based on laryngoscopic exam: Type I: atrophy of lamina propria with/without affected epithelium. Type II: the epithelium, lamina propria, and muscle are affected. Type III: scar located on the anterior commissure. Type IV: this category includes extended scar formation in both anteroposterior and rostro-caudal axis, with significant loss of vocal fold mass)
- •Unilateral or Bilateral vocal fold scarring
- •At least 1-year delay after initial surgery
- •Negative pregnancy test and contraception for woman of childbearing age. Women of childbearing age must use contraception at least 4 months pre and post SVF administration.
排除标准
- •Refusal of speech therapy
- •History of malignant lesion or severe dysplasia of the scarred vocal fold
- •Contraindication to anesthesia, anticoagulant treatment, coagulation disorders, active infectious disease
- •Refusal or inability to comply with study procedures
- •Pregnant and lactating woman
- •Major chronic medical condition that could affect treatment or quality of SVF product. These include:
- •Current treatment or within 6 months of last treatment for cancer.
- •Blindness
- •Known history of Dementia,
- •Known history of Kidney Disease
- •Known history of Cerebral Vascular Accident or Stroke
- •Known history of Diabetes
- •Abnormal screening lab. If the laboratory reports a single, non-clinically relevant, non-life-threatening result for any of these studies and is the only excluding factor it may be repeated 1 week later if the subject wishes. Normalization of that laboratory study will then be considered non-exclusionary.
- •Post-Radiation scarring of vocal folds.
研究组 & 干预措施
SVF for treating scarred vocal folds
Experimental
Subject identified with scarred vocal folds will have autologous adipose derived SVF harvested and applied to scarred vocal folds.
干预措施: Autologous adipose derived SVF (Biological)
结局指标
主要结局
Adverse events post SVF administration
时间窗: 24 months
Number of adverse events related to SVF via endoscopy into vocal folds defined as inflammation or swelling indicated by red or swollen vocal folds or evidence of a hemorrhage indicated by a bleed at or near the site of delivery. This will be evaluated during stroboscope exam.
次要结局
- Voice handicap Index(Baseline, Week 1, and Months 1, 3, 6, 9, 12, and 24)
研究者
Shane A. Shapiro
Regulatory Sponsor
Mayo Clinic
研究点 (1)
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