Efficacy of Cx601 (Darvadstrocel) for the Treatment of Perianal Fistulizing Crohn's Disease - a Prospective Nationwide Multicentre Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Fistula Closure
研究概览
简要总结
The use of mesenchymal stem cells is considered a novel and promising therapeutic option for patients with perianal fistulizing Crohn's disease. However, due to limited clinical data, this multicentre, nationwide study aimed to assess its clinical efficacy in closing complex anal fistula.
详细描述
Fifteen applications in 14 patients (3 male, 11 female) with complex anal fistulas treated in three tertiary hospitals in Austria were included between October 2018 and April 2021. Injection of 120 million allogeneic expanded adipose-derived mesenchymal stem cells (Cx601 - Darvadstrocel, Alofisel®) was performed in each patient. Closure of the external fistula opening without secretion by finger compression was defined as success.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 18 and older who had a non-active or mildly active luminal CD with complex fistula with a maximum of two internal and three external fistulas
排除标准
- •rectovaginal fistulas
- •rectal and/or anal stenosis
- •active proctitis
- •diverting stomas
- •an abscess (<2cm) that was not drained at the fistula preperation visit
研究组 & 干预措施
patients with Crohn's disease and complex perianal fistula
14 patients with Crohn's disease refractory to standard treatment for complex perianal fistula got enrolled in this study.
干预措施: Darvadstrocel (Drug)
结局指标
主要结局
Fistula Closure
时间窗: 1 year
The study's primary endpoint was established at week 52 with clinically assessed fistula closure.
次要结局
- Evaluation of perianal disease(1 year)
- Evaluation of Crohn's disease(1 year)
研究者
Dr. Christopher Dawoud
Dr. med. univ.
Medical University of Vienna