National Project to Implement Mesenchymal Stem Cell for the Treatment of Perianal Crohn's Fistula (the PRIME Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 4
- 主要终点
- Therapeutic Efficacy of Darvadstrocel-MRI
研究概览
简要总结
Darvadstrocel is an expanded allogeneic adipose-derived mesenchymal stem cell therapy for the treatment of complex perianal fistulas in patients with Crohn's disease. Safety and efficacy of the procedure has been sufficiently demonstrated and the Spanish Agency of Medication approved its application a few months ago. Being aware about the difficulties to a proper application and management of the stem cells the Spanish Stem Cell therapy group devised, in a joint activity with the Spanish Group GERM (Grupo Español de Rehabilitacion Multimodal) dedicated to expand the best surgical clinical practices, a national project for the application of the therapy. The objective is to get a homogeneous implementation in all hospitals in Spain that have being baked to use this biological therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adults aged 18 years or older who have complex perianal Crohn fistula
- •non-active or mildly active luminal Crohn's disease for at least 6 months.
- •The fistula had to have been draining for at least 6 weeks before inclusion.
排除标准
- •Patient with recto-vaginal fistula; rectal or anal stenosis; or active severe proctitis.
结局指标
主要结局
Therapeutic Efficacy of Darvadstrocel-MRI
时间窗: 6 moths
MRI imaging closure of the Fistula
Therapeutic Efficacy of Darvadstrocel-Clinical
时间窗: 6 moths
Clinical closure of the Fistula
次要结局
- Quality of Life (QoL)(6 moths)
- Efficiency(6 moths)
- PATIENT REPORTED OUTCOMES (PROs)(6 moths)
研究者
Jose-M Ramirez
Profesor
Universidad de Zaragoza