跳至主要内容
临床试验/NCT05709717
NCT05709717尚未招募不适用

Regenerative Therapy With Autologous Stromal Vascular Fraction Derived Mesenchymal Stem Cells and Platelet-rich Plasma to Treat Complex Perianal Diseases

Kantonsspital Winterthur KSW1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年1月25日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
Clinical Healing

研究概览

简要总结

Consecutive patients with complex anal fistula were prospectively followed for 12 months. Routine MRI was performed before and at 4 and 12 months after surgery. Continence was assessed likewise using a validated questionnaire. Fistula were drained with setons prior surgery. SVF was harvested from subcutaneous abdominal fat and PRP from peripheral blood. Distal fistulectomy to the sphincter was performed and the wound left open, while the internal orifice was closed. SVF-PRP was injected around the fistula. Patients showered their excision wound until dry. Outcomes were reported as median & interquartile range (IQR)

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Perianal fistula Perianal fissure Anovaginal fistula Rectovaginal fistula Perianal Crohn's disease

排除标准

  • 未提供

结局指标

主要结局

Clinical Healing

时间窗: 1 year

Absence of fistula opening and discharge, well-being

MRI healing

时间窗: 1year

Absence of active fistula and abscess

次要结局

  • Fecal continence(1 year)
  • Quality of life (general and related to perianal diseases)(1 year)
  • Costs(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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