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