Retrospective Evaluation of Stem Cell Therapy: a Compassionate Use Program in Perianal Fistula.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Number of patients with fistula healed
研究概览
简要总结
This observational study aims at assessing the safety and efficacy profiles of mesenchymal stem cell, in different formats (SVF, autologous, allogenic), to treat complex perianal fistula according to the Spanish national Compassionate-use law .
详细描述
Under controlled circumstances, and approved by European and Spanish laws, a Compassionate-use Program allows the use of stem-cell therapy for patients with non-healing diseases, mostly complex fistula-in-ano, who do not meet criteria to be included in a clinical trial. Candidates had previously undergone multiple surgical interventions that had failed. The intervention consisted of surgery (with closure of the internal opening or a surgical flap performance), followed by stem cells injection. Three types of cells were used for implant: stromal vascular fraction, autologous expanded adipose-derived or allogenic adipose derived stem cells.
Healing was evaluated at 6th month follow-up. Outcome was classified as partial response or healing. Relapse was evaluated 1 year later. Maximum follow up period was 48 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 24 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with complex perianal fistula
- •patients who didn't meet criteria of the clinical trial (CT) in development
- •foreign patients, who were not allowed to be included in the CT
- •patients included in some CT control arms
- •failure treatment in patients included in a CT treatment arm as a retreatment
排除标准
- •not signature informed consent
结局指标
主要结局
Number of patients with fistula healed
时间窗: 12 months
Complete closure of the fistula and epithelization of the external orifice
次要结局
- Number of adversus events(12 months)