ACTRN12624000778583尚未招募Unknown
A human pilot study evaluating the safety of locally administered derivatives from allogeneic human amnion epithelial cells for the treatment of complex refractory perianal fistulising Crohn’s disease
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1. Adult participant
- •2. Non-active or mildly active luminal Crohn's for over 6 months defined by a Crohn's Disease Activity Index (CDAI) less than 220
- •3. Presence of complex perianal fistulas as classified by the American Gastroenterological Association (AGA)
- •4. More than 1 of the following: high intersphincteric, high trans-sphincteric, extra-sphincteric, supra-sphincteric, more than 2 external openings or associated collections
- •5. Fistulas with a maximum of 2 internal and 3 external openings
- •6. Active fistula defined as drainage and symptoms (PDAI score > 4)
- •7. Refractory to more than 1 treatment modalities such as antibiotics or immunotherapies. Definition of lack of response will assessed as per the Perianal Disease Activity Index (PDAI).
排除标准
- •1. Rectal or anal stenosis
- •2. Active severe proctitis (presence of superficial or deep ulcers)
- •3. Abscess or collection more than 2 cm size that were not properly drained
- •4. Corticosteroid use within the previous 4 weeks
- •5. Inability to tolerate or comply with trial requirements
- •6. Current pregnancy
研究者
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