Treatment of Anal Fissure by Activated Human Macrophages
试验速览
- 阶段
- 3 期
- 试验地点
- 2
- 主要终点
- COMPLETE FISSURE HEALING
研究概览
简要总结
Chronic anal fissure is a linear tear in the distal anal canal. Most chronic fissures require intervention to heal. Surgical sphincterotomy is currently performed. However, the procedure permanently weakens the internal sphincter and may be associated with permanent complications such as incontinence. Current topical treatment or " chemical sphincterotomy" is effective in the short term for about 70% of the patient more than 50% of them will suffer from recurrence. Number of studies support the hypothesis that local ischemia is the reason for failure to heal in anal fissure. Treatment of refractory wounds by macrophage suspension is an innovative method since 1995, macrophage suspensions have been used successfully in more than 1400 patients in several hospitals in Israel without any side effect.Macrophages have key function in almost every stage of wound healing. They help in the digestion of bacteria, in a later stage, they secret IL-6, which influences endothelial cell proliferation and the initiation of angiogenesis.
The study hypothesis is that local injection of activated human macrophages into chronic anal fissure may induce fissure healing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive symptomatic adults with chronic idiopathic anal fissure
排除标准
- •Pregnant women
- •Acute fissures
- •Anal fissures of various causes ( i.e.,hemorrhoids, fistula in ano, inflammatory bowel disease)
- •Immunosuppressed patients
结局指标
主要结局
COMPLETE FISSURE HEALING
次要结局
未报告次要终点
