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临床试验/NCT00507364
NCT00507364Unknown3 期

Treatment of Anal Fissure by Activated Human Macrophages

Hadassah Medical Organization2 个研究点 分布在 1 个国家开始时间: 2007年7月26日最近更新:
适应症
相关药物

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

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

研究者

申办方类型
Other

研究点 (2)

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