Interventional Study Clinical Trial
Official title:
Treatment of Anal Fissure by Activated Human Macrophages
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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