Treatment of Anal Fissure by Activated Human Macrophages

Phase 3

• Conditions: Biological Therapy for Chronic Anal Fissure; Treatment by Biological Factors - Activated Macrophages; Interventional Study

• Registration Number: NCT00507364
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-07
• Study First Submitted: 2007-07-24
• Study First Submitted QC: 2007-07-25
• Last Update Submitted: 2007-07-25
• Study First Posted: 2007-07-26
• Last Update Posted: 2007-07-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Consecutive symptomatic adults with chronic idiopathic anal fissure

Exclusion Criteria

• Pregnant women
• Acute fissures
• Anal fissures of various causes ( i.e.,hemorrhoids, fistula in ano, inflammatory bowel disease)
• Immunosuppressed patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
COMPLETE FISSURE HEALING

Trial Locations

Locations (1)

Hadassah University Hospital Gastroenterology Unit; 🇮🇱 Jerusalem, Israel