Skip to main content
Clinical Trials/NCT00507364
NCT00507364
Unknown
Phase 3

Treatment of Anal Fissure by Activated Human Macrophages

Hadassah Medical Organization1 site in 1 countryJuly 26, 2007

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Biological Therapy for Chronic Anal Fissure
Sponsor
Hadassah Medical Organization
Locations
1
Primary Endpoint
COMPLETE FISSURE HEALING
Last Updated
18 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 26, 2007
End Date
TBD
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

COMPLETE FISSURE HEALING

Study Sites (1)

Loading locations...

Similar Trials