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Treatment of Anal Fissure by Activated Human Macrophages

This study is not yet open for participant recruitment.
Verified by Hadassah Medical Organization, July 2007

Sponsored by: Hadassah Medical Organization
Information provided by: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00507364
  Purpose

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.


Condition Intervention Phase
Biological Therapy for Chronic Anal Fissure
Treatment by Biological Factors - Activated Macrophages
Interventional Study
Drug: Local injection of activated macrophages to anal fissure
Phase III

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:   Treatment of Anal Fissure by Activated Human Macrophages

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • COMPLETE FISSURE HEALING

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507364

Contacts
Contact: Yosef (Joseph) Lysy, MD     97226776848     lysy@hadassah.org.il    

Locations
Israel
Hadassah University Hospital Gastroenterology Unit     Not yet recruiting
      Jerusalem, Israel, 91120
      Principal Investigator: Yosef (Joseph) Lysy, MD            

Sponsors and Collaborators
Hadassah Medical Organization

Investigators
Principal Investigator:     Yosef (Joseph) Lysy, MD     Hadassah University Hospital    
Principal Investigator:     Yosef (Joseph) Lysy, MD     Hadassah University Hospital    
  More Information


Publications of Results:

Study ID Numbers:   qwerty-HMO-CTIL
First Received:   July 24, 2007
Last Updated:   July 25, 2007
ClinicalTrials.gov Identifier:   NCT00507364
Health Authority:   Israel: Israeli Health Ministry Pharmaceutical Administration

Study placed in the following topic categories:
Fissure in Ano
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

Additional relevant MeSH terms:
Anus Diseases

ClinicalTrials.gov processed this record on October 10, 2008




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