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Treatment of Anal Fissure by Activated Human Macrophages

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2007 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00507364
First Posted: July 26, 2007
Last Update Posted: July 26, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00507364     History of Changes
Other Study ID Numbers: qwerty-HMO-CTIL
First Submitted: July 24, 2007
First Posted: July 26, 2007
Last Update Posted: July 26, 2007
Last Verified: July 2007

Additional relevant MeSH terms:
Fissure in Ano
Anus Diseases
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases