Treatment of Anal Fissure by Activated Human Macrophages

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00507364
First received: July 24, 2007
Last updated: July 25, 2007
Last verified: July 2007

July 24, 2007
July 25, 2007
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COMPLETE FISSURE HEALING
Same as current
Complete list of historical versions of study NCT00507364 on ClinicalTrials.gov Archive Site
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Treatment of Anal Fissure by Activated Human Macrophages
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.

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Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Biological Therapy for Chronic Anal Fissure
  • Treatment by Biological Factors - Activated Macrophages
  • Interventional Study
Drug: Local injection of activated macrophages to anal fissure
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Danon D, Madjar J, Edinov E, Knyszynski A, Brill S, Diamantshtein L, Shinar E. Treatment of human ulcers by application of macrophages prepared from a blood unit. Exp Gerontol. 1997 Nov-Dec;32(6):633-41.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
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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
Both
18 Years to 75 Years
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Contact: Yosef (Joseph) Lysy, MD 97226776848 lysy@hadassah.org.il
Israel
 
NCT00507364
qwerty-HMO-CTIL
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Hadassah Medical Organization
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Principal Investigator: Yosef (Joseph) Lysy, MD Hadassah University Hospital
Hadassah Medical Organization
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP