NCT00507364

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.

Trial Health

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Trial Health Score

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Geographic Reach
1 country

1 active site

Status
unknown

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2007

Completed
Last Updated

July 26, 2007

Status Verified

July 1, 2007

First QC Date

July 24, 2007

Last Update Submit

July 25, 2007

Conditions

Biological Therapy for Chronic Anal FissureTreatment by Biological Factors - Activated MacrophagesInterventional Study

Outcome Measures

Primary Outcomes (1)

  • COMPLETE FISSURE HEALING

Interventions

Local injection of activated macrophages to anal fissureDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive symptomatic adults with chronic idiopathic anal fissure

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah University Hospital Gastroenterology Unit

Jerusalem, 91120, Israel

Location

Related Publications (1)

  • 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. doi: 10.1016/s0531-5565(97)00094-6.

    PMID: 9785089RESULT

Study Officials

  • Yosef (Joseph) Lysy, MD

    Hadassah University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yosef (Joseph) Lysy, MD

CONTACT

97226776848lysy@hadassah.org.il

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 24, 2007

First Posted

July 26, 2007

Last Updated

July 26, 2007

Record last verified: 2007-07

Locations

IL(1)