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Treatment of Anal Fissure by Activated Human Macrophages

Primary Purpose

Biological Therapy for Chronic Anal Fissure, Treatment by Biological Factors - Activated Macrophages, Interventional Study

Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Local injection of activated macrophages to anal fissure
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biological Therapy for Chronic Anal Fissure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Hadassah University Hospital Gastroenterology Unit

Outcomes

Primary Outcome Measures

COMPLETE FISSURE HEALING

Secondary Outcome Measures

Full Information

First Posted
July 24, 2007
Last Updated
July 25, 2007
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00507364
Brief Title
Treatment of Anal Fissure by Activated Human Macrophages
Official Title
Treatment of Anal Fissure by Activated Human Macrophages
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biological Therapy for Chronic Anal Fissure, Treatment by Biological Factors - Activated Macrophages, Interventional Study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Local injection of activated macrophages to anal fissure
Primary Outcome Measure Information:
Title
COMPLETE FISSURE HEALING

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yosef (Joseph) Lysy, MD
Phone
97226776848
Email
lysy@hadassah.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yosef (Joseph) Lysy, MD
Organizational Affiliation
Hadassah University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah University Hospital Gastroenterology Unit
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yosef (Joseph) Lysy, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
9785089
Citation
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.
Results Reference
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Treatment of Anal Fissure by Activated Human Macrophages

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