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Treatment of Anal Fissure by Activated Human Macrophages

H

Hadassah Medical Center

Status and phase

Unknown
Phase 3

Conditions

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

Treatments

Drug: Local injection of activated macrophages to anal fissure

Study type

Interventional

Funder types

Other

Identifiers

NCT00507364
qwerty-HMO-CTIL

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Central trial contact

Yosef (Joseph) Lysy, MD

Data sourced from clinicaltrials.gov

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