MedTrace Logo

Treatment of Anal Fissure by Activated Human Macrophages

NCT00507364 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2007-07-26

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Local injection of activated macrophages to anal fissure

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Yosef (Joseph) Lysy, MD · Hadassah University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Israel

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00507364 on ClinicalTrials.gov