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Treatment of Anal Fissure by Activated Human Macrophages

Treatment of Anal Fissure by Activated Human Macrophages

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00507364
Enrollment
Unknown
Registered
2007-07-26
Start date
Unknown
Completion date
Unknown
Last updated
2007-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGLocal injection of activated macrophages to anal fissure

Sponsors

Hadassah Medical Organization
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years

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

Design outcomes

Primary

MeasureTime frame
COMPLETE FISSURE HEALING

Countries

Israel

Contacts

Primary ContactYosef (Joseph) Lysy, MD
lysy@hadassah.org.il97226776848

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026