Treatment of Anal Fissure by Activated Human Macrophages

Interventional Study Clinical Trial

Official title:

Treatment of Anal Fissure by Activated Human Macrophages

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00507364
• Other study ID #: qwerty-HMO-CTIL
• Status: Not yet recruiting
• Phase: Phase 3
• First received: July 24, 2007
• Last updated: July 25, 2007

Study information

• Verified date: July 2007
• Source: Hadassah Medical Organization
• Contact: Yosef (Joseph) Lysy, MD
• Phone: 97226776848
• Email: lysy[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Local injection of activated macrophages to anal fissure

Locations

Country	Name	City	State
Israel	Hadassah University Hospital Gastroenterology Unit	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COMPLETE FISSURE HEALING