Treatment of Anal Fissure by Activated Human Macrophages | NCT00507364

Studies
Treatment of Anal Fissure by Activated Human Macrophages

NCT00507364

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Jul 26, 2007Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

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

Interventions

Local injection of activated macrophages to anal fissure

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 24, 2007

First Submission Date that Met QC Criteria

Jul 25, 2007

First Posted Date

Jul 26, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2007

Last Update Posted Date

Jul 26, 2007Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Local injection of activated macrophages to anal fissure	Drug

Measure	Description	Time Frame
COMPLETE FISSURE HEALING

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yosef (Joseph) Lysy, MD	Contact	97226776848		lysy@hadassah.org.il

Overall Officials

Name	Affiliation	Role
Yosef (Joseph) Lysy, MD	Hadassah University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah University Hospital Gastroenterology Unit		Jerusalem		91120	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9785089	Result	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.