Biological Therapy for Chronic Anal FissurePhase 3NCT00507364
Treatment of Anal Fissure by Activated Human Macrophages
A Phase 3 study testing Local injection of activated macrophages to anal fissure in people with Biological Therapy for Chronic Anal Fissure and Treatment by Biological Factors - Activated Macrophages, run by Hadassah Medical Organization at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biological Therapy for Chronic Anal Fissure, Treatment by Biological Factors - Activated Macrophages, Interventional Study
- What is being tested?
- Local injection of activated macrophages to anal fissure
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- Consecutive symptomatic adults with chronic idiopathic anal fissure
Who cannot join
- Pregnant women
- Acute fissures
- Anal fissures of various causes ( i.e.,hemorrhoids, fistula in ano, inflammatory bowel disease)
- Immunosuppressed patients
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah University Hospital Gastroenterology Unit
Jerusalem, 91120
Yosef (Joseph) Lysy, MD
About this study
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
- Being tested
- Local injection of activated macrophages to anal fissure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local injection of activated macrophages to anal fissureDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
COMPLETE FISSURE HEALING
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biological Therapy for Chronic Anal FissureStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Yosef (Joseph) Lysy, MD, Principal investigator, Hadassah University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507364
- Sponsor's protocol ID
- qwerty-HMO-CTIL
- Status last verified
- Jul 2007
- First submitted
- 24 Jul 2007
- Last updated
- 26 Jul 2007
- Results posted
- No
Publications
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.
PubMed 9785089
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Anal Fissure by Activated Human Macrophages
- ClinicalTrials.gov ID
- NCT00507364
- Acronym / sponsor ID
- qwerty-HMO-CTIL
- Conditions
- Biological Therapy for Chronic Anal Fissure, Treatment by Biological Factors - Activated Macrophages, Interventional Study
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- First posted
- 26 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive symptomatic adults with chronic idiopathic anal fissure
Key exclusion criteria (4 listed)
- Pregnant women
- Acute fissures
- Anal fissures of various causes ( i.e.,hemorrhoids, fistula in ano, inflammatory bowel disease)
- Immunosuppressed patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local injection of activated macrophages to anal fissure | Drug | – |
Primary outcome
COMPLETE FISSURE HEALING
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2007.
- Results publication: PubMed 9785089Danon 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yosef (Joseph) Lysy, MD principal investigator
Hadassah University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Local injection of activated macrophages to anal fissure in people with Biological Therapy for Chronic Anal Fissure and Treatment by Biological Factors - Activated Macrophages, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yosef (Joseph) Lysy, MD (97226776848, lysy@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COMPLETE FISSURE HEALING. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00507364, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2007.