Experimental cell injection aims to heal painful anal fissures
NCT ID NCT06456073
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests whether injections of special cells (E-CEL UVEC) can safely heal chronic anal fissures that haven't responded to other treatments. Twenty adults with long-lasting anal fissures will receive the cell injection directly into the fissure. The study primarily looks at safety and whether the fissure closes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- E-CEL UVEC cells (modified human umbilical vein endothelial cells)
- What this could lead to
- If successful, this could offer a new treatment option for chronic anal fissures that haven't healed with standard therapies.
- What could go wrong
- This is a very early Phase 1 trial with only 20 participants, so safety and effectiveness are not yet proven. The treatment may cause injection site reactions or fail to heal the fissure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adults 18 years and older 2. Anterior or posterior chronic anal fissure (CAF) - chronicity defined as presence of anal fissure ≥ 6 weeks 3. Inadequate response to medical treatment of anal fissure (1 month of failed vasodilator treatment plus declined or failed botulinum injection treatment) 4. Recent history of pain on defecation at a level 4 or higher on the numerical rating scale (NRS) 5. Vital signs upon screening: * Blood pressure: systolic ≥ 90 and \< 140; and diastolic ≥ 60 and \< 90. * Breathing: ≥ 12 and ≤ 20 breaths per minute. * Pulse: ≥ 60 and ≤ 100 beats per minute. * Temperature: ≥ 97.8°F and ≤ 99.1°F (36.5°C to 37.3°C) * O2 saturation: \> 92% 6. Willing to take adequate contraceptive measures 7. Willing to sign an informed consent form and follow instructions for the trial including appearing for visits and filling out questionnaires Exclusion Criteria: 1. Lateral anal fissure 2. Presence of peri-anal or rectovaginal fistula, rectal or anal stenosis, or peri-anal abscess or non-healing peri-anal post-surgical wounds that are not anal fissures (subjects with history of anorectal surgery with healed surgical wound is not excluded) 3. Active, untreated or medically unresponsive infection of the anal fissure or fistula (e.g., erythema and pus) 4. Active systemic infection (e.g., bacteremia, sepsis) - stable, controlled and treated HIV+ subjects (e.g., recent plasma HIV RNA \<200 copies/mL) are not excluded 5. Presence of inflammatory bowel diseases (e.g., Crohn's, ulcerative colitis) 6. Taking systemic chemotherapy or local pelvic radiation treatments 7. Renal impairment defined by serum creatinine ≥ 1.5 x upper limit of normality (ULN) 8. Hepatic impairment defined by both of the following laboratory ranges: (a) total bilirubin ≥ 1.5 x ULN unless benign congenital hyperbilirubinemia; and (b) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 2.5 x ULN 9. Active alcohol or substance use that, in the opinion of the site investigator, will interfere with study follow-up. 10. Active malignant tumor (tumors must be in remission for ≥ 6 months without maintenance chemotherapy and/or radiation) 11. Ongoing or recent history (within 6 months) of abnormal, severe, progressive, or uncontrolled hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral diseases 12. Congenital immunodeficiencies 13. History of major surgery or severe trauma within the previous 3 months 14. Subjects who are actively being considered as candidates for solid organ transplantation or who may have a high likelihood of needing a solid organ transplant (ex. Progressive heart failure) 15. Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed during the study (180 days) 16. Subjects who have known hypersensitivity or documented allergy to DMSO 17. Subjects who do not wish to or cannot comply with study procedures
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Weill Cornell Medicine
RECRUITINGNew York, New York, 10065, United States
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