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Experimental cell injection aims to heal painful anal fissures

NCT ID NCT06456073

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Weill Cornell Medicine

    RECRUITING

    New York, New York, 10065, United States

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