E-CEL UVEC Treatment for Anal Fissures

Recruiting now · Phase 1

Conditions studied: Chronic Anal Fissure

In brief

This clinical trial is being conducted by investigators who are colorectal surgeons. Eligible study participants will receive the experimental treatment E-CEL UVEC cells by direct injection into the anal fissure. The study is being conducted to determine if E-CEL UVEC cell injections will be safe and would have any effects on healing of the anal fissure.

Key facts

Study ID

NCT06456073

Run by

Weill Medical College of Cornell University

People needed

20

Starts

2024-09-12

Expected to finish

2026-12-01

Last updated by the study team

2026-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adults 18 years and older
• Anterior or posterior chronic anal fissure (CAF) - chronicity defined as presence of anal fissure ≥ 6 weeks
• Inadequate response to medical treatment of anal fissure (1 month of failed vasodilator treatment plus declined or failed botulinum injection treatment)
• Recent history of pain on defecation at a level 4 or higher on the numerical rating scale (NRS)
• 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%
• Willing to take adequate contraceptive measures
• Willing to sign an informed consent form and follow instructions for the trial including appearing for visits and filling out questionnaires

You may not qualify if…

• Lateral anal fissure
• 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)
• Active, untreated or medically unresponsive infection of the anal fissure or fistula (e.g., erythema and pus)
• 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
• Presence of inflammatory bowel diseases (e.g., Crohn's, ulcerative colitis)
• Taking systemic chemotherapy or local pelvic radiation treatments
• Renal impairment defined by serum creatinine ≥ 1.5 x upper limit of normality (ULN)
• 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
• Active alcohol or substance use that, in the opinion of the site investigator, will interfere with study follow-up.
• Active malignant tumor (tumors must be in remission for ≥ 6 months without maintenance chemotherapy and/or radiation)
• Ongoing or recent history (within 6 months) of abnormal, severe, progressive, or uncontrolled hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral diseases
• Congenital immunodeficiencies
• History of major surgery or severe trauma within the previous 3 months
• 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)
• Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed during the study (180 days)
• Subjects who have known hypersensitivity or documented allergy to DMSO
• Subjects who do not wish to or cannot comply with study procedures

Where it is running

• Weill Cornell Medicine — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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