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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Number of severe injection site reactions
Timeframe: Up to 180 days
2
Number of severe injection site reactions that are serious adverse events related to IP
Timeframe: Up to 180 days
3
Proportion of treated responders
Timeframe: Up to 180 days
Trial details
NCT IDNCT06456073
SponsorWeill Medical College of Cornell University