E-CEL UVEC Treatment for Anal Fissures
ConditionChronic Anal Fissure
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWeill Medical College of Cornell University
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- E-CEL UVEC cells (AB-207)
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Weill Medical College of Cornell University
Lead sponsor
Angiocrine Bioscience
Collaborator
Source ClinicalTrials.gov