E-CEL UVEC Treatment for Anal Fissures

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:
• 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

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
• 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