E-CEL UVEC Treatment for Anal Fissures

Eligibility 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
• 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:
• 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