An Open-Label, Single-Center, Investigator Initiated Phase 1B Trial of E-CEL UVEC Cell Therapy for the Treatment of Chronic Anal Fissure
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.
• 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