Phase 1b Study of E-CEL UVEC Cell Injections for Treating Chronic Anal Fissure in Adults

What this Trial Is About

Researchers are evaluating a new treatment involving E-CEL UVEC cells for adults with chronic anal fissure who have not responded to standard medical therapies. This Phase 1b trial aims to test the initial safety and potential healing effects of these genetically-engineered human umbilical vein endothelial cells injected directly around the fissure. The study is led by colorectal surgeons and seeks to observe changes in fissure healing and pain over time. Participants will receive local injections of the E-CEL UVEC cell product near the anal fissure in a series spaced 3 to 4 weeks apart. All participants receive this experimental treatment, as this is an open-label, single-arm study without a placebo group. The initial treatment and observation period lasts 6 months, followed by annual electronic questionnaires for long-term follow-up. During the study, participants will have their fissures assessed by doctors using physical examination methods accepted by the FDA. Researchers will monitor injection site reactions, pain severity during bowel movements, and wound healing progress at multiple time points up to 180 days. Safety and adverse events will be closely tracked, and participants will be asked to complete questionnaires throughout the study and during long-term follow-up.

E-CEL UVEC Treatment for Anal Fissures