Phase 1B Study Testing Safety of E-CEL UVEC Cell Therapy to Help Heal Simple Anal Fistulas After Surgery

What this Trial Is About

Researchers are evaluating the safety of endothelial cells derived from human umbilical veins as an additional treatment alongside fistulotomy surgery for patients with simple anal fistulas. These specially engineered cells, called E-CEL UVEC, are designed to improve healing after surgery. The study aims to assess the preliminary safety of these cells and observe their effects on fistula healing, based on promising animal study results. Participants with simple anal fistulas undergoing fistulotomy may receive injections of E-CEL UVEC cells directly into the fistula area during surgery. Different parts of the study involve various treatment approaches, including injection without fistulotomy or multiple injections over several months, with doses carefully controlled. Some participants may receive up to six treatments over a six-month period, with injections targeting both sides of the fistula tract and the internal opening. During the study, participants will be monitored for safety by tracking any treatment-related adverse events within two weeks after administration. Researchers will also evaluate the rate of fistula relapse and healing success over 6 to 24 weeks after surgery. Assessments include fistula leakage and time to complete healing. The study involves regular treatment visits and follow-up assessments, with ongoing safety oversight throughout the trial period.

E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas