MSC-Derived Exosomes for Complex Anal Fistula Treatment

This clinical trial aims to find out if injections of exosomes, which are tiny particles derived from human placenta mesenchymal stem cells, can effectively treat complex anal fistulas in adults who do not have Crohn's disease. Anal fistulas are abnormal connections between the anal canal and the skin, and they can be painful and difficult to treat. The study seeks to determine if these exosome injections can reduce the chances of the fistula coming back after treatment. It also investigates whether this new treatment is safe for patients compared to the standard surgical procedure called fistulotomy, where the fistula is surgically closed. Participants in the study will undergo the standard fistulotomy surgery, but some will also receive additional injections of MSC-derived exosomes. After the procedure, participants will have a follow-up appointment one week later and then continue with regular check-ups every four weeks. These visits are important to monitor the healing process and to check if the fistulas are recurring. The study helps to evaluate both the effectiveness and the safety of adding exosome injections to the usual surgical treatment.