Regenerative endoscopy for the treatment of difficult gastrointestinal defects: results from a pilot trial.

Background and study aim Gastrointestinal (GI) defects with inflamed, fibrotic edges are often refractory to traditional endoscopic treatments. This study evaluates the efficacy and safety of endoscopically delivered stromal vascular fraction from autologous adipose tissue (tSVFem), which promotes tissue regeneration without additional patient risk or costs, for treating upper and lower GI defects. Patients and methods This pilot trial involved patients with GI defects treatable by endoscopy after traditional options failed. The tSVFem was derived from harvested hip fat, which was processed and injected into the defect margins endoscopically. The primary outcome was complete defect resolution, with secondary outcomes including treatment frequency, procedure-related adverse events, and recurrences. Results The study included 30 patients, 15 with esophageal defects (median diameter 6 mm) and 15 with rectal defects (median diameter 5 mm). Fourteen out of 15 patients with esophageal defects showed complete resolution after TSVFem injection (10after one injection and the others after two). The overall resolution rate for rectal defects was 60% (6/15 after one injection, 7/15 after two injections, 9/15 after 3-4 injections. The resolution rate for defects with the urinary tract was 5/9 , while for the four defects with other organs, it was 4/6. No intraprocedural or postprocedural adverse events or defects recurrence occurred. Conclusions These results suggest that endoscopic injection of autologous tSVFem may treat complex esophageal and rectal defects, also communicating with adjacent organs other than the urinary tract. (ClinicalTrials.gov, number: NCT04670276).