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

Background 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 in upper and lower GI defects without additional patient risk or cost. Methods This pilot trial involved patients with GI defects accessible by endoscopy after traditional treatments had failed. The tSVFem was derived from harvested hip fat, which was processed and injected endoscopically into the defect margins. The primary outcome was complete defect resolution. Secondary outcomes included treatment frequency, procedure-related adverse events, and recurrence. Results 30 patients were included: 15 with esophageal defects (median diameter 6mm) and 15 with rectal defects (median diameter 5mm). Of the 15 esophageal defects, 14 showed complete resolution after tSVFem injection (10 after one injection and 4 after two injections). The overall resolution rate for rectal defects was 60% (six after one treatment, one after two treatments, and two after three or four treatments). The resolution rate was 5/9 for rectal defects communicating with the urinary tract and 4/6 for those communicating with other organs. No intraprocedural or postprocedural adverse events or defect recurrence occurred. Conclusions These results suggest that endoscopic injection of autologous tSVFem may treat complex esophageal and rectal defects, including those communicating with adjacent organs other than the urinary tract.