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DOI: 10.1055/a-2665-1777
Regenerative endoscopy for the treatment of difficult gastrointestinal defects: results from a pilot trial
Authors
Clinical Trial:
Registration number (trial ID): NCT04670276, Trial registry: ClinicalTrials.gov (http://www.clinicaltrials.gov/), Type of Study: Prospective
Abstract
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 6 mm) and 15 with rectal defects (median diameter 5 mm). 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.
Publikationsverlauf
Eingereicht: 05. März 2025
Angenommen nach Revision: 24. Juli 2025
Accepted Manuscript online:
24. Juli 2025
Artikel online veröffentlicht:
09. September 2025
© 2025. Thieme. All rights reserved.
Georg Thieme Verlag KG
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany
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