SAN DIEGO—Through a fairly simple process being labeled “regenerative endoscopy,” almost 100% of patients with complex esophageal defects and 60% with rectal defects in an Italian pilot study achieved healing of long-standing complex defects previously deemed untreatable. The treatment involves simple endoscopic delivery of autologous adipose-derived tissue.
Gastrointestinal defects, such as perforations, leaks and fistulas—especially those with inflamed, fibrotic and retracted edges—often are refractory to treatment via traditional endoscopic procedures. The product—autologous adipose-derived tissue stromal vascular fraction, emulsified (tSVFem), which is rich in mesenchymal stem cells and has anti-inflammatory and regenerative tissue-promoting effects—is inexpensive to produce, and endoscopic delivery of the tissue is simple and safe, said Valerio Pontecorvi, MD, of the Fondazione Policlinico Universitario Agostino Gemelli IRCCS, in Rome, who reported the findings at DDW 2025 (abstract 675).
The results of this pilot trial evaluating the safety and efficacy of tSVFem in 30 consecutive patients with chronic upper and lower GI defects show the promise of endoscopic delivery of this product in in treating these challenging lesions, Dr. Pontecorvi said. “We enrolled patients who were deemed untreatable. These patients have very poor quality of life, and here is a treatment that can produce excellent results,” he said. “When patients are in the chronic setting, where nothing is working, I hope this can become the gold standard.”
About tSVFem
The product is obtained by mechanical emulsification of fat harvested from subcutaneous tissue from the hip or thigh. This material is sequentially passed through filters and a centrifuge before its endoscopic delivery via 22-gauge needle into the four quadrants of the fistula orifice, with the number of injections varying according to the defect size. In this study, the primary outcome was complete defect resolution, and secondary outcomes were number of treatments needed, procedure-related adverse events and recurrence.
The pilot study included 30 patients, 15 with esophageal defects (mean diameter, 6.8 mm) and 15 with rectal defects (mean diameter, 5.9 mm). The mean procedure time for both upper and lower GI fistulas was 45 minutes.
Complete Resolution In Most Patients
Success was more likely to be observed with esophageal defects than with rectal defects. Overall, 14 out of 15 patients (93.3%) with esophageal defects achieved complete resolution after tSVFem injection. Ten cases (66.6%) had complete resolution after the first tSVFem injection, and four (26.6%) achieved complete closure after the second attempt. Five patients (33.3%) had approximation of the margins with a suturing device (OverStitch, Boston Scientific), he added.
For rectal defects, nine patients (60%) achieved complete resolution of the defect, including six (40%) after one injection and three (20%) after two or more. The resolution rate for rectal defects involving the urinary tract was 55.5%, whereas the rate of defects involving other organs was 66.6%.
No intraprocedural or postprocedural adverse events or recurrent defects occurred.
“The technique has excellent results in the esophagus and good results in the rectum,” Dr. Pontecorvi said. “It is low-cost, is an easy procedure, is easily reproducible, is safe and can be adoptable in any center without advanced technologies or highly skilled staff.”
Attendees were impressed with the results. “This is a spectacular presentation,” said session co-moderator Samir Grover, MD. “Tell us when you want to run the international multicenter study. Canada will be happy to participate.”
Dr. Grover, the executive vice president of academics at the Scarborough Health Network, Scarborough Academy of Medicine and Integrated Health at the University of Toronto, told Gastroenterology & Endoscopy News, “The real reason I’m excited about this approach is that it’s available for any center to do now, provided the center is able to do the processing with respect to the tissue. [Physicians] can learn how to do this. The endoscopic learning part is quite minimal.”
—Caroline Helwick
Drs. Grover and Pontecorvi reported no relevant financial disclosures.
This article is from the October 2025 print issue.