RESTOREGI Study: Regenerative Endoscopic Stromal Therapy: Outcomes and Risk Factor Evaluation in GI Fistulas

RESTOREGI Study Benign gastrointestinal fistulas are abnormal communications between the gastrointestinal tract and adjacent organs or the skin. Chronic fistulas are often difficult to treat because of persistent inflammation, fibrosis, impaired vascularity, and defective tissue regeneration. Endoscopic regenerative therapy using mechanically processed autologous total stromal vascular fraction-enriched microfragmented adipose tissue (tSVF-EM) has emerged as a novel therapeutic approach that may promote tissue repair through angiogenesis, immunomodulation, and regenerative signaling. Although early clinical experience suggests promising healing outcomes, factors predicting successful fistula closure remain poorly understood. The RESTOREGI study is a prospective, single-center observational cohort study designed to identify patient-related, fistula-related, and procedural factors associated with successful healing following endoscopic tSVF-EM therapy in benign gastrointestinal fistulas. The study will also evaluate treatment safety, time to healing, recurrence rates, and the impact of procedural variables on outcomes.

NCT Number	NCT07661043
Lead Sponsor	Asian Institute of Gastroenterology, India
Conditions	Fistula, Regenerative Medicine, Stromal Vascular Fraction
Enrollment	50 participants
Start Date	2026-06-15
Primary Completion	2027-08-31 (estimated)
Study Completion	2027-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-24