Clinical Trial

Endoscopic Injection of Autologous Fat-Derived Cells (SVF) for Adults With Refractory Gastroesophageal Reflux Disease (GERD). (The GERD-REVIVE Pilot Study)

Study acronym: GERD-REVIVE
Not Yet Recruiting
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Summary
The purpose of this pilot clinical study is to evaluate the feasibility and safety of an innovative endoscopic treatment for adults with gastroesophageal reflux disease (GERD) that does not respond adequately to standard medications. The study focuses on the anti-reflux barrier between the esophagus and the stomach, which fails in patients with GERD. Instead of traditional surgery, this study explores a minimally invasive approach: injecting a specialized mixture of the patient's own fat-derived cells-known as the Stromal Vascular Fraction (SVF)-directly into the tissue at the esophagogastric junction during a standard endoscopy. The study is trying to answer two primary questions: Is it clinically feasible and safe to harvest, process, and endoscopically inject autologous SVF cells to support the anti-reflux barrier? Can this cell-based intervention help repair the tissue and improve the mechanical function of the barrier, allowing patients to reduce or completely stop their daily reliance on proton pump inhibitors (PPIs)? By answering these questions in a small group of 15 participants, this pilot trial aims to provide the foundational data necessary to design larger clinical studies in the future.
Trial Details
NCT Number NCT07638423
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions GERD (Gastroesophageal Reflux Disease)
Enrollment 15 participants
Start Date 2026-07
Primary Completion 2026-09 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-06-10