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

NCT07638423 | Not Yet Recruiting

• 1 other identifier: 14201
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

GERD (Gastroesophageal Reflux Disease)

Outcome Measures

Primary Outcomes (1)

• Feasibility of autologous Stromal Vascular Fraction (SVF) harvesting, processing, and endoscopic delivery

  The proportion of participants who successfully undergo the entire procedural workflow without major protocol deviations. This includes successful mini-subcutaneous adipose tissue harvesting, GMP-compliant mechanical processing via the ELEA method, and symmetric endoscopic submucosal injection at the esophagogastric junction.

  day 0

Secondary Outcomes (1)

• Incidence of procedure- and product-related adverse events (AEs) and serious adverse events (SAEs)

  Up to 12 months post-procedure.

Study Arms (1)

Adults 18-75 years with actionable GERD per Lyon 2.0, refractory or PPI-dependent; motility disorder

EXPERIMENTAL

Eligible participants will undergo a single session of endoscopic submucosal injection of autologous, mechanically activated Stromal Vascular Fraction (SVF) at the esophagogastric junction (EGJ). The procedure consists of: Autologous adipose tissue harvesting via a mini-subcutaneous liposuction. GMP-compliant mechanical processing of the lipoaspirate using the ELEA method (vortex mixing at 2000 rpm for 8 minutes and emulsification through a 2 mm filter) to isolate the SVF-rich activated fat fraction. Direct endoscopic delivery via circumferential injections distributed across four quadrants in the submucosal plane of the EGJ (typically 0.5-1 cm above the squamocolumnar junction). Follow-up assessments will be conducted up to 12 months to evaluate safety, clinical response, and anti-reflux barrier metrics.

Procedure: Autologous Stromal Vascular Fraction (SVF) Endoscopic Injection

Interventions

Autologous Stromal Vascular Fraction (SVF) Endoscopic Injection PROCEDURE

This intervention is characterized by the localized, circumferential delivery of a point-of-care, autologous cell mixture derived from adipose tissue, distinguished by the following specific methodological parameters: Mechanical Processing (ELEA Method) - unlike chemical enzymatic digestion or standard centrifugation, the harvested fat is processed using purely mechanical activation via a Digital Vortex Mixer at 2000 rpm for exactly 8 minutes to separate the Stromal Vascular Fraction (SVF)-rich activated fat fraction. Emulsification - the isolated activated fat fraction is emulsified by mechanical passage through a dedicated 2 mm filter before being loaded into a 19-gauge endoscopic injection needle. Anatomical Site and Delivery - the cell-rich cushion is injected submucosally and symmetrically across four quadrants at the esophagogastric junction (EGJ), precisely 0.5 to 1 cm above the squamocolumnar junction, to physically and biologically augment the anti-reflux barrier.

Adults 18-75 years with actionable GERD per Lyon 2.0, refractory or PPI-dependent; motility disorder

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18-75 years; actionable GERD per Lyon 2.0 (e.g., AET \>6% off therapy; or LA grade B-D, peptic stricture, Barrett's) and compatible symptoms. \[2\]
• Refractory symptoms on optimized PPIs or PPI-dependent disease where intervention is contemplated. \[2\]
• HRM excluding major motility disorders (per Chicago v4.0). \[21\]
• Willing to undergo adipose harvest and autologous SVF therapy within a clinical trial framework.

You may not qualify if:

• Hiatal hernia \>3 cm or paraesophageal hernia; severe esophagitis with ulcers (grade B or more); Barrett's with dysplasia; strictures; achalasia/EGJOO/spastic disorders. \[2,21\]
• Coagulopathy, uncontrolled cardiopulmonary disease, pregnancy/lactation.
• Active infection/malignancy significant for increased risk, at PI discretion.
• Prior fundoplication or magnetic sphincter augmentation within 12 months.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Ivo Boskoski, Medical degree

CONTACT

06 3015 6580; ivo.boskoski@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06