Endoscopic Injection of Autologous Fat-Derived Cells (SVF) for Adults With Refractory Gastroesophageal Reflux Disease (GERD). (The GERD-REVIVE Pilot Study) (GERD-REVIVE)
Submucosal Injection of Autologous Stromal Vascular Fraction (SVF) at the Esophagogastric Junction for the Treatment of Gastroesophageal Reflux Disease (GERD): A Single-Arm Pilot Feasibility and Safety Study
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This is a prospective, single-arm pilot study involving 15 adult patients. The intervention is performed in a single session and consists of three distinct sequential phases: Adipose Tissue Harvesting - autologous fat is obtained via a mini-subcutaneous liposuction from a suitable donor area under local anesthesia using a specialized tumescent solution. GMP-Compliant Processing (ELEA Method) - the lipoaspirate is processed in a GMP-compliant environment using mechanical activation via a Digital Vortex Mixer at 2000 rpm for 8 minutes. The resulting SVF-rich activated fat fraction is separated from the liquid and oil phases, emulsified through a 2 mm filter, and loaded into an endoscopic injection needle. Endoscopic Delivery - under direct endoscopic visualization, the activated SVF is injected circumferentially into the submucosal plane of the esophagogastric junction (EGJ), distributed across four quadrants (typically 0.5-1 cm above the squamocolumnar junction) to achieve a symmetric deposition cushion.
Schedule of Assessments and Follow-up Timeline: the total study duration for each participant is 12 months, with scheduled clinic or phone follow-up assessments at Months 1, 3, 6, and 12.
Baseline Evaluation: participants undergo a screening assessment including medical history, GERD Health-Related Quality of Life (GERD-HRQL) questionnaire, baseline upper endoscopy (EGD) with EGJ biopsies, high-resolution manometry (HRM) per Chicago v4.0, and 24-hour pH-impedance monitoring per Lyon 2.0 (performed off PPI therapy for at least 7 days).
Month 6 Evaluation: patients undergo a comprehensive objective re-evaluation including a repeat EGD with follow-up EGJ biopsies, HRM, 24-hour pH-impedance monitoring, and GERD-HRQL scoring.
Month 12 Evaluation: final clinical assessment focusing on long-term safety, adverse event reviewing, GERD-HRQL scoring, and medication status tracking (PPI discontinuation or reduction rates).
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Ivo Boskoski, Medical degree
- Numero di telefono: 06 3015 6580
- Email: ivo.boskoski@policlinicogemelli.it
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Adults 18-75 years with actionable GERD per Lyon 2.0, refractory or PPI-dependent; motility disorder
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.
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Feasibility of autologous Stromal Vascular Fraction (SVF) harvesting, processing, and endoscopic delivery
Lasso di tempo: day 0
|
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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Incidence of procedure- and product-related adverse events (AEs) and serious adverse events (SAEs)
Lasso di tempo: Up to 12 months post-procedure.
|
Safety will be assessed by recording the frequency, severity, and cumulative incidence of all local and systemic adverse events.
This includes specific monitoring for bleeding, perforation, infection, chest pain, dysphagia, stricture formation, mediastinitis, ectopic nodules, or neoplastic changes at the esophagogastric junction.
|
Up to 12 months post-procedure.
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Malattie gastrointestinali
- Malattie esofagee
- Disturbi della motilità esofagea
- Disturbi della deglutizione
- Reflusso gastroesofageo
- Tecniche e procedure diagnostiche
- Diagnosi
- Procedure chirurgiche, operative
- Procedure chirurgiche minimamente invasive
- Tecniche diagnostiche, chirurgiche
- Endoscopia
Altri numeri di identificazione dello studio
- 14201
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .