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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究者
BOSKOSKI IVO
Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS