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
調査の概要
状態
詳細な説明
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).
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ivo Boskoski, Medical degree
- 電話番号：06 3015 6580
- メール：ivo.boskoski@policlinicogemelli.it
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Feasibility of autologous Stromal Vascular Fraction (SVF) harvesting, processing, and endoscopic delivery
時間枠：day 0
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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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of procedure- and product-related adverse events (AEs) and serious adverse events (SAEs)
時間枠：Up to 12 months post-procedure.
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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.
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Up to 12 months post-procedure.
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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