Schwitzguebel Adrien, Ramirez Cadavid David Andres, Da Silva Tamara, Decavel Pierre, Benaim Charles
Sports Medicine Division, Hôpital de la Providence, Neuchâtel, Switzerland.
GALSER SA, Neuchâtel, Switzerland.
JMIR Res Protoc. 2025 Apr 8;14:e62659. doi: 10.2196/62659.
Available evidence on the conservative treatment of knee osteoarthritis still leaves questions about the efficacy of platelet-rich plasma (PRP) and whether stromal vascular fraction (SVF) offers a superior therapeutic tool.
This study aims to assess the clinical efficacy of SVF as adjuvant therapy to PRP on functionality and tissue regeneration for knee osteoarthritis.
In a multicenter, randomized, triple-blind, controlled trial, 108 individuals with knee osteoarthritis will be block-randomized in a 1:1 ratio. Patients will receive an initial single PRP or PRP + SVF injection followed by PRP doses at 1 month and 2 months. The primary endpoint is functional improvement measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at the 6-month follow-up. Secondary endpoints, collected at the 1-month, 2-month, 3-month, 6-month, and 12-month follow-ups, will include the pain visual analogue scale during maximal physical activity, WOMAC score, length of time to return to work and sports in days, magnetic resonance imaging (MRI)-based Whole-Organ Magnetic Resonance Imaging Score (WORMS), Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score, MRI Area Measurement and Depth and Underlying Structures (AMADEUS) score at 6 months and at 12 months, adverse events, and serious adverse events.
Participant recruitment and data collection are expected to begin in July 2025 and finish in July 2027. Final end points will be gathered in August 2027, and the results are expected to be published in late 2027.
The study results will provide insight into the clinical efficacy of SVF as adjuvant therapy to PRP on functionality and tissue regeneration in patients with knee osteoarthritis.
ClinicalTrials.gov (NCT05660824); https://clinicaltrials.gov/study/NCT05660824.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/62659.
关于膝关节骨关节炎保守治疗的现有证据，仍存在富血小板血浆（PRP）疗效以及基质血管成分（SVF）是否提供更优治疗工具的问题。
本研究旨在评估SVF作为PRP辅助治疗对膝关节骨关节炎功能和组织再生的临床疗效。
在一项多中心、随机、三盲、对照试验中，108例膝关节骨关节炎患者将按1:1比例进行区组随机分组。患者将接受初始单次PRP或PRP + SVF注射，随后在1个月和2个月时注射PRP剂量。主要终点是在6个月随访时用西安大略和麦克马斯特大学骨关节炎指数（WOMAC）测量的功能改善情况。在1个月、2个月、3个月、6个月和12个月随访时收集的次要终点将包括最大体力活动时的疼痛视觉模拟量表、WOMAC评分、恢复工作和运动的天数、基于磁共振成像（MRI）的全器官磁共振成像评分（WORMS）、软骨修复组织磁共振观察（MOCART）评分、6个月和12个月时的MRI面积测量及深度和底层结构（AMADEUS）评分、不良事件和严重不良事件。
预计2025年7月开始招募参与者并收集数据，2027年7月结束。最终终点将在2027年8月收集，结果预计在2027年底发表。
研究结果将为SVF作为PRP辅助治疗对膝关节骨关节炎患者功能和组织再生的临床疗效提供见解。
ClinicalTrials.gov（NCT05660824）；https://clinicaltrials.gov/study/NCT05660824。
国际注册报告识别码（IRRID）：PRR1-10.2196/62659。
