%0 Journal Article
%@ 1929-0748
%I JMIR Publications
%V 14
%N 
%P e62659
%T Effectiveness of Stromal Vascular Fraction (SVF) and Platelet-Rich Plasma (PRP) in Patients With Knee Osteoarthritis: Protocol for a Phase 3, Prospective, Randomized, Controlled, Multicenter Study (SPOST Study)
%A Schwitzguebel,Adrien
%A Ramirez Cadavid,David Andres
%A Da Silva,Tamara
%A Decavel,Pierre
%A Benaim,Charles
%+ , Sports Medicine Division, Hôpital de la Providence, Av. du Premier-Mars 29, Neuchâtel, 2000, Switzerland, 41 32 720 327, adrien.schwitzguebel@gmail.com
%K stromal vascular fraction
%K platelet-rich plasma
%K osteoarthritis
%K adjuvant therapy
%K tissue regeneration
%K clinical efficacy
%D 2025
%7 8.4.2025
%9 Protocol
%J JMIR Res Protoc
%G English
%X Background: 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. Objective: This study aims to assess the clinical efficacy of SVF as adjuvant therapy to PRP on functionality and tissue regeneration for knee osteoarthritis. Methods: 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. Results: 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. Conclusions: 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. Trial Registration: ClinicalTrials.gov (NCT05660824); https://clinicaltrials.gov/study/NCT05660824 International Registered Report Identifier (IRRID): PRR1-10.2196/62659 
%R 10.2196/62659
%U https://www.researchprotocols.org/2025/1/e62659
%U https://doi.org/10.2196/62659