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)
BackgroundAvailable 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. ObjectiveThis study aims to as...
Saved in:
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
JMIR Publications
2025-04-01
|
| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2025/1/e62659 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850151892666023936 |
|---|---|
| author | Adrien Schwitzguebel David Andres Ramirez Cadavid Tamara Da Silva Pierre Decavel Charles Benaim |
| author_facet | Adrien Schwitzguebel David Andres Ramirez Cadavid Tamara Da Silva Pierre Decavel Charles Benaim |
| author_sort | Adrien Schwitzguebel |
| collection | DOAJ |
| description |
BackgroundAvailable 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.
ObjectiveThis study aims to assess the clinical efficacy of SVF as adjuvant therapy to PRP on functionality and tissue regeneration for knee osteoarthritis.
MethodsIn 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.
ResultsParticipant 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.
ConclusionsThe 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 RegistrationClinicalTrials.gov (NCT05660824); https://clinicaltrials.gov/study/NCT05660824
International Registered Report Identifier (IRRID)PRR1-10.2196/62659 |
| format | Article |
| id | doaj-art-8bb5607e5df14ae5a30fb3c5f80b85bb |
| institution | OA Journals |
| issn | 1929-0748 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj-art-8bb5607e5df14ae5a30fb3c5f80b85bb2025-08-20T02:26:06ZengJMIR PublicationsJMIR Research Protocols1929-07482025-04-0114e6265910.2196/62659Effectiveness 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)Adrien Schwitzguebelhttps://orcid.org/0000-0002-8212-1812David Andres Ramirez Cadavidhttps://orcid.org/0000-0001-9357-529XTamara Da Silvahttps://orcid.org/0000-0002-4010-0992Pierre Decavelhttps://orcid.org/0000-0002-0567-7171Charles Benaimhttps://orcid.org/0000-0002-8999-0674 BackgroundAvailable 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. ObjectiveThis study aims to assess the clinical efficacy of SVF as adjuvant therapy to PRP on functionality and tissue regeneration for knee osteoarthritis. MethodsIn 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. ResultsParticipant 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. ConclusionsThe 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 RegistrationClinicalTrials.gov (NCT05660824); https://clinicaltrials.gov/study/NCT05660824 International Registered Report Identifier (IRRID)PRR1-10.2196/62659https://www.researchprotocols.org/2025/1/e62659 |
| spellingShingle | Adrien Schwitzguebel David Andres Ramirez Cadavid Tamara Da Silva Pierre Decavel Charles Benaim 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) JMIR Research Protocols |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| url | https://www.researchprotocols.org/2025/1/e62659 |
| work_keys_str_mv | AT adrienschwitzguebel effectivenessofstromalvascularfractionsvfandplateletrichplasmaprpinpatientswithkneeosteoarthritisprotocolforaphase3prospectiverandomizedcontrolledmulticenterstudyspoststudy AT davidandresramirezcadavid effectivenessofstromalvascularfractionsvfandplateletrichplasmaprpinpatientswithkneeosteoarthritisprotocolforaphase3prospectiverandomizedcontrolledmulticenterstudyspoststudy AT tamaradasilva effectivenessofstromalvascularfractionsvfandplateletrichplasmaprpinpatientswithkneeosteoarthritisprotocolforaphase3prospectiverandomizedcontrolledmulticenterstudyspoststudy AT pierredecavel effectivenessofstromalvascularfractionsvfandplateletrichplasmaprpinpatientswithkneeosteoarthritisprotocolforaphase3prospectiverandomizedcontrolledmulticenterstudyspoststudy AT charlesbenaim effectivenessofstromalvascularfractionsvfandplateletrichplasmaprpinpatientswithkneeosteoarthritisprotocolforaphase3prospectiverandomizedcontrolledmulticenterstudyspoststudy |