Level A· Stronger Clinical Evidence
Cell-based versus corticosteroid injections for knee pain in osteoarthritis: a randomized phase 3 trial
Mautner K., Gottschalk M., Boden S.D., Drissi H.
A multicentre randomized trial in 480 knee osteoarthritis patients comparing SVF, BMAC and umbilical cord MSCs against corticosteroid injection. At 12 months no cell product outperformed the steroid control.
Level A· Stronger Clinical EvidenceEvidence level of this study
Relatively higher-quality human studies compared with other topics in this database, e.g. multiple RCTs or systematic reviews. This does not mean it is standard or approved care.
- Level A · Stronger Clinical Evidence
- Level B · Emerging clinical evidence with positive signals
- Level C · Early human research exploring benefits
- Level D · Scientific groundwork from lab and animal studies
- Emerging · Emerging topic under active research
- Study type
- Randomized Controlled Trial
- Journal
- Nature Medicine (2023)
- Country
- United States
- Sample size
- 480
- Follow-up
- 12 months
- PMID
- 37919438
- DOI
- 10.1038/s41591-023-02632-w
- NCT
- NCT03818737
What was studied
Safety and efficacy of three cell injection types (including SVF) versus corticosteroid injection in KL grade II–IV knee osteoarthritis.
Methods
- • Four-arm parallel, single-blind design with 3:1 randomization (cells:steroid) within each arm.
- • Co-primary endpoints were VAS pain and KOOS pain at 12 months versus baseline, with MRI osteoarthritis scoring.
Key findings
- • At one year, no orthobiologic was superior to another or to corticosteroid injection.
- • None of the four groups showed a significant change in MRI osteoarthritis score.
- • No procedure-related serious adverse events were reported.
Limitations
- • Single-blind design and only 12 months of follow-up.
- • Some investigators had disclosed financial ties to the SVF device manufacturer.
What this study does not prove
- • Does not show SVF outperforms cheaper standard steroid injection.
- • This study does not prove SVF is an approved treatment or a replacement for standard care.
- • Limited follow-up cannot indicate long-term outcomes.
Clinical interpretation
One of the highest-quality datasets available, indicating SVF was not superior to corticosteroid injection at one year.
Evidence level: Stronger Clinical Evidence