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.
- 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