Level C· Early human research exploring benefits
Safety and Tolerability of Stromal Vascular Fraction Combined with β-Tricalcium Phosphate in Posterior Lumbar Interbody Fusion: Phase I Clinical Trial
Choi U.Y., Kim K.T., Kim K.G., Han I.
Open-label phase I trial placing two cages in the same patient — one filled with β-TCP plus SVF, the other with β-TCP alone.
Level C· Early human research exploring benefitsEvidence level of this study
Early human evidence such as case series or small samples is exploring possible benefits.
- 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
- Clinical Trial
- Journal
- Cells (2020)
- Country
- South Korea
- Sample size
- 11
- Follow-up
- 12 months
- PMID
- 33049918
- DOI
- 10.3390/cells9102250
What was studied
Feasibility and safety of combining SVF with a bone graft substitute in spinal fusion surgery.
Methods
- • Fusion rate and cage subsidence assessed by X-ray and CT at 6 and 12 months.
Key findings
- • At 6 months, 54.5% of SVF cages showed fusion versus 18.2% of control cages (p = 0.151).
- • At 12 months fusion was 100% versus 91.6% (p = 0.755), with no cage subsidence.
Limitations
- • Very small sample, non-randomized and open-label.
- • Observed differences were not statistically significant.
What this study does not prove
- • Does not prove SVF significantly accelerates bone fusion.
- • 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
A preliminary safety study for SVF in spine surgery, not efficacy evidence.
Evidence level: Early human research exploring benefits