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Open AccessArticle

Safety and Tolerability of Stromal Vascular Fraction Combined with β-Tricalcium Phosphate in Posterior Lumbar Interbody Fusion: Phase I Clinical Trial

1
Department of Neurosurgery, School of Medicine, Kyungpook National University, Daegu 41944, Korea
2
Department of Neurosurgery, Kyungpook National University Hospital, Daegu 41566, Korea
3
Department of Biomedical Engineering, College of Medicine, Gachon University, Seongnam-si 13120, Korea
4
Department of Health Sciences and Technology, Gachon Advanced Institute for Health Sciences and Technology (GAIHST), Gachon University, Seongnam-si 13120, Korea
5
Department of Neurosurgery, CHA Bundang Medical Center, CHA University, Seongnam-si 13496, Korea
6
Department of Plastic and Reconstructive Surgery, Seoul National University Bundang Hospital, Seongnam-si 13620, Korea
*
Author to whom correspondence should be addressed.
These authors contributed equally to this work.
Cells 2020, 9(10), 2250; https://doi.org/10.3390/cells9102250
Received: 9 September 2020 / Revised: 3 October 2020 / Accepted: 6 October 2020 / Published: 8 October 2020
(This article belongs to the Special Issue Research on Adipose Stem Cells)
The rates of pseudarthrosis remain high despite recent advances in bone graft substitutes for spinal fusion surgery. The aim of this single center, non-randomized, open-label clinical trial was to determine the feasibility of combined use of stromal vascular fraction (SVF) and β-tricalcium phosphate (β-TCP) for patients who require posterior lumbar interbody fusion (PLIF) and pedicle screw fixation. Two polyetheretherketone (PEEK) cages were inserted into the intervertebral space following complete removal of the intervertebral disc. The PEEK cage (SVF group) on the right side of the patient was filled with β-TCP in combination with SVF, and the cage on the left side (control group) was filled with β-TCP alone. Fusion rate and cage subsidence were assessed by lumbar spine X-ray and CT at 6 and 12 months postoperatively. At the 6-month follow-up, 54.5% of the SVF group (right-sided cages) and 18.2% of the control group (left-sided cages) had radiologic evidence of bone fusion (p = 0.151). The 12-month fusion rate of the right-sided cages was 100%, while that of the left-sided cages was 91.6% (p = 0.755). Cage subsidence was not observed. Perioperative combined use of SVF with β-TCP is feasible and safe in patients who require spinal fusion surgery, and it has the potential to increase the early bone fusion rate following spinal fusion surgery. View Full-Text
Keywords: spinal stenosis; posterior lumbar interbody fusion; stromal vascular fraction; bone graft substitute spinal stenosis; posterior lumbar interbody fusion; stromal vascular fraction; bone graft substitute
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MDPI and ACS Style

Kim, K.-T.; Kim, K.G.; Choi, U.Y.; Lim, S.H.; Kim, Y.J.; Sohn, S.; Sheen, S.H.; Heo, C.Y.; Han, I. Safety and Tolerability of Stromal Vascular Fraction Combined with β-Tricalcium Phosphate in Posterior Lumbar Interbody Fusion: Phase I Clinical Trial. Cells 2020, 9, 2250. https://doi.org/10.3390/cells9102250

AMA Style

Kim K-T, Kim KG, Choi UY, Lim SH, Kim YJ, Sohn S, Sheen SH, Heo CY, Han I. Safety and Tolerability of Stromal Vascular Fraction Combined with β-Tricalcium Phosphate in Posterior Lumbar Interbody Fusion: Phase I Clinical Trial. Cells. 2020; 9(10):2250. https://doi.org/10.3390/cells9102250

Chicago/Turabian Style

Kim, Kyoung-Tae; Kim, Kwang G.; Choi, Un Y.; Lim, Sang H.; Kim, Young J.; Sohn, Seil; Sheen, Seung H.; Heo, Chan Y.; Han, Inbo. 2020. "Safety and Tolerability of Stromal Vascular Fraction Combined with β-Tricalcium Phosphate in Posterior Lumbar Interbody Fusion: Phase I Clinical Trial" Cells 9, no. 10: 2250. https://doi.org/10.3390/cells9102250

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