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Intra-articular injection of autologous adipose-derived stromal vascular fractions for knee osteoarthritis: a double-blind randomized self-controlled trial

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Abstract

Objective

The purpose of this study was to compare the clinical and radiological efficacy of autologous adipose-derived stromal vascular fraction (SVF) versus hyaluronic acid in patients with bilateral knee osteoarthritis.

Methods

Sixteen patients with bilateral symptomatic knee osteoarthritis (K-L grade II to III; initial pain evaluated at four or greater on a ten-point VAS score) were enrolled in this study, which were randomized into two groups. Each patient received 4-ml autologous adipose-derived SVF treatment (group test, n = 16) in one side of knee joints and a single dose of 4-ml hyaluronic acid treatment (group control, n = 16) in the other side. The clinical evaluations were performed pre-operatively and post-operatively at one month, three months, six months, and 12-months follow-up visit, using the ten-point visual analog scale (VAS), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the knee range of motion (ROM). The whole-organ assessment of the knees was performed with whole-organ magnetic resonance imaging score (WORMS) based on MRI at baseline, six months and 12-months follow-up. The articular repair tissue was assessed quantitatively and qualitatively by magnetic resonance observation of cartilage repair tissue (MOCART) score based on follow-up MRI at six months and 12 months.

Results

No significant baseline differences were found between two groups. Safety was confirmed with no severe adverse events observed during 12-months follow-up. The SVF-treated knees showed significantly improvement in the mean VAS, WOMAC scores, and ROM at 12-months follow-up visit compared with the baseline. In contrast, the mean VAS, WOMAC scores, and ROM of the control group became even worse but not significant from baseline to the last follow-up visit. WORMS and MOCART measurements revealed a significant improvement of articular cartilage repair in SVF-treated knees compared with hyaluronic acid-treated knees.

Conclusion

The results of this study suggest that autologous adipose-derived SVF treatment is safe and can effectively relief pain, improve function, and repair cartilage defects in patients with knee osteoarthritis.

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Funding

This study was supported by grants from National Natural Science Foundation of China (81672769) and Medical Science and Technology Foundation of Zhejiang Province (CN) (2017KY016).

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Authors and Affiliations

  1. The Second Affiliated Hospital and Yuying Children’s Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China

    Zheping Hong, Xinji Chen & Qing Bi

  2. Department of Orthopedic Surgery, Zhejiang Provincial People’s Hospital and People’s Hospital of Hangzhou Medical College, No. 158 Shangtang Road, Hangzhou, 310014, Zhejiang, China

    Jihang Chen, Shuijun Zhang, Chen Zhao, Mingguang Bi & Qing Bi

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  1. Zheping Hong
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  2. Jihang Chen
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  6. Xinji Chen
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  7. Qing Bi
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Correspondence to Qing Bi.

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The authors declare that they have no conflicts of interest.

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All procedures performed in the studies involving human participants were in accordance with the ethical standards of Ethics Committee of the Zhejiang Provincial People’s Hospital and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. This study was registered at Chinses Clinical Trial Registry with identifier ChiCTR1800015125.

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Informed consent was obtained from all individual participants included in the study.

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Hong, Z., Chen, J., Zhang, S. et al. Intra-articular injection of autologous adipose-derived stromal vascular fractions for knee osteoarthritis: a double-blind randomized self-controlled trial. International Orthopaedics (SICOT) 43, 1123–1134 (2019). https://doi.org/10.1007/s00264-018-4099-0

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