58 patients with Kellgren-Lawrence grades I-III osteoarthritis, normal or overweight BMI and age 55-80 years recruited. PEVs were isolated from autologous blood specimens using density gradient centrifugation in our accredited Good Manufacturing Practice(GMP) laboratory (N=17). Vesicle sizes of PEVs were characterized using transmission electron microscope. However, patients in HA group(N=20) underwent intraarticular knee injection using Hyruan One which was provided by the Life’s Good company(Korea). Control group(N=21) treated conservatively. The KOOS, WOMAC and SF36v2 questionnaires filled before treatment and one month after. Data obtained from each subscale of the questionnaires were analysed using the SPSS version-23.
No significant differences in the gender, ethnicity, BMI and OA severity between groups. In pre-test survey, groups’ scores were comparable in all subscales, except for KOOS and SF-36v2 pain, whereby the control group showed significant higher scores compared to PEV and HA groups. .
PEV group showed significant improvement after one month in the KOOS pain(P=.000), ADL(P=.001), symptoms(P=.001) and QOL(P=.000), WOMAC stiffness(P=.001) and pain(P=.034), SF-36v2 physical functioning(P=.001), pain(P=.002), physical limitation(P=.002), social functioning(P=.018) and energy(P=.002) subscales.
Comparing the groups in the post-test survey, PEV demonstrated significantly better improvement compared to control and HA groups in the KOOS pain(P=.003), symptoms(P=.044), ADL(P=.001) and QOL, (P=.001) WOMAC pain (P=.008)and SF-36v2 physical function(P=.016) subscales. PEV also showed non-statistically significant improvement in the WOMAC stiffness and SF-36v2 physical limitation subscales. These results are in contrary to study that showed blood products has no superior clinical benefits over.