Background: The purpose of this study was to evaluate the clinical results following intra-articular knee injection of Stromal Vascular Fraction (SVF cell therapy).
Methods: This study involved 13 consecutive patients who had received SVF cell therapy at our clinic before November 2015 and completed the 6-month post-treatment follow-up period. For each treatment, approximately 200 mL or more of subcutaneous adipose tissue was harvested using tumescent liposuction technique and manual aspiration of tissue from the lower abdomen using a suction cannula under local anesthesia in the operating room. The adipose tissue harvested was processed using the Celution Centrifuge IV in the cell processing room of our clinic. These cells were injected into the articular cavity of both knees directly. Outcome was assessed on the basis of patient questionnaires using VAS for pain, the Japanese Knee Osteoarthritis Measure (JKOM), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Results: The 13 patients (26 knee joints), consisting of 2 men and 11 women, had a mean age of 74.5 ± 5.4 years. Eleven patients (9 women, 2 men) presented Grade IV knee OA according to the KL classification. The remaining two patients, both women, had Grade III. Pre-operative scores of JKOM, WOMAC, VAS, and BS-POP (for patients) were 55.9 ± 21.0, 49.6 ± 20.4, 72.7 ± 18.2, and 18.5 ± 2.0. No serious adverse events were reported. One month after injection of SVF, all the scores of JKOM, WOMAC, and VAS were significantly improved over baseline (P < 0.01). Ultimately, the scores were improved by an average of 35% over baseline for JKOM, 32% improvement in WOMAC, and 40% for pain (VAS).
Conclusions: Our approach is unique in that it occurred within the context of the recently enacted Japanese Regenerative Medicine Safety Act which is the first in the world.
Keywords: Adipose-derived mesenchymal stem cell (MSC); Knee osteoarthritis; Regenerative medicine safety act in Japan; Stromal vascular fraction (SVF); Type II regenerative medicine provision plan.