Umbilical Cord‐Derived Mesenchymal Stromal Cells (MSCs) for Knee Osteoarthritis: Repeated MSC Dosing Is Superior to a Single MSC Dose and to Hyaluronic Acid in a Controlled Randomized Phase I/II Trial

摘要: Knee osteoarthritis (OA) is a leading cause of pain and disability. Although conventional treatments show modest benefits, pilot phase I/II trials with bone marrow (BM) adipose-derived (AD) mesenchymal stromal cells (MSCs) point to the feasibility, safety, occurrence clinical structural improvement in focal or diffuse disease. This study aimed assess safety efficacy intra-articular injection single repeated umbilical cord-derived (UC) MSCs knee OA. UC-MSCs were cultured an International Organization for Standardization 9001:2015 certified Good Manufacturing Practice-type Laboratory. Patients symptomatic OA randomized receive hyaluronic acid at baseline 6 months (HA, n = 8), single-dose (20 × 106 ) UC-MSC (MSC-1, 9), doses 2; MSC-2, 9). Clinical scores magnetic resonance images (MRIs) assessed throughout 12 follow-up. No severe adverse events reported. Only MSC-treated patients experienced significant function improvements from (p .001). At months, Western Ontario Mc Master Universities Arthritis Index (WOMAC-A; subscale) reached significantly lower levels MSC-2-treated group (1.1 ± 1.3) as compared HA (4.3 3.5; p .04). Pain Visual Analog scale was MSC-2 versus (2.4 2.1 vs. 22.1 9.8, .03) months. For total WOMAC, had than (4.2 3.9 15.2 11, .05). differences MRI detected. In trial (NCT02580695), treatment safe superior active comparator 1-year Stem Cells Translational Medicine 2019;8:215&224.