Phase I Clinical Trial of UC-MSCs in the Treatment of Knee Osteoarthritis

"In this study, three dose groups are preset, which are low-dose group: 5×10\^6 cells/2.5mL; medium-dose group: 1×10\^7 cells/2.5mL; high-dose group: 2×10\^7cells/2.5mL, 9 to 18 subjects will be recruited, and will be sequential from the low-dose group to the high-dose group according to the 3+3 dose escalation principle. At least 3 subjects are enrolled in each group for the safety and tolerability test of single administration. After the last subject in each dose group completes the DLT observation period, the sponsor and the researcher jointly confirm the safety tolerance of the subjects in the previous dose group, and only after the safe tolerance is determined can the subjects enter the next dose group, so as to evaluate the safety and tolerance of human umbilical cord mesenchymal stem cell injection in the treatment of knee osteoarthritis. Recommend appropriate cell therapy dose (RP2D) for Phase II clinical trials."