Preclinical study on safety and efficacy of GMP human umbilical cord mesenchymal stem cells in knee osteoarthritis
Clinical trials of MSCs in the treatment of OA have been carried out and good results have been obtained. However, these data on the dose of transplanted cells, the number of transplants, the therapeutic effect especially cartilage regeneration and safety are incomplete. Therefore, we constructed a cynomolgus macaque model consistent with the pathogenesis of OA. We have also established clinical-grade human umbilical cord-derived mesenchymal stem cell line. We selected two cell doses (2.5*10e7 cells per knee and 5*10e6 cells per knee, respectively) to assess differences in treatment effects and to assess the systemic safety of MSC therapy. High-dose hUC-MSCs can regenerate cartilage, increase joint space, and improve bone condition by ultrasound and MRI scans. But low-dose hUC-MSCs simply prevented further deterioration of the joint Overall design: First, we constructed a cynomolgus macaque model consistent with the pathogenesis of OA. We have also established clinical-grade human umbilical cord-derived mesenchymal stem cell line. Then we selected two cell doses (2.5*10e7 cells per knee and 5*10e6 cells per knee, respectively) to assess differences in treatment effects and to assess the systemic safety of MSC therapy. Evaluate the effectiveness of cell transplantation through ultrasound, MRI, pathology. Evaluate the safety of cell transplantation through hematological tests and CT scans. Finally, collect the joint cartilage and synovium of the higher dose transplant group, model group, and normal group of cynomolgus macaque, and analyze the treatment mechanism through 10X single-cell sequencing.