A Retrospective Controlled Study For Treatment Of Bone Regeneration Between Rapidly Enriched Bone Marrow Mesenchymal Stem Cell-loaded Beta-Tricalcium Phosphate And Autograft Transplantation

Purpose Bone non-union after fracture,considering as a therapeutic challenge for orthopedics,the “golden standard” for treatment is autograft transplantation under stable internal fixation.However,adverse events related to autograft harvest,such as hematoma,infection,chronic pain,cannot be ignored.The application of artificial bone is rather convenient despite of its lack of osteogenesis.Bone mesenchymal stem cells(MSCs)has been proved to promoting bone regeneration by combine with certain scaffold.The study is designed to compare the promotion on bone regeneration of bone non-union between mesenchymal stem cells enriched-?-tricalcium phosphate(?-TCP)scaffold and autograft transplantation,confirming the clinical efficiency and security of bone marrow stem cell bone marrow stem cell Screen-Enrich-Combine Circulating System(SECCS)invented by our group.Methods: Patients suffered from lone bone non-union were enrolled in this retrospective casecontrolled study.Patients in the intervention group used ?-tricalcium phosphate(?-TCP)scaffold seeding with mesenchymal stem cells manufactured by SECCS as bone graft.Patients in controlled group used autograft as bone graft.All patients accepted outclinical follow up.The evaluation indicators include bone union time and radiographic union score.In addition,the validity for stem cell enrichment,enrichment efficiency and cell viability during the procedure of SECCS were tested.Results: 30 non-union patients accepted SECCS therapy and 20 non-union patients accepted autograft transplantation(AGT)were enrolled.By SECCS therapy,about 82% MSCs were enriched from bone marrow without cell viability damaged and about(11444.0±6018)MSCs were transplanted per patient.Cells adhering to ?-TCP particles were confirmed to possess ability for three-line differentiation and demonstrated highexpression of CD90(93.5%)and CD105(89.4%),and low-expression of CD34(0.1%)and CD45(0.9%).After 9 months' out-clinical follow up,27 patients in SECCS group and 18 patients in AGT group acquired clinical union with the same clinical union rate of 90.0%,there was no significant difference for clinical union time between the two groups((5.8±1.4 vs 6.8±2.0 months,P=0.064).In addition,radiographic union scores of two group both improved after surgery and it demonstrated no statistic difference at 9th month post-operation.Conclusion: the SECCS could concentrate a large proportion of MSCs from bone marrow without damage of cell viability.Bone substitutes processed by SECCS demonstrated encouraging promotion of bone regeneration and showed satisfactory clinical curative effect for diaphyseal bone non-union,non-inferiority to autograft transplantation.