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Background Periodontitis results in the destruction of tooth-supporting periodontal tissue,and would not heal spontaneously.Various approaches have been introduced to regenerate periodontal tissue,however,the efficacy was limited,especially in severe cases.We studied the transplantation of autologous periodontal ligament-derived(PDL)cell sheets for the regeneration of periodontal tissue in clinical settings.Methods We performed a single-arm and single-institute phase Ⅰ study to establish the safety and efficacy of PDL cell sheets in patients with periodontitis.Wisdom teeth were extracted,and periodontal tissues were sclaped as cell sources from ten patients with severe,chronic periodontitis,ranged in age from 33 to 63 years(mean [±SD],46±12).Human cellular products were created in the cell processing center in accordance with GLP and GMP guidelines.Three-layered PDL cell sheets were constructed with temperature-responsive culture dishes and transplanted autologously following standard periodontal surgeries.Bony defects were filled with beta-tricalcium phosphate granules.Cone-beam computed tomography was performed to evaluate the periodontal regeneration at every 6 months.Results All the findings,including reduction of periodontal probing depth,clinical attachment gain,and increase of radiographic bone height,were improved in all patients.These therapeutic effects were sustained during a mean follow-up period of 36 months,and there were no complications.Conclusions The results of this study provide the safety and efficacy of PDL cell sheets.This cytotherapeutic approach might be an alternative strategy to regenerate the periodontium and improve patients quality of life.