title: Treatment of periodontal intrabony defects using autologous periodontal ligament stem cells: a randomized clinical trial.
abstract: BACKGROUND
  Periodontitis, which progressively destroys tooth-supporting structures, is one of the most widespread infectious diseases and the leading cause of tooth loss in adults. Evidence from preclinical trials and small-scale pilot clinical studies indicates that stem cells derived from periodontal ligament tissues are a promising therapy for the regeneration of lost/damaged periodontal tissue. This study assessed the safety and feasibility of using autologous periodontal ligament stem cells (PDLSCs) as an adjuvant to grafting materials in guided tissue regeneration (GTR) to treat periodontal intrabony defects. Our data provide primary clinical evidence for the efficacy of cell transplantation in regenerative dentistry.
  
  
  METHODS
  We conducted a single-center, randomized trial that used autologous PDLSCs in combination with bovine-derived bone mineral materials to treat periodontal intrabony defects. Enrolled patients were randomly assigned to either the Cell group (treatment with GTR and PDLSC sheets in combination with Bio-oss(®)) or the Control group (treatment with GTR and Bio-oss(®) without stem cells). During a 12-month follow-up study, we evaluated the frequency and extent of adverse events. For the assessment of treatment efficacy, the primary outcome was based on the magnitude of alveolar bone regeneration following the surgical procedure.
  
  
  RESULTS
  A total of 30 periodontitis patients aged 18 to 65 years (48 testing teeth with periodontal intrabony defects) who satisfied our inclusion and exclusion criteria were enrolled in the study and randomly assigned to the Cell group or the Control group. A total of 21 teeth were treated in the Control group and 20 teeth were treated in the Cell group. All patients received surgery and a clinical evaluation. No clinical safety problems that could be attributed to the investigational PDLSCs were identified. Each group showed a significant increase in the alveolar bone height (decrease in the bone-defect depth) over time (p < 0.001). However, no statistically significant differences were detected between the Cell group and the Control group (p > 0.05).
  
  
  CONCLUSIONS
  This study demonstrates that using autologous PDLSCs to treat periodontal intrabony defects is safe and does not produce significant adverse effects. The efficacy of cell-based periodontal therapy requires further validation by multicenter, randomized controlled studies with an increased sample size.
  
  
  BACKGROUND
  NCT01357785 Date registered: 18 May 2011.
authors.affiliation: State Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical University, Xi'an, Shannxi, P. R. China. cfmsunhh@fmmu.edu.cn.
authors.forename: Fa-Ming
authors.initials: FM
authors.lastname: Chen
authors.affiliation: State Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical University, Xi'an, Shannxi, P. R. China.|State Key Laboratory of Military Stomatology, Research and Development Center for Tissue Engineering, School of Stomatology, Fourth Military Medical University, Xi'an, Shannxi, P. R. China.
authors.forename: Li-Na
authors.initials: LN
authors.lastname: Gao
authors.affiliation: State Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical University, Xi'an, Shannxi, P. R. China.
authors.forename: Bei-Min
authors.initials: BM
authors.lastname: Tian
authors.affiliation: State Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical University, Xi'an, Shannxi, P. R. China.
authors.forename: Xi-Yu
authors.initials: XY
authors.lastname: Zhang
authors.affiliation: State Key Laboratory of Military Stomatology, Research and Development Center for Tissue Engineering, School of Stomatology, Fourth Military Medical University, Xi'an, Shannxi, P. R. China.
authors.forename: Yong-Jie
authors.initials: YJ
authors.lastname: Zhang
authors.affiliation: State Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical University, Xi'an, Shannxi, P. R. China.
authors.forename: Guang-Ying
authors.initials: GY
authors.lastname: Dong
authors.affiliation: State Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical University, Xi'an, Shannxi, P. R. China.
authors.forename: Hong
authors.initials: H
authors.lastname: Lu
authors.affiliation: State Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical University, Xi'an, Shannxi, P. R. China.
authors.forename: Qing
authors.initials: Q
authors.lastname: Chu
authors.affiliation: State Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical University, Xi'an, Shannxi, P. R. China.
authors.forename: Jie
authors.initials: J
authors.lastname: Xu
authors.affiliation: State Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical University, Xi'an, Shannxi, P. R. China.|State Key Laboratory of Military Stomatology, Research and Development Center for Tissue Engineering, School of Stomatology, Fourth Military Medical University, Xi'an, Shannxi, P. R. China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Yu
authors.affiliation: State Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical University, Xi'an, Shannxi, P. R. China.
authors.forename: Rui-Xin
authors.initials: RX
authors.lastname: Wu
authors.affiliation: State Key Laboratory of Military Stomatology, Department of Periodontology, School of Stomatology, Fourth Military Medical University, Xi'an, Shannxi, P. R. China.
authors.forename: Yuan
authors.initials: Y
authors.lastname: Yin
authors.affiliation: Department of Anatomy and Cell Biology, School of Dental Medicine, University of Pennsylvania, 240 South 40th Street, Philadelphia, PA, 19104, USA. songtaos@dental.upenn.edu.
authors.forename: Songtao
authors.initials: S
authors.lastname: Shi
authors.affiliation: State Key Laboratory of Military Stomatology, Research and Development Center for Tissue Engineering, School of Stomatology, Fourth Military Medical University, Xi'an, Shannxi, P. R. China. yanjin@fmmu.edu.cn.
authors.forename: Yan
authors.initials: Y
authors.lastname: Jin
mesh_terms: D000293:Adolescent; D000328:Adult; D053687:Adult Stem Cells / Q000502:physiology; D000368:Aged; D001861:Bone Regeneration; D002478:Cells, Cultured; D005260:Female; D006801:Humans; D007571:Jaw Diseases / Q000000981:diagnostic imaging / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010513:Periodontal Ligament / Q000473:pathology; D010518:Periodontitis / Q000000981:diagnostic imaging / Q000628:therapy*; D011859:Radiography; D044968:Regenerative Medicine; D033581:Stem Cell Transplantation; D020390:Tooth Socket / Q000000981:diagnostic imaging / Q000473:pathology*; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D055815:Young Adult