Clinical Evaluation of Periodontal Tissue Regeneration by ADMPC Transplantation

Objectives: We previously demonstrated that autologous transplantation of adipose tissue-derived multi-lineage progenitor cells (ADMPC) significantly induced the periodontal tissue regeneration in preclinical studies using experimental periodontitis models on beagle dogs. In this study, we evaluated the efficacy and safety of ADMPC transplantation for periodontal tissue regeneration in a clinical study.
Methods: We conducted an open-label, single-arm exploratory phase I study in accordance with the Ministry of Health, Labor and Welfare guidelines on clinical stem cell research and Act on the Safety of Regenerative Medicine. The protocol was reviewed and approved by the ethical review committee at Osaka University Dental Hospital. 12 patients who provided written informed consent were enrolled in this clinical study. ADMPC was isolated from subcutaneous adipose tissue and cultured in a cell processing isolator at Osaka University Dental Hospital. Each patient underwent flap operation in accordance with the modified Widman procedure during which autologous ADMPC were transplanted to the bone defect with a fibrin carrier material. Until 9 months after the transplantation, we performed a variety of clinical examinations including periodontal tissue inspection and standardized dental radiographic analysis.
Results: Thirty-six-week follow up demonstrated that ADMPC transplantation resulted in reduction of probing pocket depth, clinical attachment gain and neogenesis of alveolar bone. The therapeutic efficiency was observed not only in 2- or 3-walled vertical bone defects but also in more severe periodontal bone defects. In terms of safety, no transplantation-related adverse events were observed in any cases.
Conclusions: These results suggest that autologous ADMPC transplantation can induce periodontal regeneration. Further clinical study is required not only to validate the efficacy but also to reveal the indications of the ADMPC transplantation.