Effect of the Multiple Intravenous Administration of Cultured Human Autologous Adipose-Derived Stem Cells on Tumor Biomarker Levels

Many studies have been conducted to cultivate and utilize patients’ own adipose-derived stem cells for the treatment of various incurable diseases and for regenerative medicine that can prolong lifespan. Despite the significant achievements made thus far, the lack of confidence with regard to safety, particularly the concern about Tumorigenicity, has made researchers hesitant to actively apply cultured human autologous adipose-derived cells in clinical trials. Therefore, studies on the Tumorigenicity of cultured adipose-derived stem cells are very important for expanding the field of stem cell–utilizing regenerative medicine. It is also important to study their effect on tumor biomarker levels. Long-term follow-up studies of Tumorigenicity after multiple intravenous administrations of cultured human autologous adipose-derived stem cells have not been reported worldwide. Therefore, the authors have examined about 500 Koreans who were administered more than 1 billion cultured autologous adipose-derived stem cells multiple times from 2010 to 2013 at a medical institution in Japan. We then conducted the first retrospective research in the world on the changes in eight types of tumor biomarkers over three–six years. According to the results of our analysis, there were no significant changes in the observed tumor biomarkers, irrespective of gender and age. These results suggest that multiple administrations of autologous adipose-derived stem cells cultured in accordance with the authors’ method do not affect Tumorigenicity.