Safety of Multiple Intrathecal Administrations of Cultured Human Autologous Adipose-Derived Stem Cells in the Patients with Neurological Disorders Including Parkinson’s Disease

Abstract

Although autologous adipose stem cells have much therapeutic potential for incurable diseases, safety concerns have been constantly raised for clinical use. An intrathecal injection of the stem cells to improve therapeutic efficiency in central nervous system diseases is also reluctant due to concerns of adverse reaction. To investigate the safety of multiple intrathecal administrations of autologous adipose-derived mesenchymal stem cells (hAdMSCs), adverse reactions were analyzed by questionnaire survey and blood chemistry examination in 70 patients with Parkinson’s disease and other neurodegenerative diseases who received hAdMSCs multiple times in China and Japan, retrospectively. As results, multiple IT administrations of cultured autologous hAdMSCs were safe, although mild back pain at the injection site in 4 patients and headache, dizziness, fever and asleep legs in other 4 patients. Adverse reactions were disappeared completely without specific treatment within a day. There were no serious adverse reactions during the cell treatment period. No remarkable atypical clinical change was observed in the blood analysis before and after the cell administrations. This study demonstrates that multiple IT administrations of hAdMSCs are safe for clinical use.