Standards of clinical-grade olfactory ensheathing cell culture and quality control (2020 China Version)

Currently, there are many different standards for the quality control of olfactory ensheathing cell (OEC) culture prepared from human olfactory bulb and mucosa. It is challenging to compare the clinical results of OEC treatment from different hospitals. Based on various standards, the Chinese Association of Neurorestoratology (CANR; Preparatory) and China Committee of International Association of Neurorestoratology (IANR-China Committee) organized professional experts in this field to evaluate the data and develop a standard for clinical applications, including donor evaluation, sample collection, cell culture, cell testing, packaging labels, storage, transportation, and quality control of intermediate/finished cell products, as well as training and management procedures for laboratory operators, the use and management of materials and equipment, and routine maintenance of a clean environment. These standards apply to the quality and control of OEC culture using human olfactory bulb and mucosa as the sample source for the member units of the CANR (Preparatory) and IANR-China Committee. It serves as a reference for physicians around the world who perform OEC clinical applications. This standard represents the minimum required standards for quality control when performing clinical-grade OEC cultures in clinical neurorestorative treatments.