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

Abstract

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.

Olfactory ensheathing cell transplantation for chronic spinal cord injury: A long-term follow-up study

“…The culture medium was changed every 2-3 days and the cultures were kept in a standard humidified air incubator containing 5% CO2 and maintained at 37 °C. When the cultures research 90% confluency, the cells were passaged to attain the required number of cells for the transplantation and tested for phenotype and sterility, dissociated with accutase (Invitrogen, San Diego, CA, USA), suspended in saline at 100,000 cells/μL in saline, and tested for viability using Trypan blue exclusion to ensure that the cells were 95% viable at time of transplantation [9].…”

The 2020 Yearbook of Neurorestoratology

“…Clinical neurorestorative therapeutic guideline for brainstem hemorrhage (2020 China version) [ 80 ] provides standardization of diagnosis and neurorestorative treatments for brain stem hemorrhage. Standards of clinical-grade olfactory ensheathing cell culture and quality control (2020 China version) [ 81 ] and Standards of clinical-grade mesenchymal stromal cell preparation and quality control (2020 China version) [ 82 ] make all standardized procedures, including donor evaluation, sample collection, cell culture, cell testing, packaging marks, storage, transportation, and quality control, and also training and management procedures of laboratory operators, use and management of materials and equipment, and etc. for OECs and mesenchymal stromal cells.…”

A pilot study of clinical cell therapy for patients with vascular dementia

“…ORN and SC preparation was the same as that in our previous published paper [14]. ORN preparation and identification met the professional quality control standards of Chinese Association of Neurorestoratology (CANR; Preparatory) [15]. Olfactory receptor neurons were derived from the olfactory mucosa of an aborted fetus (an approval and signed donation consent form was first obtained) and cultured in Dulbecco's modified Eagle's medium (DMEM/F12; Gibco) with the neurotrophic factors.…”