Clinical cell therapy guidelines for neurorestoration (China version 2016)

Abstract

Cell therapy has been shown to be a key clinical therapeutic option for central nervous system disease or damage, and >30 types of cells have been identified through preclinical studies as having the capacity for neurorestoration. To standardize the clinical procedures of cell therapy as one of the strategies for treating neurological disorders, the first set of guidelines governing the clinical application of neurorestoration was completed in 2011 by the Chinese Branch of the International Association of Neurorestoratology. Given the rapidly advancing state of the field, the Neurorestoratology Professional Committee of Chinese Medical Doctor Association (Chinese Association of Neurorestoratology) and the Chinese Branch of the International Association of Neurorestoratology have approved the current version known as the "Clinical Cell Therapy Guidelines for Neurorestoration (China Version 2016)". We hope this guideline will reflect the most recent results demonstrated in preclinical research, transnational studies, and evidence-based clinical studies, as well as guide clinical practice in applying cell therapy for neurorestoration.

Therapeutic evidence of umbilical cord-derived mesenchymal stem cell transplantation for cerebral palsy: a randomized, controlled trial

“…When considering the transplantation route of cell therapy, intravenous administration was preferred to intrathecal injection for better compliance, since pain at the injection site was a complaint due to intrathecal administration [16]. In addition, hUC-MSCs were given at dosages of 4.5~5.5 × 10 7 cells intravenously in our study, which was supported by the suggested doses in the Clinical Cell Therapy Guidelines for Neurorestoration [47]. Moreover, repeated dosing was adopted instead of high-dosage single administration to Fig.…”

Olfactory ensheathing cell transplantation improving cerebral infarction sequela: a case report and literature review

“…In recent years, cell therapy has been proven to be a promising clinical treatment option for CNS diseases or injuries [24]. OECs transplantation has become a hotspot in the field of Neuroresotratology.…”

2018 Yearbook of Neurorestoratology

“…International Association of Neurorestoratology and the Chinese Association of Neurorestoratology proposed clinical cell therapy guidelines for neurorestoration, which included items of cell type nomenclature, cell quality control, minimal suggested cell doses, informed patients consent, indications and contraindications for undergoing cell therapy, documentation of procedure and therapy, safety & efficacy evaluations, policy of repeated treatments, no cost to patients for unproven therapies, basic principles of cell therapy, and publishing responsibility [70].…”