Quality Standards of Stem Cell Sources for Clinical Treatment of Neurodegenerative Diseases.

Abstract

A large number of experimental and clinical studies have shown that cell transplantation has therapeutic effects for PD, AD and other neurodegenerative diseases or damages. Good Manufacturing Practice (GMP) guidance must be defined to produce clinical-grade cellsfor transplantation to the patients. Standardized quality and clinical preparation procedures of the transplanted cells will ensure the therapeutic efficacy and reduce the side-effect risk of cell therapy. Here we review the cell quality standards governing the clinical transplantation of stem cells for neurodegenerative diseases to clinical practitioners. These quality standards include cell quality control, minimal suggested cell doses for undergoing cell transplantation, documentation of procedure and therapy, safety evaluation, efficacy evaluation, policy of repeated treatments, not charging the patients for unproven therapies, basic principles of cell therapy, and publishing responsibility.