Manufacture and Quality Control of Human Umbilical Cord-Derived Mesenchymal Stem Cell Sheets for Clinical Use.

Abstract

Human umbilical cord-derived mesenchymal stem cell (UC−MSC) sheets have attracted much attention in cell therapy. However, the culture media and coating matrix used for the preparation of UC−MSC sheets have not been safe enough to comply with current clinical drug standards. Moreover, the UC−MSC sheet preservation systems developed before did not comply with Good Manufacturing Practice (GMP) regulations. In this study, the culture medium and coating matrix were developed for UC−MSC sheet production to comply with clinical drug standards. Additionally, the GMP-compliant preservation solution and method for the UC−MSC sheet were developed. Then, quality standards of the UC−MSC sheet were formulated according to national and international regulations for drugs. Finally, the production process of UC−MSC sheets on a large scale was standardized, and three batches of trial production were conducted and tested to meet the established quality standards. This research provides the possibility for clinical trials of UC−MSC sheet products in the development stage of new drugs and lays the foundation for industrial large-scale production after the new drug is launched.