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

SUBMITTER: Wang J 

PROVIDER: S-EPMC9454431 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature