Considerations of Quality Control Issues for the Mesenchymal Stem Cells-Based Medicinal Products

Abstract

Mesenchymal stem cells (MSCs) represent a potentially attractive product for achieving successful stem-cell-based therapy. Clinical application studies of the MSCs for a variety of diseases such as graft-versus-host disease, liver fibrosis, heart disease, diabetes, osteoarthritis, and spinal cord injury have been proposed worldwide. While clinical applications of MSC-based therapy (MSCT) increasingly gain popularity among clinical practitioners and researchers, concerns have been raised on quality issues of MSCs among all stem cell-based medicinal products (SCMP). Quality issues are associated with donor's qualification and in vitro cell processing as well as some still unknown biological characteristics of the MSCs, especially in the context of potential tumorigenicity. Quality issues could affect safety and efficacy of the MSCT. To ensure optimal quality assurance for both safety and efficacy of the stem cell-based therapy in clinical trials, processes for SCMP production, quality control tests are necessary at each step. More specifically, donor identity, stem cell tissue origins, purity, safety, potency, and stability, must be strictly controlled during the entire product development cycle.