The quality evaluation system establishment of mesenchymal stromal cells for cell-based therapy products

Abstract

Background: Cell-based therapy products are supposed to be the most complex medicine products in the history of human medical care. In this study, we established a safety evaluation system for therapeutic stromal cells based on the existing regulations and current testing techniques to provide general quality requirements for human umbilical cord mesenchymal stromal cell (HUCMSC) therapy product. Methods: In this system, we comprehensively evaluate the environmental monitoring program, quality control of critical raw materials and reagents, donor screening criteria, cell safety, quality, and biological effects, not only in line with the basic criteria of biological products, but also following the general requirements of drugs. Results: The qualified HUCMSCs were tested for various clinical researches in our hospital, and no severe adverse reaction was observed in 225 patients during a 1-year follow-up period. Conclusion: In this study, we establish a systemic quality control and potent assays to guarantee the safety and effectiveness of HUCMSCs based on a minimum set of standards in MSC-based product.

Biological characteristics of stem cells derived from burned skin—a comparative study with umbilical cord stem cells

“…Despite all advances in regenerative medicine and tissue engineering, an ideal replacement for the damaged skin, especially after large burn injuries, has yet to be discovered. Mesenchymal stromal/stem cells (MSCs) [ 1 ] are a promising source for cell-based therapies [ 2 ]. They possess an ability of self-renewal and cell differentiation, and several other unique characteristics such as secretion of paracrine factors that promote angiogenesis, reepithelialization, granulation tissue formation, and modulate inflammation [ 3 ].…”

Individual Heterogeneity Screened Umbilical Cord Derived Mesenchymal Stem Cells With High Treg Promotion Significantly Recovered the Mouse Liver Fibrosis

“…According to guidelines from Mesenchymal and Tissue Stem Cell Committee of the International Society for Cellular therapy (ISCT), MSCs have three minimal de nition criteria including adhesion to plastic, expressions of speci c surface markers (CD105, CD73, CD90, positive cells ≥ 95 %; CD45, CD34, CD14 or CD11b, CD79a or CD19, and HLA-DR negative cells ≤ 2 %), and multi-lineage differentiation potentials of adipogenesis, osteogenesis, and chondrogenesis [14]. The detailed experimental reagents and methods could be referred to our previous research [21].…”

“…In regard to multi-lineage differentiation, MSCs at the forth passage were harvested and were replated in 24-well tissue culture plate at a density of 1 × 10 4 cells /well. The detailed experimental reagents and methods could be referred to our previous research [21]. Brie y, HUCMSCs were cultured in adipogenic, osteogenic, or chondrogenic medium (Gibco, USA) to induce adipogenesis, osteogenesis or chondrogenesis for 21 days and stained with Oil red (Sigma-Aldrich, USA), Alizarin Red S (Sigma-Aldrich, USA) or Alcian Blue (Sigma-Aldrich, USA) to assess the adipogenic, osteogenic or chondrogenic differentiations, respectively.…”

One Repeated Transplantation of Allogeneic Umbilical Cord Mesenchymal Stromal Cells in Type 1 Diabetes: An Open Parallel Controlled Clinical Study

“…The MSCs were isolated from Wharton's Jelly of UC using the tissue explant method in GMP-certi ed facilities [4]. Brie y, fresh UCs were obtained from informed healthy mothers in maternity department after normal deliveries.…”

“…Due to their properties of plasticity, immunomodulatory, anti-in ammatory, and homing ability to injured sites, MSCs are well studied as a cell-based therapy for tissue degeneration and immune-based pathologies, such as graftversus-host disease, osteogenesis, cardiac disease and Crohn' disease [3]. Additionally, MSCs are easily expandable for generating su cient cell numbers, immune privileged from alloreactivity and less ethically controversial compared to other types of stem cells, therefore they are widely used in over 6000 clinical trials [4,5].…”