Toxicity, Safety, and Efficacy Studies on Mesenchymal Stem Cells Derived from Decidua basalis in Wistar Albino Rats by Intravenous and Subcutaneous Routes.

Ex vivo expanded decidua-basalis(DB)-derived mesenchymal stem cells (MSCs) obtained from single donors have demonstrated therapeutic benefits in in vitro and in vivo studies. In this report, the intravenous and subcutaneous administration of DB-MSCs obtained from five healthy donors was assessed considering clinical grade proliferation, accessibility, and toxic effects in Wistar albino rats. The ability of the obtained DB-MSCs for differentiating, as well as their expression of several cell surface markers and immunomodulatory activities, were all assessed. Clinical standard proliferated cells were administered to animals intravenously and subcutaneously in a series of preclinical models in order to assess their in vivo toxicity, general safety, and tumorigenic possibilities. We established that DB cells exhibit structural and functional traits with MSCs. At various doses supplied intravenously or subcutaneously, the research showed no fatality, abnormal response to therapy, or substantial pathological modifications in the rats. Furthermore, there was no indication of prenatal damage in the same animal species when the rats were repeatedly treated with DBMSCs. Thus, DBMSCs were demonstrated to be non-toxic, non-teratogenic, and non-tumorigenic. To determine whether they can be administrated to human patients without risk, more investigation is recommended.

Isolation, Expansion, and Characterization of Placenta Originated Decidua Basalis-Derived Mesenchymal Stromal Cells.

Mesenchymal stromal cells (MSCs) were isolated from Decidua Basalis (DB) and studied for their final cellular product measures, such as safety, purity, quality, quantity, and integrity that are ascribed as cellular products. This research aimed to isolate MSCs for expansion under the clinical scale level with potency, secretion of cytokines, growth factors secreted by DB-MSCs, and their role in wound healing. Placentas isolated from DB were expanded up to the 10th passage, and their characteristics were assessed by phenotypic characterization using a flow cytometer and analyzed for trilineage differentiation by cytochemical staining. Growth factors (GF), interleukins (IL), chemokines, and tissue inhibitors of metalloproteinases (TIMP) were measured with enzyme-linked immunosorbent assays. The harvested cells from the placenta yield 1.63-2.45 × 104cells/cm2 at P(0), 3.66-5.31 × 104cells/cm2 at P(1), 4.01-5.47 × 104cells/cm2 at P(2), and 3.94-5.60 × 104cells/cm2 at P(10) accordingly; up to 4.74 × 109 P(2) DB-MSCs were harvested within 9-11 days. The viability of the freshly harvested cells was greater than 90% in all cases. It is able to differentiate into chondrocytes, adipocytes, and osteogenic cells, proving their ability to differentiate into a trilineage. Thus, this study put an insight into a secure and conventional approach toward their ability to differentiate into multiple lineages and secrete factors related to immune regulation, making DB-MSCs a potential source in various therapeutic applications.