Regenerative medicine refers to a type of therapy where cells or tissues, including bones, muscles, and tendons, are repaired following injury. These cells and tissues are generally derived from mesenchymal cells.
An ongoing challenge in the field is to identify a robust cell source and subsequently quantitatively measuring its functions and phenotype.
Leo Corps and affiliative companies offer cutting-edge assays that answer these questions, especially in regards to mesenchymal stem cells. Whether cells are used for basic scientific discovery or for therapies, it is critical to definitively characterize them.
While MSCs (mesenchymal stem cells) are able to repeatedly expand, it is recommended to use MSCs as close to the native cell as possible. MSCGlo™ Real Time can aid in characterizing your MSC cell lines. It can also aid in determining their doubling time to improve the reproducibility of your results.
We set the bar as high as possible so that researchers receive the highest quality products on the market.
While regenerative medicine remains an exciting field with enormous potential, therapies using EVs (extracellular vesicles), MSCs, HSCs (hematopoietic stem cells) or VSFs (vesicular secretome factions) are understudied. Despite the biological and regulatory complexity of these therapeutic targets, we must continue the search for scalable and reproducible purification protocols based on robust risk-based approaches. We must also elucidate the mechanisms of action through qualified potency assays in disease-relevant in vitro and in vivo models. If GMP (Good Manufacturing Practice) protocols and regulatory requirements can be applied to therapies derived from EVs, MSCs, HSCs or VSFs, we will see a spike in human clinical trials using these products. Regulatory compliance is an integral part of a stable manufacturing process, and if indeed “the process is the product,” this compliance will be critical in the large-scale pharmaceutical production with the ultimate goal of creating reproducible and effective therapies.