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How is the quality and safety of mesenchymal stem cells and exosomes ensured?
The objective of these tests is to ensure that the cellular product is sterile and safe for the patient, preventing the transmission of infections.
What is?
Analysis performed on the conditioned medium to detect the presence and growth of bacteria and fungi, allowing to ensure bacteriological safety.
Importance
It ensures the maximum bacteriological safety. If the mesenchymal stem cells or exosomes were contaminated with microorganisms, they could cause sepsis (severe systemic infection) or a localized infection in the patient.
What is?
Analysis aimed at detecting the presence of lipopolysaccharides (LPS), components of the outer membrane of Gram-negative bacteria, allowing to identify the presence of LPS, pyrogenic agents (capable of generating fever) that can trigger a severe systemic inflammatory response.
Importance
It allows to prevent and identify the presence of endotoxins, even if the bacteria has died, because the LPS are still potent pyrogenic agents (capable of generating fever). When they are found in high concentrations, they can trigger a severe systemic inflammatory response, high fever or, in extreme cases, septic shock in the patient.
What is?
A type of bacteria that lacks a cell wall and can contaminate cell cultures, this test allows to confirm the presence or absence of this microorganism. Its presence can alter metabolism, proliferation and function of mesenchymal stem cell mother cells (MSCs) and exosomes, compromising both therapeutic efficacy and safety.
Importance
It allows to confirm the presence or absence of this microorganism. The contamination by Mycoplasma is difficult to detect using conventional methods, as it does not produce visible turbidity. Its presence can alter metabolism, proliferation and function of mesenchymal stem cell mother cells (CMM) and exosomes, compromising both therapeutic efficacy and safety.