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Mesenchymal stromal cells (MSCs) have acquired an immense amount of attention across scientific and biomedical research due to their regenerative and potent immunosuppressive properties. For decades, the production of MSCs has required fidelity to quality standards and good clinical practices. These standards are necessary for ensuring reproducibility, safety, product quality, and standardization throughout the manufacturing process. Nevertheless, large-scale production of MSCs comes up with peculiar challenges and obstacles associated with the heterogeneous nature of MSCs. There are few things that you should consider while opting for Stem cell therapy, for instance, whether there are optimum facilities in the lab for cell therapy, quality standards, and Good Clinical Practice (GMP) considerations are required for mesenchymal stromal cells therapy.

Here are quality standards that you should consider before going through the process of stem cell therapy:

Cell source

Most commonly MSCs are extracted from bone marrow, umbilical cord, and adipose tissue, although they can be extracted from various adult tissue sources. It is now extensively been acknowledged that the regenerative potential of MSCs may be conditional upon the tissue source, and consequently, the question remains, whether a cell source will benefit specific medical conditions

MSC donor

MSCs can be extracted either from a  different donor (allogeneic) or from the patient’s own body (autologous). Despite the advantage of eliminating concerns with potential donor-specific immune reactions, autologous therapy holds important logistic difficulties. This is specifically essential for rapidly progressive diseases such as sepsis, critical limb ischemia, myocardial infarction, or strokes, where obstruction in cell manufacturing or quality control testing makes the clinical applicability of these donor cells unsuitable for the patients.

Large-scale culture devices

Traditionally, MSCs are expanded in 2D cell cultures but these cultures are usually tedious and require a large amount of workforce. Nowadays, a wide range of automated, closed, and high-volume cell expansion systems are available that helps in cell therapy and in the manufacturing of cell therapy products while meeting all the quality standards.

In-house facilities

Ultra-modern facilities and sterile environments are obligatory conditions for Stem cell laboratories for performing the isolation and purification of stem cells. The procedure of isolating and growing MSCs requires mastery of cell culture techniques to ensure the high quality of cells being grown. An in-house certified GMP facility along with qualified scientists is proof that sufficient expertise is being utilized in the procedure. 

Are you looking for high-quality Stem Cell Therapy?

As much as the whole procedure of extraction and purification is important, what matters is that the final product is truly the stem cells that we desire. This can be verified by performing experiments that characterize whether the cells you are using have the properties of true stem cells. The providers must mention the data for characterization in a report form. Usually, a flow cytometry-based experiment is performed that mentions the percentage of stem cell proteins that are present in your cells.

At Advancells, the best stem cell therapy center, we have a team of scientists, technicians, physicians, and stem cells experts that have years of experience and expertise in Stem cell therapy procedures. We have an ISO-compliant GMP facility of class 10,000 with ultra-modern facilities. For every patient, we provide a detailed report stating the cell viability and cell count that is verified through a third-party organization. We also provide a report of the cell characterization data through flow cytometric evaluation. 

If you still have any inquiries about stem cells procedure, please feel free to drop your queries in the comments section below or you can contact us at info@advancells.com