Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Editorial
. 2023 Apr 21:14:1192636.
doi: 10.3389/fimmu.2023.1192636. eCollection 2023.

Editorial: Next generation MSC therapy manufacturing, potency and mechanism of action analysis

Affiliations
Editorial

Editorial: Next generation MSC therapy manufacturing, potency and mechanism of action analysis

Raghavan Chinnadurai et al. Front Immunol. .
No abstract available

Keywords: and regeneration; cell product manufacturing; cell therapy; immunomodulation; mechanism of action (MOA); mesenchymal stromal/stem cells (MSC); potency analysis; safety and efficacy.

PubMed Disclaimer

Conflict of interest statement

SV has 60% ownership in Regulatory Cell Therapy Consultants Inc. which does not pose real or perceived conflict of interest. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Next Generation MSC Therapy Manufacturing, MoA and Potency Analysis. Next-generation MSC therapy improvements to safety and efficacy include among others: 1) Considerations on variations in the MSC source material, e.g. typically including bone marrow (BM), adipose tissue (AT), perinatal tissue (PT), and induced pluripotent stem cell (iPSC)-derived MSC products; 2) The relevant impact of donor comorbidities, e.g. the role of the body mass index (BMI), obesity, and the typically associated common comorbidities that are increasing in the population, such as type 2 diabetes (T2D) and chronic kidney disease (CKD); 3) Improved MSC product manufacturing, e.g. 2D vs. 3D expansion and in particular the anticipation of the degree of cell expansion and respective loss of potency, but also concomitant safety considerations; 4) Improved clinical delivery of MSC products, e.g. anticipating the role of cryopreservation and freeze-thawing, but also various cell priming strategies, such as cytokine and mechano-transduction licensing; and 5) Better understanding of the mechanisms of action (MoA) of MSC products in vitro and particularly in vivo in respective patients and clinical cohorts with their very own specific requirements and covariates that may confound treatment safety and efficacy; and 6) Coordinated and relevant safety, efficacy, and potency Assessment with suitable approaches, e.g. the combinatorial assay-matrix-approach, and concomitant potency screening but also potency and safety improvements.

Comment on

  • Editorial on the Research Topic Next generation MSC therapy manufacturing, potency and mechanism of action analysis

References

    1. Viswanathan S, Shi Y, Galipeau J, Krampera M, Leblanc K, Martin I, et al. . Mesenchymal stem versus stromal cells: international society for cell & gene therapy (ISCT®) mesenchymal stromal cell committee position statement on nomenclature. Cytotherapy (2019) 21:1019–24. doi: 10.1016/j.jcyt.2019.08.002 - DOI - PubMed
    1. Moll G, Hoogduijn MJ, Ankrum JA. Editorial: Safety, efficacy and mechanisms of action of mesenchymal stem cell therapies. Front Immunol (2020) 11:243. doi: 10.3389/fimmu.2020.00243 - DOI - PMC - PubMed
    1. Capilla-González V, Herranz-Pérez V, Sarabia-Estrada R, Kadri N, Moll G. Editorial: mesenchymal stromal cell therapy for regenerative medicine. Front Cell Neurosci (2022) 16. - PMC - PubMed
    1. Moll G, Ankrum JA, Kamhieh-Milz J, Bieback K, Ringdén O, Volk HD, et al. . Intravascular mesenchymal Stromal/Stem cell therapy product diversification: time for new clinical guidelines. Trends Mol Med (2019). doi: 10.1016/j.molmed.2018.12.006 - DOI - PubMed
    1. Moll G, Ankrum JA, Olson SD, Nolta JA. Improved MSC minimal criteria to maximize patient safety: a call to embrace tissue factor and hemocompatibility assessment of MSC products. Stem Cells Trans Med (2022) 11:2–13. doi: 10.1093/stcltm/szab005 - DOI - PMC - PubMed

Publication types

LinkOut - more resources