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Potency Assays for Mesenchymal Stromal Cell Secretome-Based Products for Tissue Regeneration

Adult stem cells maintaining tissue homeostasis and regeneration are tightly regulated by their specific microenvironments or stem cell niches. The dysfunction of niche components may alter the activity of stem cells and ultimately lead to intractable chronic or acute disorders. To overcome this dys...

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Detalles Bibliográficos
Autores principales: Sagaradze, Georgy, Monakova, Anna, Efimenko, Anastasia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10253866/
https://www.ncbi.nlm.nih.gov/pubmed/37298329
http://dx.doi.org/10.3390/ijms24119379
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author Sagaradze, Georgy
Monakova, Anna
Efimenko, Anastasia
author_facet Sagaradze, Georgy
Monakova, Anna
Efimenko, Anastasia
author_sort Sagaradze, Georgy
collection PubMed
description Adult stem cells maintaining tissue homeostasis and regeneration are tightly regulated by their specific microenvironments or stem cell niches. The dysfunction of niche components may alter the activity of stem cells and ultimately lead to intractable chronic or acute disorders. To overcome this dysfunction, niche-targeting regenerative medicine treatments such as gene, cell, and tissue therapy are actively investigated. Here, multipotent mesenchymal stromal cells (MSCs), and particularly their secretomes, are of high interest due to their potency to recover and reactivate damaged or lost stem cell niches. However, a workflow for the development of MSC secretome-based products is not fully covered by regulatory authorities, and and this issue significantly complicates their clinical translation and has possibly been expressed in a huge number of failed clinical trials. One of the most critical issues in this regard relates to the development of potency assays. In this review, guidelines for biologicals and cell therapies are considered to be applied for the development of potency assays for the MSC secretome-based products that aim for tissue regeneration. Specific attention is paid to their possible effects on stem cell niches and to a spermatogonial stem cell niche in particular.
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spelling pubmed-102538662023-06-10 Potency Assays for Mesenchymal Stromal Cell Secretome-Based Products for Tissue Regeneration Sagaradze, Georgy Monakova, Anna Efimenko, Anastasia Int J Mol Sci Review Adult stem cells maintaining tissue homeostasis and regeneration are tightly regulated by their specific microenvironments or stem cell niches. The dysfunction of niche components may alter the activity of stem cells and ultimately lead to intractable chronic or acute disorders. To overcome this dysfunction, niche-targeting regenerative medicine treatments such as gene, cell, and tissue therapy are actively investigated. Here, multipotent mesenchymal stromal cells (MSCs), and particularly their secretomes, are of high interest due to their potency to recover and reactivate damaged or lost stem cell niches. However, a workflow for the development of MSC secretome-based products is not fully covered by regulatory authorities, and and this issue significantly complicates their clinical translation and has possibly been expressed in a huge number of failed clinical trials. One of the most critical issues in this regard relates to the development of potency assays. In this review, guidelines for biologicals and cell therapies are considered to be applied for the development of potency assays for the MSC secretome-based products that aim for tissue regeneration. Specific attention is paid to their possible effects on stem cell niches and to a spermatogonial stem cell niche in particular. MDPI 2023-05-27 /pmc/articles/PMC10253866/ /pubmed/37298329 http://dx.doi.org/10.3390/ijms24119379 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Review
Sagaradze, Georgy
Monakova, Anna
Efimenko, Anastasia
Potency Assays for Mesenchymal Stromal Cell Secretome-Based Products for Tissue Regeneration
title Potency Assays for Mesenchymal Stromal Cell Secretome-Based Products for Tissue Regeneration
title_full Potency Assays for Mesenchymal Stromal Cell Secretome-Based Products for Tissue Regeneration
title_fullStr Potency Assays for Mesenchymal Stromal Cell Secretome-Based Products for Tissue Regeneration
title_full_unstemmed Potency Assays for Mesenchymal Stromal Cell Secretome-Based Products for Tissue Regeneration
title_short Potency Assays for Mesenchymal Stromal Cell Secretome-Based Products for Tissue Regeneration
title_sort potency assays for mesenchymal stromal cell secretome-based products for tissue regeneration
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10253866/
https://www.ncbi.nlm.nih.gov/pubmed/37298329
http://dx.doi.org/10.3390/ijms24119379
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