Hurdles to uptake of mesenchymal stem cells and their progenitors in therapeutic products

Childs, Peter G.; Reid, Stuart; Salmeron-Sanchez, Manuel; Dalby, Matthew J.

doi:10.1042/bcj20190382

Cited by 28Mesenchymal stem cell researchBiomedical Ethics and RegulationPeriodontal Regeneration and Treatments

Hurdles to uptake of mesenchymal stem cells and their progenitors in therapeutic products

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Childs, Peter G., Reid, Stuart, Salmeron-Sanchez, Manuel, Dalby, Matthew J.·2020·Biochemical Journal

DOI 10.1042/bcj20190382PMC PMC7505558

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Abstract

Twenty-five years have passed since the first clinical trial utilising mesenchymal stomal/stem cells (MSCs) in 1995. In this time academic research has grown our understanding of MSC biochemistry and our ability to manipulate these cells in vitro using chemical, biomaterial, and mechanical methods. Research has been emboldened by the promise that MSCs can treat illness and repair damaged tissues through their capacity for immunomodulation and differentiation. Since 1995, 31 therapeutic products containing MSCs and/or progenitors have reached the market with the level of in vitro manipulation varying significantly. In this review, we summarise existing therapeutic products containing MSCs or mesenchymal progenitor cells and examine the challenges faced when developing new therapeutic products. Successful progression to clinical trial, and ultimately market, requires a thorough understanding of these hurdles at the earliest stages of in vitro pre-clinical development. It is beneficial to understand the health economic benefit for a new product and the reimbursement potential within various healthcare systems. Pre-clinical studies should be selected to demonstrate efficacy and safety for the specific clinical indication in humans, to avoid duplication of effort and minimise animal usage. Early consideration should also be given to manufacturing: how cell manipulation methods will integrate into highly controlled workflows and how they will be scaled up to produce clinically relevant quantities of cells. Finally, we summarise the main regulatory pathways for these clinical products, which can help shape early therapeutic design and testing.

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Antimicrobial peptides can be effectively incorporated into orthopedic implants to reduce post-surgical infections.
“Studies suggest that antimicrobial peptides (AMPs) can be effectively incorporated into orthopedic implants to reduce post-surgical infections, yet their clinical effectiveness remains an area of ongoing investigation [115].”
From Advancements in Regenerative Therapies for Orthopedics: A Comprehensive Review of Platelet-Rich Plasma, Mesenchymal Stem Cells, Peptide Therapies, and Biomimetic Applications (2025) · cites this paper as [115]
The Introduction discusses biomaterials that support mesenchymal stem-cell viability, and Clinical application of MSCs discusses carriers that retain implanted cells. Searches for antimicrobial peptides, orthopedic implants, and post-surgical infections found no passage addressing peptide incorporation or infection reduction. (LLM, conf=0.74)
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Authors: Childs, P. G., Reid, S., Salmeron-Sanchez, M., & Dalby, M. J.
Affiliations: University of Strathclyde (GB)
Centre for the Cellular Microenvironment, Division of Biomedical Engineering, School of Engineering, College of Science and Engineering, University of Glasgow, Glasgow G12 8QQ, U.K.
University of Glasgow (GB)
Corresponding author: Dalby, Matthew J.
ORCID: Childs, Peter G.
Reid, Stuart
Dalby, Matthew J.
Venue: Biochemical Journal
Publisher: Portland Press Ltd.
Published: 2020-09-17
Volume: 477
Issue: 17
Pages: 3349-3366
ISSN: 0264-6021 (ISSN-L)
1470-8728
DOI: 10.1042/bcj20190382
PMC: PMC7505558
OpenAlex: W3087740857
Cited by: 27
References: 141
Citations by year: 2026: 4 · 2025: 7 · 2024: 4 · 2023: 2 · 2022: 5 · 2021: 5
FWCI: 0.48
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: cc-by
creativecommons.org/licenses/by/4.0/ (vor)
Locations: Biochemical Journal (publishedVersion, cc-by)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion, cc-by-sa)
Strathprints: The University of Strathclyde institutional repository (University of Strathclyde) (acceptedVersion, cc-by)
Funders: Engineering and Physical Sciences Research Council (EP/N013905/1, EP/P001114/1, EP/S02347X/1)
Biotechnology and Biological Sciences Research Council (BB/P00220X/1, BB/N018419/1, BB/N012690/1, BB/M028259/1, BB/S018808/1)
Topics: Health Sciences › Medicine › Genetics › Mesenchymal stem cell research
Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
Health Sciences › Medicine › Urology › Periodontal Regeneration and Treatments
Keywords: mesenchymal stem cells, mesenchymal progenitor cells, cell therapy products, cell manufacturing, regulatory pathways, preclinical drug development, reimbursement, immunomodulation, tissue repair, clinical trials
MeSH terms: Animals, Cell Differentiation, Humans, Immunologic Factors, Cell Proliferation, Immunomodulation, Mesenchymal Stem Cells

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