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Cited by 234Extracellular vesicles in diseaseMesenchymal stem cell researchTissue Engineering and Regenerative Medicine

Manufacturing and characterization of extracellular vesicles from umbilical cord-derived mesenchymal stromal cells for clinical testing

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Rohde, Eva, Pachler, Karin, Gimona, Mario·2019·Cytotherapy
DOI 10.1016/j.jcyt.2018.12.006
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Abstract

Extracellular vesicles (EVs) derived from mesenchymal stromal cells (MSCs) may deliver therapeutic effects that are comparable to their parental cells. MSC-EVs are promising agents for the treatment of a variety of diseases. To reach the intermediate goal of clinically testing safety and efficacy of EVs, strategies should strive for efficient translation of current EV research. On the basis of our in vitro an in vivo findings regarding the biological actions of EVs and our experience in manufacturing biological stem cell therapeutics for routine use and clinical testing, we discuss strategies of manufacturing and quality control of umbilical cord-derived MSC-EVs. We introduce guidelines of good manufacturing practice and their practicability along the path from the laboratory to the patient. We present aspects of manufacturing and final product quality testing and highlight the principle of "The process is the product." The approach presented in this perspective article may facilitate translational research during the development of complex biological EV-based therapeutics in a very early stage of manufacturing as well as during early clinical safety and proof-of-concept testing.

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References 50 · Cited by 234

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Authors
Rohde, E., Pachler, K., & Gimona, M.
Affiliations
Paracelsus Medical University (AT)
Corresponding author
Rohde, Eva
ORCID
Venue
Cytotherapy
Publisher
Elsevier BV
Published
2019-06
Volume
21
Issue
6
Pages
581-592
ISSN
1465-3249 (ISSN-L)
DOI
10.1016/j.jcyt.2018.12.006
OpenAlex
W2939947642
Cited by
234
References
50
Citations by year
2026: 38 · 2025: 30 · 2024: 34 · 2023: 30 · 2022: 30 · 2021: 31 · 2020: 33 · 2019: 8
FWCI
2.25
Type
journal article
Language
en
Open access
Licence
Locations
  • Cytotherapy (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
Funders
European Regional Development Fund
Topics
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Extracellular vesicles in disease
  • Health Sciences › Medicine › Genetics › Mesenchymal stem cell research
  • Health Sciences › Medicine › Surgery › Tissue Engineering and Regenerative Medicine
Keywords
extracellular vesicles, human umbilical cord mesenchymal stem cells, quality control, good manufacturing practices, stem cell therapy, clinical testing, translational research
MeSH terms
Extracellular Vesicles, Animals, Biological Products, Clinical Trials as Topic, Drug Stability, Humans, Quality Control, Umbilical Cord, Cell Culture Techniques, Mesenchymal Stem Cells

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