The DOI matches its Crossref record; 88 of the 88 references it cites were found in a registry or an index.
Manufacturing of Human Extracellular Vesicle-Based Therapeutics for Clinical Use
Open accessAbstract
Extracellular vesicles (EVs) derived from stem and progenitor cells may have therapeutic effects comparable to their parental cells and are considered promising agents for the treatment of a variety of diseases. To this end, strategies must be designed to successfully translate EV research and to develop safe and efficacious therapies, whilst taking into account the applicable regulations. Here, we discuss the requirements for manufacturing, safety, and efficacy testing of EVs along their path from the laboratory to the patient. Development of EV-therapeutics is influenced by the source cell types and the target diseases. In this article, we express our view based on our experience in manufacturing biological therapeutics for routine use or clinical testing, and focus on strategies for advancing mesenchymal stromal cell (MSC)-derived EV-based therapies. We also discuss the rationale for testing MSC-EVs in selected diseases with an unmet clinical need such as critical size bone defects, epidermolysis bullosa and spinal cord injury. While the scientific community, pharmaceutical companies and clinicians are at the point of entering into clinical trials for testing the therapeutic potential of various EV-based products, the identification of the mode of action underlying the suggested potency in each therapeutic approach remains a major challenge to the translational path.
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Cited by
RNA delivery by extracellular vesicles in mammalian cells and its applications
O’Brien, K., Breyne, K., Ughetto, S., Laurent, L. C., & Breakefield, X. O. (2020) · Nature Reviews Molecular Cell Biology · doi:10.1038/s41580-020-0251-y · Cited by 1,811
Exosomes: Large-scale production, isolation, drug loading efficiency, and biodistribution and uptake
Kimiz-Gebologlu, I., & Oncel, S. S. (2022) · Journal of Controlled Release · doi:10.1016/j.jconrel.2022.05.027 · Cited by 722
Exosomes — beyond stem cells for restorative therapy in stroke and neurological injury
Zhang, Z. G., Buller, B., & Chopp, M. (2019) · Nature Reviews Neurology · doi:10.1038/s41582-018-0126-4 · Cited by 503
Mesenchymal stromal/stem cell (MSC)-Derived exosomes in clinical trials
Lotfy, A., AboQuella, N. M., & Wang, H. (2023) · Stem Cell Research & Therapy · doi:10.1186/s13287-023-03287-7 · Cited by 482
Neutrophil‐Based Drug Delivery Systems
Chu, D., Dong, X., Shi, X., Zhang, C., & Wang, Z. (2018) · Advanced Materials · doi:10.1002/adma.201706245 · Cited by 386
Metadata
- Authors
- Gimona, M., Pachler, K., Laner-Plamberger, S., Schallmoser, K., & Rohde, E.
- Venue
- International Journal of Molecular Sciences
- Publisher
- MDPI AG
- Published
- 2017-06-03
- Volume
- 18
- Issue
- 6
- Pages
- 1190
- ISSN
- 1422-0067 (ISSN-L)
- OpenAlex
- W2620679532
- Cited by
- 319
- References
- 88
- FWCI
- 9.61
- Type
- journal article
- Language
- en
- Open access
- gold
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- Gimona, M., Pachler, K., Laner-Plamberger, S., Schallmoser, K., & Rohde, E. (2017). Manufacturing of Human Extracellular Vesicle-Based Therapeutics for Clinical Use. International Journal of Molecular Sciences. https://doi.org/10.3390/ijms18061190
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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
