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Int. J. Mol. Sci. 2017, 18(6), 1190; doi:10.3390/ijms18061190

Manufacturing of Human Extracellular Vesicle-Based Therapeutics for Clinical Use

1
GMP Unit, Spinal Cord Injury and Tissue Regeneration Center Salzburg (SCI-TReCS), Paracelsus Medical University (PMU), 5020 Salzburg, Austria
2
Research Program Nanovesicular Therapies, Paracelsus Medical University (PMU), 5020 Salzburg, Austria
3
Department of Blood Group Serology and Transfusion Medicine, Paracelsus Medical University (PMU), 5020 Salzburg, Austria
*
Author to whom correspondence should be addressed.
Academic Editor: Thomas Ritter
Received: 10 May 2017 / Revised: 29 May 2017 / Accepted: 31 May 2017 / Published: 3 June 2017
View Full-Text   |   Download PDF [261 KB, uploaded 12 June 2017]

Abstract

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. View Full-Text
Keywords: extracellular vesicles; exosomes; vesicular secretome fraction; mesenchymal stromal cells; therapeutics; critical size bone defect; epidermolysis bullosa; spinal cord injury; good manufacturing practice extracellular vesicles; exosomes; vesicular secretome fraction; mesenchymal stromal cells; therapeutics; critical size bone defect; epidermolysis bullosa; spinal cord injury; good manufacturing practice
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

Gimona, M.; Pachler, K.; Laner-Plamberger, S.; Schallmoser, K.; Rohde, E. Manufacturing of Human Extracellular Vesicle-Based Therapeutics for Clinical Use. Int. J. Mol. Sci. 2017, 18, 1190.

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