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Exosomes in clinical trial and their production in compliance with good manufacturing practice


1 Bioinnovation Center, Buddhist Tzu Chi Medical Foundation; Department of Medical Research, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien, Taiwan
2 Bioinnovation Center, Buddhist Tzu Chi Medical Foundation; Department of Life Science and Graduate Institute of Biotechnology, National Dong Hwa University, Hualien, Taiwan
3 Department of Life Science and Graduate Institute of Biotechnology, National Dong Hwa University, Hualien, Taiwan
4 Bioinnovation Center, Buddhist Tzu Chi Medical Foundation; Department of Pathology, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and Tzu Chi University, Hualien, Taiwan

Correspondence Address:
Horng-Jyh Harn,
Bioinnovation Center, Buddhist Tzu Chi Medical Foundation, 707, Section 3, Chung-Yang Road, Hualien
Taiwan
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/tcmj.tcmj_182_19

Exosomes, 60-200-nm extracellular vesicles secreted from cells, have been used as an active pharmaceutical ingredient or drug carrier in disease treatment. Human- and plant-derived exosomes are registered in clinical trials, but more complete reports are available for human-derived exosomes. Because exosomes act as vesicles and carry cell secreting components, they have been used as drug or peptide vehicles to treat diseases. The dendritic cells (DCs) and mesenchymal stem cells (MSCs) are two popular cell sources for exosome preparation. Exosomes from DCs can initiate inflammation in patients, particularly in patients with cancer, as they contain the tumor antigen to induce specific inflammation response. A well-established cell bank of MSCs is available, and these cells can be used as an alternative source for exosome preparation. The major application of MSC-derived exosomes is in inflammation treatment. Exosomes in clinical trials need to comply with good manufacturing practice (GMP). Three important issues are prevalent in GMP for exosomes, i.e., upstream of cell cultivation process, downstream of the purification process, and exosome quality control. This paper concisely reviews exosome development, including exosome generation and clinical trial application.


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    -  Chen YS
    -  Lin EY
    -  Chiou TW
    -  Harn HJ
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