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Clinicians now have more alternative treatments owing to recent discoveries about and applications of many stem cell types. Direct cell transplantation has several difficulties, including unsuccessful engraftment, migration into the wounded location, loss of viability, moral dilemmas, a scarcity of donated allogeneic stem cells, and the potential for infectious disease transmission. Exosomes were discovered, and study on them has raised expectations for their use in regenerative medicine to treat a variety of diseases.

It is believed that the use of exosomes can get around a number of problems with whole-cell treatments. The exosome therapy is offered as therapeutic shots that deliver signalling molecules into the recipient cells in a paracrine fashion due to their suitable size and stability. Despite these benefits, the variation in exosomal size and payload makes exosome isolation and purification technologies tricky. The biggest obstacle preventing exosomes from being used extensively in the clinical context is the absence of standardised GMP-grade protocols.

Challenges with Exosomes

The use of exosomes for therapeutic purposes is still in its nascent stage, and if we are to establish a successful EV-based therapeutic framework, we must increase our knowledge of exosome biogenesis and address problems with their mass production and in vivo biodistribution. Predicting long-term safety and therapeutic efficacy is further challenging due to our limited grasp of the pathophysiological function of exosomes.

  • Lack of Isolation Methods
    The lack of a standardised procedure for the separation of exosomes is one of the barriers to the therapeutic use of exosomes. As major transporters of cellular information, exosomes are commonly present in the blood, saliva, urine, and other biological fluids. It is still difficult to effectively collect and separate these exosomes from various sources for clinical practice.
  • Insufficient clinical production
    A significant obstacle to the introduction of these nanosystems into clinics is the lack of a production technique that guarantees both good quality and great quantity. Researchers have put a lot of effort into obtaining GMP-grade EVs using a variety of techniques. Exosomes with therapeutic payloads must be produced sterilely using a GMP-grade manufacturing method, in adequate amounts for clinical testing, and without batch-to-batch variation that could impair efficacy.
  • Influence of Cell Culture
    Even though well-established cell lines are used, the exosome manufacturing conditions used by different laboratories vary substantially. The growth conditions employed for producer cell lines can have a significant impact on the yield and cargo of exosomes. Finding the ideal circumstances for exosome formation by a particular cell type is still difficult since they are always a compromise between the best conditions for growth and the best conditions for exosome production and isolation.

Exosome isolation does not have a “gold standard”. The results of research using EVs, particularly exosomes, remain subject to criticism, despite the fact that new technologies are being introduced and evaluated to solve this significant difficulty. Exosome research is currently constrained, but it is anticipated that this will soon change, confirming the functions of exosomes as indicators of oncoming disease states and transmitters of intercellular signalling.

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