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Gene & Protein in Disease Stem cell-based antimicrobial therapy

promoting tissue healing can be assessed in animal models. cultural milieu, growth stimulants, and cellular concentration
The aforementioned studies have the potential to furnish may give rise to variations in the caliber and potency of
significant insights regarding the safety and effectiveness stem cells, thereby constraining the efficaciousness of stem
of stem cell treatments before their clinical trials on human cell treatments. In response to this challenge, scholars are
subjects . The efficacy of stem cell-derived antimicrobial currently devising technological solutions to mechanize
[64]
[69]
therapies in the treatment of human infections can be and regulate the production procedures of stem cells .
assessed through clinical trials. Clinical trials can offer The utilization of bioreactors, microcarrier systems, and
significant insights into the safety and effectiveness of stem closed-system processing has been shown to enhance the
cell treatments in human subjects, thereby contributing uniformity and efficacy of stem cell manufacturing.
to the advancement of stem cell-based antimicrobial Furthermore, investigators are examining the potential
therapies . The process of developing and translating stem of allogeneic stem cells, which can be generated in
[65]
cell-based antimicrobial therapies necessitates the crucial significant quantities from a solitary donor and employed
undertaking of safety and efficacy testing. By guaranteeing to address numerous patients. The utilization of allogeneic
the safety and effectiveness of these therapies, it is possible stem cells has the potential to decrease the requirement for
to create new and efficient treatments for infections that autologous stem cells, which necessitate extraction from the
exhibit resistance to conventional antibiotics. patient’s own tissues and can be a laborious and expensive
Stem cell-based antimicrobial therapies are subject process . The scalability of manufacturing is a crucial
[70]
to regulatory oversight by government agencies such as factor to be taken into account in the advancement and
the U.S. Food and Drug Administration (FDA) and the implementation of antimicrobial therapies based on stem
European Medicines Agency . The aforementioned cells. Through the optimization of stem cell manufacturing
[66]
organizations are responsible for monitoring the procedures and the advancement of technologies that
development, production, and medical application of stem automate and standardize these procedures, it is possible to
cell-based therapies to ensure their safety and efficacy. generate significant quantities of stem cells while preserving
Stem cell-based antimicrobial medicines are governed by their quality and effectiveness.
the FDA in the U.S. as biological products. To guarantee
the consistency and excellence of the manufacturing 5. Current and future applications of stem
processes, the FDA mandates that the aforementioned cell antimicrobial therapy
items be produced in compliance with the current good Insights into the safety and efficacy of stem cell-based
manufacturing practices . The FDA also mandates that antimicrobial therapies have been obtained through
[67]
clinical trials for stem cell-based treatments be carried preclinical and clinical studies. Various investigations
out under an investigational new drug application. Data have examined diverse stem cell varieties, modes of
proving the safety and effectiveness of the therapy must be administration, and antimicrobial objectives to establish
submitted to do this. innovative and efficacious therapies for antibiotic-resistant

The issue of scalability in manufacturing holds infections. An instance of a preclinical investigation
significant importance in the context of the advancement involves the utilization of MSCs for the treatment of
of antimicrobial therapies based on stem cells. As these bacterial infections. MSCs have demonstrated the ability
therapeutic interventions transition from preclinical to mitigate inflammation, enhance bacterial elimination,
stages to clinical trials and eventual commercialization, it and facilitate tissue regeneration in animal models of
becomes imperative to scale up their production to cater bacterial infections [71,72] . It is believed that the impacts
to the growing demand for treatment . The concept are facilitated through the immunomodulatory and
[68]
of manufacturing scalability pertains to the creation of antimicrobial characteristics of MSCs.
procedures and innovations that can be expanded to An instance of preclinical research involves the
generate substantial volumes of stem cells, while ensuring utilization of neural stem cells for the purpose of treating
the preservation of their quality and effectiveness. The viral infections. Studies conducted on animal models have
optimization of protocols for stem cell isolation, expansion, demonstrated that neural stem cells possess the ability
and delivery is necessary to ensure their efficient and to facilitate viral clearance and mitigate inflammation in
consistent performance on a large scale. the brain during viral infections. It is believed that the
The manufacturing scalability of stem cell-based immunomodulatory and neuroprotective properties of
antimicrobial therapies is hindered by the potential neural stem cells are responsible for these observed effects.
variability in stem cell quality and efficacy that may arise Apart from preclinical investigations, human clinical trials
during the process of large-scale production. Disparities in have been carried out to assess the safety and effectiveness

Volume 2 Issue 4 (2023) 8 https://doi.org/10.36922/gpd.1230