PMC:7264098 / 16999-21055 JSONTXT

{"target":"https://pubannotation.org/docs/sourcedb/PMC/sourceid/7264098","sourcedb":"PMC","sourceid":"7264098","source_url":"https://www.ncbi.nlm.nih.gov/pmc/7264098","text":"Advancing Stem Cells to Mainstream Medicines for COVID-19\nCurrently, there are 17 clinical trials investigating the therapeutic potential of MSCs in COVID-19 patients that are registered on clinicaltrials.gov website; most of these trials are either recruiting patients or have not yet started the recruitment. The vast majority of the trials are selecting patients with COVID-19 and pneumonia, and utilizing allogeneic bone-marrow or umbilical cord-derived MSCs transplanted intravenously on three different occasions (Table 1). Approximately 50% of the trials are being carried out in China. Three trials (NCT03042143 already recruiting in Northern Ireland, United Kingdom; NCT04333368 planned in France and NCT04345601 in the United States of America, not yet recruiting) aim to investigate the therapeutic potential of MSCs in SARS-CoV-2-induced ARDS. MSCs have already been investigated in ARDS both in the pre-clinical (Curley et al., 2013) and clinical settings (Wilson et al., 2015), which demonstrated the ability of MSCs to promote distal lung epithelial repair, albeit potentially limited in the presence of hypercapnic acidosis (Fergie et al., 2019).\nWhilst a number of MSC-related trials in COVID-19 patients with respiratory complications are underway, limited reports are available that these treatments have the potential to improve recovery and survival of these patients. Some encouraging data is emerging, for example in a recent study, which assessed 7 patients transplanted with intravenous MSCs (1 × 106 per kg) and 3 patients in the placebo controlled group albeit consisting of all female patients, showed significant improvement in pulmonary function and symptoms as well as substantial reduction in inflammation compared to the placebo controlled group (Figure 2).\nFigure 2 Outcomes of MSCs treatment for COVID-19 patients reported in pilot clinical trial: ChiCTR2000029990. Despite the lack of convincing evidence in support of MSC-based therapies for respiratory complications of COVID-19, a number of promising trials are currently underway, which could revolutionize the treatment prospects for severe COVID-19 patients. Regardless of the urgency of the need for MSC-based therapies for COVID-19, it is critical that the production of MSCs is in compliance with good manufacturing practices (GMP) and follows strict regulations prior to being approved for the use in humans. The use of unauthorized and unapproved stem cell therapies not validated through stringent multicenter clinical trials should be strongly discouraged. At the same time current findings imply that there is a need for globally coordinated approach and support to conduct multicenter clinical trials to demonstrate safety and effectiveness of various types of stem cells to treat COVID-19-induced health complications. It also suggests that there is a need in biomedical research and development to establish the most effective stem cell types that are ideally suited for the treatment of aforementioned complications. These developments will also require (a) GMP compliant technologies to mass produce stem cells, and (b) testing platforms that mimic human pathophysiology (e.g., 3D bioprinted organoids, organ-on-chip) to allow high-throughput screening and rapid testing of stem cells safety and efficacy.\nExtracellular vesicles (EVs) are emerging as an attractive alternative to the whole cell–based therapy. EVs have several advantages compared to the whole cell therapy including lower risk of tumorigenic effects, lower susceptibility to damage by hostile disease microenvironment and possibility for long-term storage. The long-term storage is fundamental to make the treatment accessible in developing countries and it circumvents the need to have expensive GMP cell manufacturing facilities on-site. Nevertheless, production of EVs must follow the same strict guidelines that apply to stem cells and any EV-based therapy needs to be approved by the governing bodies after being tested in clinical trials to demonstrate the safety and 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