PMC:7144273 / 30047-35458 JSONTXT

{"target":"https://pubannotation.org/docs/sourcedb/PMC/sourceid/7144273","sourcedb":"PMC","sourceid":"7144273","source_url":"https://www.ncbi.nlm.nih.gov/pmc/7144273","text":"Clinical investigations of MSC administration in patients with coronavirus or other respiratory virus-induced lung injury\nDespite suggestive recent evidence of potential efficacy of MSC administration in pre-clinical models of influenza respiratory viral lung infections, there are limited published clinical data available. A recently published single-centre open-label pilot investigation from the YouAn Hospital in Beijing (China) administered BM-MSCs to seven patients with COVID-19 pneumonia with differing degrees of severity including one patient with critically severe disease requiring care in the intensive care unit (ICU) [47]. The MSCs were given as a single intravenous administration at a dose of 106 cells·kg−1 body weight in 100 mL saline at various times after initial symptomatic presentation. The MSCs were assessed by RNA sequencing for expression of ACE2 or TMPRSS2 prior to administration and each was found to be minimally expressed (in one out of 12 500 cells and seven out of 12 500 cells, respectively), although the RNA sequencing results were not validated for gene (quantitative reverse transcription PCR) or protein expression.\nThe seven patients were categorised as critically severe (n=1), severe (n=4) and common type (n=2). Three additional patients classified as severe received placebo (vehicle) administration for comparison. Patients were followed for 14 days after MSC or placebo administration and a range of safety and efficacy end-points were assessed. No infusional toxicities, allergic reactions, secondary infections or severe attributable adverse events were observed, and patients, including the one categorised as critically severe, apparently demonstrated clinical improvements within 2–4 days after MSC administration. However, while detailed information is provided for the critically severe patient, there is a lack of corresponding information for the other six patients or for the three placebo patients. Analyses of viral titres, circulating pro- and anti-inflammatory mediators, and lymphocyte numbers and populations were presented in detail for the critically severe patient and to a lesser degree for the other patients.\nMore detailed information as to inclusion and exclusion criteria, timing of MSC administration relative to onset of disease, comorbidities, clinical course of each patient, and evaluation of inflammatory mediators and cell populations for both treated and placebo patients are needed to better determine potential MSC efficacy and mechanisms of action. Importantly, there is no discussion as to whether the approach be further investigated in only critically severe and/or severe patients or for the broader range of clinical presentations of COVID-19 respiratory infection.\nA second recently published study evaluated MSC administration in patients with H7N9 influenza virus respiratory infections during the 2013–2014 outbreak in China [48]. In this study, 17 critically ill patients with H7N9-induced ARDS received multiple intravenous administrations of menstrual blood-derived cells (106 cells per infusion in Plasmalyte) obtained from a single healthy donor and outcomes were compared to 44 comparably critically ill patients receiving standard antiviral and supportive therapies. Of the treated patients, three are described as receiving three separate infusions during early-stage infection, six patients received three infusions at late-stage infection and eight patients received four infusions at late-stage infection. However, no information is provided concerning the timing between infusions or whether the control patients received vehicle infusions. The MSC-treated and control patients were otherwise fairly well matched for comorbidities and degrees of multi-organ failure and for use of other supportive therapies, except for a higher incidence of shock in the MSC-treated group (p\u003c0.03). No apparent infusional toxicities or serious adverse events were noted. Three patients in the MSC-treated group died (82.4% survival), whereas 24 in the control died (45.5% survival). However, no details were provided on the deaths, including cause and timing related to either infusion or to overall clinical course, or on other standard assessments including ventilator-free days, ICU stay or hospital stay. Complete blood count and measures of renal, liver, cardiac, and coagulation functions were comparable, except for a higher circulating pro-calcitonin level in the control group, perhaps suggestive of secondary or co-bacterial infections, although no information on other infections was provided. The authors concluded that MSC administration is a viable approach for H7N9-induced ARDS and that this could be potentially applicable to use in COVID-19 patients.\nThese two studies, while suggestive, highlight a number of issues with respect to potential use of MSCs in coronavirus and other viral respiratory infections. These include but are not limited to source of MSCs, dose and dosing strategies, including the number and timing of administrations. These studies also highlight issues with conduct of clinical trials for respiratory diseases, including those in critically ill patients. Full information about inclusion and exclusion criteria, clinical course, comorbidities, co-infections and laboratory evaluations, including investigative mechanistic evaluations, must be provided in a comprehensive 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