Intravenous Mesenchymal Stem Cells in Extracorporeal Oxygenation Patients with Severe COVID-19 Acute Respiratory Distress Syndrome

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1. 

   ScreenIT

   Mar 1, 2021

   SciScore for 10.1101/2020.10.15.20122523: (What is this?)

   Please note, not all rigor criteria are appropriate for all manuscripts.

   Table 1: Rigor

   Institutional Review Board Statement	IRB: We used single patient emergency-access FDA approval, local Institute Review Board (IRB) approval, and a legal authorized representative for intubated patients provided informed consent. Consent: We used single patient emergency-access FDA approval, local Institute Review Board (IRB) approval, and a legal authorized representative for intubated patients provided informed consent.
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.
   Sex as a biological variable	not detected.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   The PVDF membrane was blocked with 5% non-fat milk prepared in 1x phosphate buffered saline (PBS) and was probed with …

   SciScore for 10.1101/2020.10.15.20122523: (What is this?)

   Please note, not all rigor criteria are appropriate for all manuscripts.

   Table 1: Rigor

   Institutional Review Board Statement	IRB: We used single patient emergency-access FDA approval, local Institute Review Board (IRB) approval, and a legal authorized representative for intubated patients provided informed consent. Consent: We used single patient emergency-access FDA approval, local Institute Review Board (IRB) approval, and a legal authorized representative for intubated patients provided informed consent.
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.
   Sex as a biological variable	not detected.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   The PVDF membrane was blocked with 5% non-fat milk prepared in 1x phosphate buffered saline (PBS) and was probed with exosome-specific marker CD9 (312102, BioLegend) and SARS-CoV-2 spike (GTX632604, GeneTex) were used as primary antibodies and goat-anti-mouse conjugated with horse radish peroxidase (7076, Cell Signaling Technology) were used as secondary antibody.	CD9 suggested: (BioLegend Cat# 312102, RRID:AB_314907) GTX632604 suggested: (GeneTex Cat# GTX632604, RRID:AB_2864418) goat-anti-mouse suggested: (Electron Microscopy Sciences Cat# 815.022, RRID:AB_2629849)
   The wells were again washed, incubated with 100uL of Anti-Human IgG (Fab specific) HRP-labeled secondary antibody (1:12000) in the dark at 20 ° C for 1h, washed with PBS-T, incubated with 100uL of TMB substrate for 10 minutes followed by 100uL of 1N Sulfuric Acid (SigmaAldrich, Saint Louis MO) to stop the reaction.	Anti-Human IgG suggested: (LSBio (LifeSpan Cat# LS-C12000-200, RRID:AB_861033)
   Software and Algorithms
   Sentences	Resources
   The intensity of SARS-CoV-2 spike antigen was quantified using ImageJ software and normalized with CD9. Anti-SARS-CoV-2 IgG ELISA methodology: Anti-SARS-CoV-2 IgG levels were measured in the plasma of COVID 19 patients by following the methodology of Stadlbauer and colleagues (20)	ImageJ suggested: (ImageJ, RRID:SCR_003070)

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   Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

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   Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:

   Even so, the major limitation of the latter study is that the 7 COVID-19 patients were not categorized as having severe ARDS, rather they had at most mild ARDS. In our study, we administered MSCs to 12 patients admitted to hospital with severe ARDS, 9 of whom had a requirement for ECMO support. MSC intravenous administration had no serious adverse effects. Timing of MSC administration may be critical to achieve a more robust clinical response as most of the patients received MSCs late in their hospital course. This report offers an important clinical insight as all ongoing or planned clinical trials for cell-based infusions excludes ECMO COVID-19 patients who are the most critically ill and therefore challenges the therapeutic MSC intervention to its highest capacity. Considering the high mortality of COVID-19 ECMO administered patients, MSC infusion needs to be further evaluated in this highly selective gravely ill patient population as well as less severe ARDS patients. This study has important limitations that warrant mention. First, this was a small clinical experience of 12 patients that lacked a randomized control group. Nonetheless the ability to compare mortality with a contemporaneous control group and a world-wide global experience is supportive of the potential clinical merits of this approach. In addition, the change in PaO2/FiO2, SOFA and VEGF-A and IL12p70 levels after MSC infusion provided encouraging positive endpoints that warrant further investigation of MSC...

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   Results from TrialIdentifier: No clinical trial numbers were referenced.

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   Results from Barzooka: We found bar graphs of continuous data. We recommend replacing bar graphs with more informative graphics, as many different datasets can lead to the same bar graph. The actual data may suggest different conclusions from the summary statistics. For more information, please see Weissgerber et al (2015).

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   Results from JetFighter: We did not find any issues relating to colormaps.

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   Results from rtransparent:

   • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
   • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
   • No protocol registration statement was detected.

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   Read the original source
2. 

   Version published to 10.1101/2020.10.15.20122523v2 on medRxiv

   Nov 11, 2020
3. 

   Version published to 10.1101/2020.10.15.20122523v1 on medRxiv

   Oct 20, 2020