Acute respiratory distress syndrome (ARDS) in COVID‐19 is associated with high mortality. Mesenchymal stem cells are known to exert immunomodulatory and anti‐inflammatory effects and could yield beneficial effects in COVID‐19 ARDS. The objective of this study was to determine safety and explore efficacy of umbilical cord mesenchymal stem cell (UC‐MSC) infusions in subjects with COVID‐19 ARDS. A double‐blind, phase 1/2a, randomized, controlled trial was performed. Randomization and stratification by ARDS severity was used to foster balance among groups. All subjects were analyzed under intention to treat design. Twenty‐four subjects were randomized 1:1 to either UC‐MSC treatment (n = 12) or the control group (n = 12). Subjects in the UC‐MSC treatment group received two intravenous infusions (at day 0 and 3) of 100 ± 20 × 106 UC‐MSCs; controls received two infusions of vehicle solution. Both groups received best standard of care. Primary endpoint was safety (adverse events [AEs]) within 6 hours; cardiac arrest or death within 24 hours postinfusion). Secondary endpoints included patient survival at 31 days after the first infusion and time to recovery. No difference was observed between groups in infusion‐associated AEs. No serious adverse events (SAEs) were observed related to UC‐MSC infusions. UC‐MSC infusions in COVID‐19 ARDS were found to be safe. Inflammatory cytokines were significantly decreased in UC‐MSC‐treated subjects at day 6. Treatment was associated with significantly improved patient survival (91% vs 42%, P = .015), SAE‐free survival (P = .008), and time to recovery (P = .03). UC‐MSC infusions are safe and could be beneficial in treating subjects with COVID‐19 ARDS.

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SummarySpinal epidural abscess (SEA) is a rare but potentially devastating condition. We noticed an increase in the number of cases of SEA, with the majority in hemodialysis (HD) patients. This prompted a retrospective chart review of all cases of SEA admitted from 2000 to 2005 and a literature search of similar cases. We identified 19 SEA cases treated at Long Island College Hospital during this 6-year period, of which six were on HD: four were dialyzed via catheter, one via arteriovenous fistula, and in one the method of dialysis was not documented. Four patients had bacteremia with Staphylococcus aureus. Four patients presented with paresis or paralysis; only one improved. The mortality rate was 33% (2/6). We found 30 other cases of SEA in patients on HD from the literature. These 36 HD cases were compared with 85 SEA cases that were not on HD (13 from our study and 72 described in two large case series). The mortality rate was noted to be much higher in HD patients (23% [6/26] versus 7% [6/85]). Neurologic deficit at presentation was noted in 47% (17/36) of HD patients versus 69% (59/85) of non-HD patients, but neurologic improvement was higher in non-HD patients (71% [42/59] versus 29% [5/17]). This is the largest literature review of SEA in patients on HD. When compared with non-HD patients, HD patients had a higher mortality rate and were less likely to improve neurologically.

Our data suggest that polymyxin B may be effective for MDR gram-negative infections in patients with limited therapeutic options, but precautions should be taken to avoid toxicity.

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