Abstract
Treatment of severe Coronavirus Disease 2019 (COVID-19) is challenging. We performed a phase 2 trial to assess the efficacy and safety of human umbilical cord-mesenchymal stem cells (UC-MSCs) to treat severe COVID-19 patients with lung damage, based on our phase 1 data. In this randomized, double-blind, and placebo-controlled trial, we recruited 101 severe COVID-19 patients with lung damage. They were randomly assigned at a 2:1 ratio to receive either UC-MSCs (4 × 107 cells per infusion) or placebo on day 0, 3, and 6. The primary endpoint was an altered proportion of whole lung lesion volumes from baseline to day 28. Other imaging outcomes, 6-minute walk test (6-MWT), maximum vital capacity, diffusing capacity, and adverse events were recorded and analyzed. In all, 100 COVID-19 patients were finally received either UC-MSCs (n = 65) or placebo (n = 35). UC-MSCs administration exerted numerical improvement in whole lung lesion volume from baseline to day 28 compared with the placebo (the median difference was −13.31%, 95% CI −29.14%, 2.13%, P = 0.080). UC-MSCs significantly reduced the proportions of solid component lesion volume compared with the placebo (median difference: −15.45%; 95% CI −30.82%, −0.39%; P = 0.043). The 6-MWT showed an increased distance in patients treated with UC-MSCs (difference: 27.00 m; 95% CI 0.00, 57.00; P = 0.057). The incidence of adverse events was similar in the two groups. These results suggest that UC-MSCs treatment is a safe and potentially effective therapeutic approach for COVID-19 patients with lung damage. A phase 3 trial is required to evaluate effects on reducing mortality and preventing long-term pulmonary disability. (Funded by The National Key R&D Program of China and others. ClinicalTrials.gov number, NCT04288102.
Highlights
The Coronavirus Disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection,[1] causes substantial damage to lungs, ranging from mild respiratory illness to severe acute respiratory syndrome, and death,[2,3,4]Dysregulated immune responses of both the innate and adaptive immune systems are associated with disease severity, lung damage, and long-term functional disability.[5,6,7,8] There are currently no prophylactic vaccines or effective antiviral agents available to treat COVID-19 and management of COVID-19 patients remains largely symptomatic and supportive therapy.[9]
6 reserve capability in the umbilical cord (UC)-Mesenchymal stem cells (MSC)-treated patients. These findings indicate that the use of UC-MSC as adjunctive therapy to standard of care treatment for patients with COVID-19 is a viable option
Our current trial showed that UC-MSCs therapy improved the resolution of the whole lung damage size, as detected by computed tomography (CT) scanning, the solid component lesions
Summary
The Coronavirus Disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection,[1] causes substantial damage to lungs, ranging from mild respiratory illness to severe acute respiratory syndrome, and death,[2,3,4]. Dysregulated immune responses of both the innate and adaptive immune systems are associated with disease severity, lung damage, and long-term functional disability.[5,6,7,8] There are currently no prophylactic vaccines or effective antiviral agents available to treat COVID-19 and management of COVID-19 patients remains largely symptomatic and supportive therapy.[9] there is an urgent need for safe and alternative therapeutic options to mitigate inflammatory organ injury. MSC treatment reduced the pathological changes of the lung and inhibits the cell-mediated immuneinflammatory response induced by the influenza virus in animal models and clinical trials.[14,15] The safety and potential efficacy of MSC have been evaluated in the patients with acute
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