Coronavirus disease 2019 (COVID-19), a pneumonia-like disease caused by the virus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), reached pandemic proportions in early 2020.
Severe COVID-19 is believed to result from hyperinflammation, overactive immune response triggering cytokine storms, and a prothrombotic state collectively determined as immunothrombosis, all elicited by SARS-CoV-2 infection. Acute respiratory distress syndrome (ARDS) in COVID-19 is associated with high mortality.
Mortality in patients with COVID-19 and ARDS was reported to be 52.4%.There is an urgent need for novel therapies that can attenuate the excessive inflammatory response associated with the immunopathological cytokine storm and immunothrombosis.
New data shows Therapeutic Solutions International Inc. ‘s JadiCell™ universal donor stem cell therapy substantially improved survival in end-stage patients with COVID-19 associated ARDS.
Mesenchymal stem cells (MSCs), such as those in the JadiCell therapy, are known to exert immunomodulatory and anti-inflammatory effects; therefore, it was thought that they could be beneficial to patients with COVID-19 associated ARDS.
Researchers evaluated the safety and efficacy of infusions of MSCs derived from umbilical cord tissue (UC-MSCs) – the JadiCell therapy – in subjects with COVID-19 ARDS. 24 subjects were in the study and received either UC-MSC or the control. Subjects in the UC-MSC treatment group received two intravenous infusions given 72 hours apart (at day zero and three) of 100 million UC-MSCs per infusion. Both groups received the best standard of care. The results were published in the journal Stem Cells Translational Medicine.
No adverse events were seen in the UC-MSC treatment group. A total of nine deaths were documented by day 28 after the second infusion, two in the UC-MSC treatment group (one unrelated to treatment) and seven in the control group. As a result of this, UC-MSC infusions in COVID-19 ARDS were found to be safe.
In the trial, treatment with UC-MSC infusions resulted in significantly decreased levels of inflammatory cytokines associated with ARDS at day six, as well as significantly improved patient survival – 91% for UC-MSC infusions versus 42% for control – and time to recovery.
The company is planning to initiate a phase III pivotal registration trial and seek marketing approval for use of JadiCell in ARDS and other lung diseases.
Giacomo Lanzoni, et al. Umbilical cord mesenchymal stem cells for COVID-19 acute respiratory distress syndrome: A double-blind, phase 1/2a, randomized controlled trial. Stem Cells Translational Medicine. Jan 2021. Volume 10, Issue 5 p. 660-673.