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Sorrento announces updated positive results of phase 1b study of COVI-MSC for treatment of ICU COVID-19 ARD patients.

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Last updated:24th Sep 2021
Published:27th Mar 2021
Sorrento Therapeutics, Inc.announced updated positive results from its Phase 1b study of human allogeneic adipose-derived mesenchymal stem cells (COVI-MSC) for patients suffering from COVID-19-induced acute respiratory distress (ARD) or acute respiratory distress syndrome (ARDS). This ongoing study (MSC-COV-101) is a single arm, non-randomized Phase 1b study of the safety and preliminary efficacy of COVI-MSCs administered every other day for three infusions for a total of 1 x 106 cells/kg. The primary objective of this study is to evaluate the safety of intravenous infusion of allogeneic adipose MSC cells in patients with COVID-19-induced ARD or ARDS. Intensive care unit (ICU) patients with COVID-19-induced respiratory failure, diffuse pulmonary infiltrates and evidence of poor oxygenation: ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) ranging from an average of 135 to 225 (normal range ? 400) were enrolled. All nine patients responded rapidly with markedly reduced need for high inspired oxygen concentration and were able to be transferred out of the ICU and discharged from the hospital within several days of their 3rd COVI-MSC infusion. No infusion related safety events have been reported. Dr. Eyad Almasri, Associate Professor of Medicine, Pulmonary, Critical Care and Sleep Medicine at UCSF Fresno, is the principal investigator in this ongoing study. Currently, Sorrento is working with the FDA to plan a placebo-controlled Phase II study to be conducted across multiple sites in the United States, Brazil and Mexico, and to determine the sample size and data necessary to support an emergency use authorization (EUA).
Condition: Coronavirus/ARDS
Type: drug

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