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Tuesday, April 20, 2021 10:31:55 AM
All 10 patients were discharged from hospital within three days after their last COVI-MSC infusion.No infusion-related adverse events were observed.Sorrento plans a pivotal, multi-country, multi-site, placebo-controlled study to support an EUA submission.
SAN DIEGO, April 20, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") announced today the completion of enrollment in its Phase 1b study of human allogeneic adipose-derived mesenchymal stem cells (COVI-MSC™) infusions to treat COVID-19 induced acute respiratory failure (ARD) or acute respiratory distress syndrome (ARDS). This current 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 up to three infusions for a total of 1 x 106 cells/kg, with patients being followed for 28 days following the final infusion.
A total of 10 patients (8 males/2 females; age range 24-65 years; 8 Caucasian/2 Asian; 7 Hispanic/Latino/3 non-Hispanic/Latino; height 64 to 70 inches; weight 66 to 130 kg) were enrolled and all were discharged from the hospital to home within three days of their last infusion. At baseline, all patients required oxygen supplementation and had PaO2/FiO2 ratios ranging from 135 to 256 (normal ? 400). All patients had various medical co-morbidities in addition to obesity. The 10th patient had been under treatment for nearly 2 weeks without improvement and was discharged after the 2nd COVI-MSC infusion with oxygen saturations in the high 90s on room air. On follow up days later, the patient was still doing well.
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