More patients have been treated in Sorrento Therapeutics’ COVID-19 FDA-approved clinical trial using stem cells manufactured by Performance Cell Manufacturing.
In late 2020, Performance Cell Manufacturing was contracted to manufacture stem cells for an FDA-approved stem cell clinical trial to treat COVID-19 induced acute respiratory distress syndrome (ARDS). The clinical trial was developed by Personalized Stem Cells, Inc. (PSC) and licensed to Sorrento Therapeutics (Nasdaq: SRNE, “Sorrento”).
In January, Sorrento announced the first positive results from the clinical trial. The initial announcement disclosed that four ICU patients had completed treatment and were discharged from the hospital. Recently, Sorrento announced updated results for a total of nine patients treated with allogeneic adipose-derived stem cells. All nine patients were in the hospital ICU with poor oxygenation and all nine patients were discharged from the hospital within days after completing the stem cell treatments. In addition, there have been no infusion-related adverse events reported in any of the patients.
The objective of this non-randomized, Phase 1b study is to evaluate the safety and preliminary efficacy of adipose-derived stem cell therapy for the treatment of ARDS resulting from infection with COVID-19. Patients enrolled in the clinical trial will receive one intravenous infusion of stem cells every other day for a total of three infusions.
The stem cell platform and FDA approval for the clinical trial were secured by Personalized Stem Cells shortly after COVID-19 was declared a global pandemic. Personalized Stem Cells granted global rights to its adipose-derived allogeneic mesenchymal stem cell (MSC) program, including the COVID-19 therapy candidate, to Sorrento in October 2020.
PCM founder and CEO, Dr. Bob Harman, stated, “We continue to be proud of our contribution to this FDA approved COVID-19 clinical trial. The preliminary safety profile speaks, in part, to our team’s dedication to quality manufacturing. We look forward to additional positive announcements from Sorrento.”