First patients treated in Sorrento Therapeutics’ COVID-19 FDA approved clinical trial using stem cells manufactured by Performance Cell Manufacturing.
POWAY, CA, UNITED STATES, February 9, 2021 /EINPresswire.com/ — Sorrento Therapeutics (Nasdaq: SRNE, “Sorrento”) announced positive results from the first patients treated in its COVID-19 clinical trial using stem cells licensed from and provided by Personalized Stem Cells, Inc. (PSC).
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. Performance Cell Manufacturing, the contract development and manufacturing division of VetStem Biopharma, was contracted to manufacture stem cells for the clinical trial. To jumpstart the process and speed stem cell manufacturing, a San Diego-based biotechnology company, Calidi Biotherapeutics, collaborated with PSC and PCM to provide critical cell lines. 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.
The objective of this Phase 1b study is to evaluate the safety and preliminary efficacy of adipose-derived stem cell therapy for the treatment of acute respiratory distress syndrome (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 treatments, termed COVI-MSC™ by Sorrento, have been administered to four patients thus far. According to the most recent announcement by Sorrento, all four patients have completed treatment and have been discharged from the hospital. The treatments were tolerated well and the patients improved rapidly. There were no infusion-related adverse events reported in any of the patients. Additional enrollment continues.
PCM founder and CEO, Dr. Bob Harman, stated, “We are honored to contribute to a project of such magnitude. The recent announcement by Sorrento regarding positive preliminary safety results is a major success in our field and critically important during this pandemic. We have continued to scale-up production of stem cells to meet the anticipated needs of the current clinical trial and future clinical trials.”
About Performance Cell Manufacturing
Performance Cell Manufacturing is the contract development and manufacturing division of VetStem Biopharma, Inc. PCM utilizes unique expertise acquired over the past 15 years of cell therapy development and manufacturing. The PCM team is focused on responding to the needs of cell therapy companies and applying technical, regulatory, and cGMP quality experience in order to form long term development and manufacturing relationships.
Michael Dale, Director of Business Development
Performance Cell Manufacturing
email us here