Performance Cell Manufacturing (PCM), a contract development and manufacturing organization, recently manufactured and is providing stem cell doses for use in an FDA approved COVID-19 clinical trial. The clinical trial, which is being conducted by Sorrento Therapeutics (Nasdaq: SRNE, “Sorrento”), is evaluating the use of adipose derived stem cells for the treatment of acute respiratory distress syndrome (ARDS) caused by COVID-19.
Human adipose derived stem cell company, Personalized Stem Cells, Inc. (PSC), secured FDA approval for the clinical trial in July 2020. PCM was contracted to develop cell lines and manufacture the stem cells to be used for treatment. PSC, which primarily focuses on autologous stem cell therapy for orthopedics, then went on to out-license the allogeneic stem cell technology, including the FDA approved clinical trial, to Sorrento in October 2020.
Recently, Sorrento Therapeutics announced that four clinical trial participants completed treatment and that the preliminary safety and efficacy results look promising. There were no infusion-related adverse events reported in any of the patients. Additionally, the four patients that completed treatment were all discharged from the hospital within eight days of the initial stem cell infusion.
With promising preliminary safety results, PCM has scaled up production as contracted by Sorrento. PCM COO, Dr. Carolyn Wrightson, stated, “We continue to scale up manufacturing of stem cells to meet the anticipated needs of potential future clinical trials. Our recently expanded facility has allowed us to increase production to meet current and future demand.”
PCM was formed from over 15 years of experience with cGMP compliant cell therapy product development and manufacturing. PCM provides cell therapy development and cGMP contract manufacturing for companies for FDA phase 1 and phase 2 clinical trials.