In February, we announced preliminary results in a COVID-19 stem cell clinical trial that we licensed to Sorrento Therapeutics. To give a bit of backstory for those who may be new to our blog, Personalized Stem Cells went to work in the early pandemic days to manufacture doses and secure FDA approval for a COVID-19 clinical trial. We received FDA approval to conduct the clinical trial in July of 2020. Since our primary focus is on stem cell therapy for orthopedic issues, we determined the best course of action was to license out the clinical trial to a local biotech company, Sorrento Therapeutics.
COVID-19 Stem Cell Clinical Trial
The purpose of the clinical trial is to study the use of allogeneic (donor derived) stem cells to treat COVID-19 induced acute respiratory distress syndrome (ARDS). As a phase 1b study, the primary objective is to focus on the safety of the stem cell treatments. Patients participating in the COVID-19 clinical trial will receive one injection of stem cells every other day for a total of three injections. The stem cell treatments, termed COVI-MSC™ by Sorrento, are administered intravenously.
Initial Results from COVID-19 Clinical Trial
In January, Sorrento announced preliminary results from the COVID-19 clinical trial. At the time, four patients had been treated and all four patients were released from the ICU and discharged from the hospital shortly after completing treatment with the stem cells. In addition, there were no infusion related adverse events reported in any of the patients.
Recent Positive Results from COVID-19 Clinical Trial
We now have updated information from Sorrento and the results continue to look promising. In March, Sorrento announced five more patients have completed treatment. All nine patients (including the original four) 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. There continue to be no infusion related adverse events reported in any of the patients.
We are incredibly proud of our contribution to this project and look forward to future positive announcements from our licensee, Sorrento Therapeutics.