In a short time, the novel coronavirus disease (COVID-19) has destructively impacted both the people of the world and the global economy on a historic scale. As of April 27th 2020, the World Health Organization (WHO) reports over 3,002,303 confirmed cases globally, with the worldwide death toll rising above 208,131.
There is presently no approved treatment or vaccine for COVID-19, although several pharmaceutical companies in the United States and abroad continue to pursue testing and funding for development. Still, many sources indicate that the time required to get a potential COVID-19 vaccine to market is likely a minimum of 12 months.
Through partnership with Personalized Stem Cells, Inc. (PSC), Calidi Biotherapeutics has funded the research and advancement of patent-pending stem cell lines—which substantial new evidence suggests may be beneficial in the treatment of COVID-19 and associated Acute Respiratory Distress Syndrome (ARDS).
Years of research demonstrate that mesenchymal stem cells (MSCs) possess antimicrobial qualities, as well as the ability to reduce inflammation, fibrosis formation, and immune system overreactivity—which has been identified as a potential major cause in COVID-19 related deaths.
Since March 2019, Calidi has created fat-derived MSC stem cell banks from healthy adult donors in accordance with strict FDA guidelines, to offer an “off-the-shelf” supply for cancer therapy that can additionally be used for emergency care and lung disease treatment. With Calidi’s investment, PSC is leading a COVID-19 solution which leverages our MSC inventory, giving our partner a headstart in the stem cell drug manufacturing process.
In the PSC-Calidi approach, we are proposing to use these MSCs for direct infusion in patients with advanced COVID-19, enabling the expedited deployment of their therapeutic effects. Stem cell therapy is one of the few avenues that directly treats lung inflammation in such patients. We believe that our treatment also has the capability to stunt the spread of viral and bacterial infections in the lungs while preventing long-term impairments in patients recovering from pneumonia and ARDS.
MSC-based therapeutic strategies are being clinically validated by studies in Israel and China to treat pneumonia/ARDS in patients infected with COVID-19. Early reports from these clinical trials underscore MSCs’ significant healing capacity, with patient success data noting relief of symptoms and pneumonia after several stem cell doses. Israel announced a 100% recovery of seven COVID-19 patients after compassionate treatment with MSCs, and collaborators in Wuhan and Beijing share similar results.
By request of the White House Task Force, Calidi’s manufacturing partner, PSC, is applying for expedited FDA review of their Investigational New Drug (IND) application. PSC’s COVID-19 clinical trials are planned to commence in May under the guidance of three prominent Critical Care & Pulmonary Medicine clinical collaborators: Barzan Mohedin, MD and Kaveh Bagheri, MD at Sharp Grossmont Hospital, as well as Naveen Gupta, MD at UCSD.
Calidi believes that our innovative therapy carries the potential to swiftly and effectively mitigate both the severity and mortality rate of respiratory failure related to COVID-19 and future viral respiratory diseases.
Personalized Stem Cells is a US-based biopharmaceutical company with patents covering stem cell therapies, including an IND application being filed with the FDA for stem cell treatment of lung disease. Our alliance has allowed for the development of stem cell lines and the creation of a mesenchymal stem cell bank.