The FDA Approving Experimental Stem Cell Therapies Targeting Patients with Severe COVID-19 Cases

The FDA Approving Experimental Stem Cell Therapies Targeting Patients with Severe COVID-19 Cases TrialsiteN

Novel medical innovations are being pursued by biotech companies and clinical investigators to halt COVID-19 causalities as there is, presently, no approved treatment for the novel coronavirus—especially in severe, escalated conditions where mortality is more likely. A number of leading therapy candidates are involved with clinical trials from Gilead’s remdesivir to the anti-malarial drug hydroxychloroquine to powerful anti-inflammation drugs. Additionally, over 60 vaccines are now in the pipeline with two in clinical trials but any approved product is likely at least a year away. Moreover, now that the FDA has offered Emergency Authorization, a growing number of physicians use convalescent plasma (donated blood from those who have recovered from SARS-CoV-2) to transfuse into sick patients. On the more advanced edge, the FDA has given the nod to a number of stem cell therapy companies as well, an interesting approach due to their immunomodulatory dynamics as well their regenerative properties which could be applied to damaged lungs. But many suggest proceeding with caution.

TrialSite News has reported that as the pandemic unfolds, with over 1.8 million cases and nearly 115,000 deaths worldwide, the pathogen has a three-fold mortality rate over a standard influenza. And that a subgroup of patients with severe COVID-19 face a condition known as acute respiratory distress syndrome (ARDS). Once this condition is triggered, a dangerous reaction associated with the patient’s mortality, is the cytokine storm syndrome—an extremely dangerous acute inflammatory response occurring when large numbers of white blood cells are activated and release inflammatory cytokines, which in turn activate yet more white blood cells as the body reacts violently to the invading pathogen. The net result is a horrific situation where key organs like the lung are worn out and stop functioning.  Consequently, investigators are pursing different experimental treatments to stop this deadly process, including with regenerative medicine.

In China, TrialSite News has reported on a number of experimental regenerative therapy trials targeting patients with COVID-19. Reports coming out of that country evidence some success but many on this side of the Pacific suggest that Americans proceed with caution

What follows is a brief overview of regenerative medicine activities targeting COVID-19. 

Stem Cell Therapy Activities in the U.S.

In the United States, TrialSite News introduced a New Jersey-based stem cell therapy firm, Celularity, and their submitted investigatory new drug (IND) application to the FDA. Shortly thereafter, the FDA gave the greenlight to the trial for their proprietary therapy called CYNK-001 derived from allogeneic cellular therapies from human placentas.

TrialSite News recently covered the recent FDA clearance of Australia-based Mesoblast, to treat patients with ARDS caused by COVID-19 with intravenous infusions of its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L. The hypothesis behind Remestemcel-L: the regenerative therapy will inhibit production of inflammatory cytokines by white blood cells and promote anti-inflammatory cells.

In Texas, Hope Biosciences received FDA approval for a Phase II clinical trial evaluating the efficacy and safety of their autologous, adipose-derived mesenchymal stem cells (HB-adMSCs) to offer immune support against COVID-19. Apparently in a recent Rheumatoid Arthritis study, HB-adMSCs were deemed safe and effective. Yes, another Texas-based biotech venture known as Celtex Therapeutics recently submitted an emergency expanded access clinical study request to the FDA that would allow patients with COVID-19 to receive infusions of autologous Adipose-tissue derived Mesenchymal Stem Cells (AdMSCs) in the United States. Part of this proposed study includes Dr. Ashok K. Shetty, Professor, Texas A&M University Institute for Regenerative Medicine, and Dr. Derek W. Guillory, principal Investigator, Root Causes Medicine San Antonio.