HOUSTON, July 6, 2020 — Physician-investigators at Johns Hopkins University Hospital report on the promising data of treatment of COVID-19 induced acute respiratory distress syndrome with allogeneic, cord blood derived T-regulatory (Treg) cell therapy (manufactured by Cellenkos®), published in peer reviewed journal of Annals of Internal Medicine. Both patients were critically ill and intubated (one on ECMO). Both had failed Tociluzimab (Actemra, Roche) and had multiorgan failure. Patients received cell therapy under FDA Emergency Use IND for up to 3 doses. [Read more…]
How COVID-19 Is Impacting the Regenerative Medicine Sector
Today, we are facing a crisis that is unlike anything most of us have seen in our lifetimes. COVID-19 has brought health systems across the world to the fringe and forcefully closed schools, restaurants, events, and many other places around the world where we gather. The pandemic has killed countless lives and caused havoc in the lives of millions of workers. The ramifications of the pandemic are social and economic and will likely be felt for some time to come. [Read more…]
Citius to Pursue IND for Use of Its Induced MSCs in COVID-19 Induced ARDS
Citius receives FDA Response on Pre-IND application for its induced mesenchymal stem cells (iMSCs) to treat ARDS induced by COVID-19
FDA provides specific guidelines to study iPSC-derived MSCs, preparing Citius to submit an IND application for its iMSC therapy
The Citius iMSC is an allogeneic MSC product manufactured by expanding material from a master cell bank
Celltex Therapeutics Receives Another FDA Approval: Phase II Clinical Trial Using MSCs a Prophylactic Against COVID-19
June 26, 2020, HOUSTON — Celltex, a Houston, Texas-based biotechnology company, announced that it has received approval from the U.S. Food and Drug Administration (FDA) to proceed with the Company’s Investigational New Drug application (IND 22055) to investigate the Prophylactic Efficacy of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) Against Coronavirus Disease 2019 (COVID-19). [Read more…]
Funding for COVID-19 Countermeasures: Diagnostics, Vaccines, Treatments
COVID-19 is a global emergency of unprecedented scale. Affecting all 7.2 billion people worldwide, it is largest pandemic in modern history. Because it could take a year or two before vaccines get approved, manufactured at high volume, and distributed on a global scale, there’s a dire need for treatments to reduce the mortality rate of the coronavirus while we wait. To this end, agencies around the world have been rapidly announcing funding support for the development of diagnostics, vaccines and therapeutics against COVID-19. [Read more…]
