AUSTIN, Texas — ​​Direct Biologics, LLC, is announcing that it has received approval from FDA that it may proceed with a Phase II trial under an Investigational New Drug (IND) application for the use of ExoFlo™, a bone marrow-derived extracellular vesicle and exosome product, in the treatment of COVID-19 associated Acute Respiratory Distress Syndrome (ARDS). The ExoFlo Infusion Treatment for COVID-19 (EXIT COVID-19) Associated ARDS trial will be a multi-center, double-blind, randomized, placebo-controlled clinical trial. [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
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Citius receives FDA Response on Pre-IND application for its induced mesenchymal stem cells (iMSCs) to treat ARDS induced by COVID-19
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FDA provides specific guidelines to study iPSC-derived MSCs, preparing Citius to submit an IND application for its iMSC therapy
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The Citius iMSC is an allogeneic MSC product manufactured by expanding material from a master cell bank
Aspire Health Science Receives IND Approval to Test ACT-20 Cellular Therapy Against COVID-19 Pneumonia
Aspire Health Science Announces U.S. FDA approval of IND application regarding testing proprietary ACT-20 Cellular Therapy against COVID-19 Pneumonia and a partnering opportunity for Biotech Companies and Investors.
COVID-19 Pipelines – Cell Therapies, Diagnostics, Treatments, & Vaccines
While there is not yet an approved treatment for COVID-19, scientific, medical and regulatory agencies are making heroic efforts to bring out new medicines. Numerous COVID-19 product categories have emerged, including vaccines, antibodies, antivirals, repurposed drugs, RNA-based drugs, and cell-based therapies, as well as other approaches, such as enzymes, peptides and glycoproteins. [Read more…]