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…]
GIOSTAR Reports on a Positive Outcome of a COVID-19 Patient After Stem Cell Treatment
Promising results point to a potential alternative in combating the pandemic
San Diego, July 28, 2020 — Global Institute of Stem Cell Therapy and Research (GIOSTAR), the worldwide leader in stem cell research, is pleased to announce the outcome of a COVID-19 patient treated using stem cells. Led by Chairman and Co-Founder Dr. Anand Srivastava, GIOSTAR received approval for the treatment under the U.S. Food and Drug Administration (FDA) “expanded access for compassionate use” program. As of July 14, 2020, there have been more than 13 million COVID-19 cases and over 500,000 deaths worldwide. [Read more…]
Critically Ill COVID-19 Patient Successfully Treated with Vitro Biopharma’s AlloRx Stem Cells(R)
GOLDEN, CO July 14, 2020 — Vitro Diagnostics, Inc. (OTC PINK:VODG), dba Vitro Biopharma, jointly with GIOSTAR – a San Diego, California-based institution headed by Dr. Anand Srivastava, a pioneer in stem cell science – announced the results of treatment of a critically ill COVID-19 patient with its lead clinical product AlloRx Stem Cells®. [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
