ORLANDO, Fla., July 6, 2020 – Aspire Health Science, LLC (the “Company” or “Aspire”), is an FDA registered cGMP manufacturing facility specializing in the research, development, and manufacturing of cell-based therapies. [Read more…]
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Off-the-shelf NK cells in hematologic malignancies and oncology
Key Points:
- Natural killer (NK) cells represent innate immune cells with potent antitumor activity.
- Glycostem Therapeutics has established an innovative production process that yields high numbers of allogeneic NK cells with potent activity towards both hematologic and solid malignancies which can be used “off-the-shelf”.
- In a first-in-human phase I study in elderly patients with acute myeloid leukemia, these NK cells were well tolerated, had a favorable toxicity profile and were associated with promising efficacy.
- The possibility to genetically engineer the NK cells with chimeric antigen receptors or T cell receptors offers additional opportunities in immuno-oncology.
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
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…]
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