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…]
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
Why is Healthy Donor Tissue So Important for Cell and Gene Therapies?
Brad Taylor, PhD and Dominic Clarke, PhD
HemaCare Corporation 8500 Balboa Boulevard Suite 130 Northridge CA 91325
Public discourse on cell and gene therapy is focused on novel approaches to long-established procedures such as bone marrow transplants, as well as on truly innovative treatments such as cancer immunotherapy and stem cell therapy for autoimmune disorders and other serious ailments. Positive clinical trial results and the demonstrated success of advanced therapies such as Kymriah® and Yescarta® are fueling a sense of excitement on what could be accomplished with these medicines—and driving a significant increase in the number of cell therapies in the clinical trial pipeline. As of last year, there were nearly 300 different cell and gene therapies in development, and that number is on target to grow.[1] [Read more…]
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