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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
Mesenchymal Stem Cells (MSCs)
Mesenchymal stem cells (MSCs) are a well-characterized population of adult stem cells that can differentiate into a variety of cell types (chondrocytes, osteoblasts, adipocytes, myocytes, and more).
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…]
MSCs, The Most Suitable Cells for COVID-19?
Since the outbreak of the new type of coronavirus pneumonia (COVID-19) in December 2019, the scientific community has been working fervently to develop treatments to combat the disease. Globally, scientists are exploring every potential weapon to suppress the global threat. Approaches under investigation include vaccines, medications, combination therapies, and perhaps most interestingly, living therapies with promising cell types such as natural killer (NK) cells, stem cells and exosomes. [Read more…]
Citius to License Novellus’ iPSC-derived MSCs for COVID-19 Related Complications
– Novellus’ patented mRNA-based cell-reprogramming technology creates MSCs with superior immunomodulatory properties
– Novellus’ iPSC-derived MSCs have manufacturing advantages over primary adult, donor-derived MSCs, allowing for larger supply, faster scale-up, and a more consistent cellular product
– MSCs may remedy the cytokine storm that triggers acute respiratory distress syndrome (ARDS) in COVID-19 patients
First Patient Dosed in Phase I Clinical Trial using RoosterBio’s Cellular Starting Materials
Investigational New Drug (IND) Using RoosterBio’s CliniControl™ Products Enters the Clinic by RoosterBio’s Pharmaceutical Customer
RoosterBio Inc., a leading supplier of human mesenchymal stem/stromal cell (hMSC) working cell banks and hMSC bioprocess systems, announces today a significant milestone in the regenerative medicine field with the dosing of the first patient using its innovative cellular starting materials. The patient has been treated by RoosterBio’s pharmaceutical customer with an Investigational New Drug (IND) that was manufactured using RoosterBio’s CliniControl cell and media systems. [Read more…]
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