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
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…]
Company aims to safely and effectively regenerate a healthy blood and immune system for patients with hematological malignancies, genetic diseases and autoimmune disorders
High precision cell therapies manufactured by Orca Bio have the potential to replace conventional bone marrow transplants and expand the eligible patient population
With an anticipated enrollment of 440 patients, it will be the world’s largest trial ever completed with an iPSC-derived cell therapeutic.
It’s official. Australian stem cell company Cynata Therapeutics is preparing to test its iPSC-derived cell therapeutic, CYP 004, in a Phase 3 clinical trial enrolling up to 440 patients.
Led by the University of Sydney and funded by the Australian Government National Health and Medical Research Council (NHMRC), the historic trial will assess whether Cynata’s cell therapeutic, CYP-004, has the capacity to improve patient outcomes in osteoarthritis (OA).
CYP-004 is an allogeneic, iPSC-derived mesenchymal stem cell (MSC) product derived using Cynata’s proprietary Cymerus™ technology. [Read more…]