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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…]
5 Questions to Ask Your Doctor About Stem Cell Transplants
Stem cell transplants are used to treat certain types of cancer as well as some other conditions. Stem cell transplants have even completely eradicated HIV in some patients.
If you are considering stem cell transplants for your health issues, you will understandably have a lot of questions.
Knowing the right questions to ask about this complex procedure isn’t always that easy, however. We’re here to help with that.
Read on as we look at five important questions to ask your doctor about stem cell transplants. [Read more…]
Cynata to Launch World’s First Phase 3 Trial with an iPSC-Derived Cell Therapeutic
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. The clinical trial is set to achieve two world-firsts:
- It will be the world’s first clinical trial involving an iPSC-derived cell therapeutic product to enter Phase 3.
- It will be the largest trial ever completed with an iPSC-derived cell therapeutic, with an anticipated enrollment of 440 patients.
Gamida Cell, President Dr. Yael Margolin Reveals the Unmet Need in HSCT
Gamida Cell is a cell therapy company that is best known for its innovative approaches to hematopoietic stem cell transplantation (HSCT). Headquartered in Jerusalem, Israel, Gamida Cell has been advancing several clinical programs using ex vivo expanded hematopoietic stem cells (HSCs) created using its proprietary nicotinamide (NAM) technology.
I had the honor of interviewing Dr. Yael Margolin, President of Gamida Cell. In this interview, we discuss how Gamida Cell is using cell therapeutics to address the unmet need in hematopoietic stem cell transplantation (HSCT). [Read more…]
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