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
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…]
Orca Bio Raises $192M Series D to Develop High Precision Allogenic Cell Therapies
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
The Dawn of iPSC-Derived Cell Therapeutics
Despite progress involving the use of induced pluripotent stem cells (iPSCs) within disease modeling and drug discovery applications, it will be a long path to achieve the broad-scale use of iPSC-derived cell types in human patients.
Within a preclinical context, cell types differentiated from iPSCs are tested for their therapeutic response by using animal models. Then, clinical trials are conducted to assure that essential parameters, such as tumorigenicity, dose toxicity, and immunogenicity, are assessed before authorizing the product for use in human patients. [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…]
