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
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…]
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…]
Fate Therapeutics Announces FDA Clearance of IND Application for FT538, First CRISPR-edited, iPSC-derived Cell Therapy
Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company focused on the development of programmed cellular immunotherapies for cancer and immune disorders, announced the U.S. FDA has cleared its Investigational New Drug (IND) application for FT538.
FT538 is the first CRISPR-edited, iPSC-derived cell therapy under development worldwide. [Read more…]
Author: Jean-Philippe Richard, Ph. D. ([email protected])
Parkinson’s Disease (PD) affects some 10 million people worldwide, most commonly in patients over the age of 50. PD is associated with the loss of dopaminergic neurons in the substantia nigra region of the brain, leading to the characteristic tremors in the extremities, among other symptoms. There is a need for models of PD to help discover new therapies. To help address this need, we generated and characterized iPSC-derived PD dopaminergic neurons as a test case for functional neural differentiation. [Read more…]