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The U.S. FDA has allowed Fate Therapeutics’ Investigational New Drug (IND) Application for FT500, positioning the company to launch the first clinical trial investigation of an iPSC-derived cell product within the United States.
FT500 is a universal, off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line. Fate Therapeutics broke this exciting news in an announcement released November 30, 2018. [Read more…]
Induced pluripotent stem cells are a type of pluripotent stem cell that can be created from differentiated (“adult”) cells. iPSCs are increasingly being explored for applications within drug development and discovery. This is because patient-derived somatic cells (for example, fibroblasts) can be reprogrammed to produce iPSCs that have disease-specific genetic aberrations. These cells can then be differentiated into the disease-affected cell type (for example, neurons in neurodegenerative diseases). [Read more…]
Longeveron LLC is a regenerative medicine company developing cellular solutions for aging-related diseases. The company is focused on the development of allogeneic (donor-derived) human mesenchymal stem cells (MSCs) that are harvested and grown at its manufacturing facility in Miami, Florida.
Longeveron’s MSC (LMSC) product is derived from the bone marrow of young, healthy adult donors.
In addition to manufacturing its own cells in this cGMP facility, Longeveron is conducting clinical trials and manufacturing cells for other parties through its cell therapy CMO business. A contract manufacturing organization (CMO) is a company that provides manufacturing services to cell and gene therapy companies on a contract basis. [Read more…]
Glasgow, United Kingdom; 22nd October 2018: Sistemic Ltd. is pleased to announce the completion of a Global Service and License Agreement for its SistemPSCCheck™ assay with Australian stem cell and regenerative medicine company, Cynata Therapeutics Ltd. The agreement will see the use of the SistemPSCCheck™ assay for the assessment of residual pluripotent stem cells in Cynata’s current iPSC-derived MSC clinical candidate CYP-001, as well other planned iPSC-derived MSC products.
SistemPSCCheck™ is a first-in-class miRNA-based assay for high sensitivity assessment of residual pluripotent stem cells (PSCs) in derived cell preparations. It has been specifically designed to offer high levels of safety for characterisation and batch release testing to support the clinical and commercial development of PSC cell-derived cell therapy products. [Read more…]
CHAMP Private Equity is acquiring Cell Care, the largest cord blood bank within Australia, according to news released October 10, 2018, by the Australian Financial Review (AFR). According to AFR, “It is understood CHAMP will take a controlling stake in the business, while some of the vending shareholders will retain a minority shareholding.”
The transaction has important implications for the global stem cell banking marketplace, because the AFR estimates the deal to have a price tag of more than $100 million.
With this price tag, Cell Care will be well capitalized to continue its research into therapeutic applications of cord blood and tissue stem cells and may be positioned to expand into new markets beyond Australia and Canada.
[Read more…]
