Although there are key players in multiple geographies worldwide, Japan has positioned itself as a hub for induced pluripotent stem cell (iPS cell) technology. iPS cells are made by reprogramming adult cells back into an embryonic-like state. Derived from skin or blood cells, they are not controversial.
Cynata Receives Ethics Approval to Commence Clinical Trial in COVID-19 and Clinical Development Update
MELBOURNE, Australia, May 08, 2020 — Cynata Therapeutics Limited (ASX: “CYP”, “Cynata”, or the “Company”), a clinical-stage biotechnology company specialising in cell therapeutics, is pleased to announce that it has received ethics committee approval to commence a clinical trial to investigate early efficacy of Cynata’s proprietary Cymerus™ mesenchymal stem cells (MSCs) in adults admitted to intensive care with COVID-19. In addition, the Company also provides updated guidance on its wider clinical development pipeline. [Read more…]
Cynata Completes Phase I Trial for CYP-001, Triggers Option Window for Fujifilm
It is official. Australian stem cell company Cynata Therapeutics has completed the world’s first Phase I trial involving an induced pluripotent stem cell (iPSC) derived therapeutic product. The landmark study involved the company’s lead product, CYP-001, an iPSC-derived mesenchymal stem cell (MSC) product that can be manufactured at therapeutic grade and at mass scale using Cynata’s Cymerus™ platform technology.
Next, the company will be initiating Phase II trials in graft-versus-host disease (GvHD), critical limb ischemia (CLI) and osteoarthritis, showcasing the power of Cynata’s platform technology to be leveraged across multiple indications. Osteoarthritis will be Cynata’s largest clinical trial to date and also one of the largest ever for an MSC product. [Read more…]
Sistemic & Cynata sign Global Service & License Agreement for the use of SistemPSCCheck™
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…]
Cynata’s iPSC-derived Cell Therapeutic
(CYP-001) Meets Safety & Efficacy Endpoints
Cynata Therapeutics Ltd (ASX: CYP) is a clinical stage regenerative medicine company specializing in stem cell therapeutics that has a proprietary technology for manufacturing induced pluripotent stem cell (iPSC) derived mesenchymal stem cells (MSCs). Cynata is the only company in the world that can mass-produce therapeutic mesenchymal stem cells deriving from a single donor at a consistent quality and affordable cost. [Read more…]
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