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Cynata Completes Phase I Trial for CYP-001, Triggers Option Window for Fujifilm

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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™

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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

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Cynata TherapeuticsCynata 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…]

Parkinson’s Disease Clinical Trial to Launch in Japan | iPS Cell Trial

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Japan will continue its dominance with iPS cell clinical trials with the launch of a physician-lead trial for Parkinson’s disease. In its July 2018 press announcement, Kyoto University announced that its University Hospital and the Center for iPS Cell Research and Application (CiRA) will launch the world’s first clinical trial for Parkinson’s disease to utilize an induced pluripotent stem cell (iPS cell) derived therapeutic product.

Existing iPS Cell Trials

This newest iPS cell trial represents only the third iPS cell trial to be undertaken worldwide. The other existing iPS cell trials are being conducted by the RIKEN Center for Developmental Biology (CDC) and Cynata Therapeutics (ASX:CYP), respectively. [Read more…]

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