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Home » cynata therapeutics » Page 2

iPS Cell Therapy: Is Japan the Market Leader?

June 28, 2018 By Cade Hildreth (CEO)

Although there are key players in markets like the U.S., Australia, and the EU, Japan continues to accelerates its position as a hub for induced pluripotent stem cell (iPS cell) therapy with generous funding, acquisitions, and strategic partnerships.

[Read more…]

4.9 / 5 ( 30 votes )

Filed Under: iPS Cells, Stem Cells Tagged With: cynata therapeutics, FUJIFILM, iPS cells, iPSC, Japan

Cynata Reports Positive 28-day Data from Cohort B of Phase 1 Trial of CYP-001 in GvHD

June 27, 2018 By Cade Hildreth (CEO)

Cynata 28 Day Data CYP-001

MELBOURNE, Australia, June 21, 2018 — Australian stem cell and regenerative medicine company Cynata Therapeutics Limited (ASX:CYP) is pleased to announce positive safety and efficacy data from a day 28 analysis of patients in Cohort B of its Phase 1 clinical trial of CYP-001, the Company’s lead Cymerus™ mesenchymal stem cell (MSC) product candidate, in steroid-resistant acute graft-versus-host disease (GvHD). [Read more…]

5 / 5 ( 1 vote )

Filed Under: iPS Cells, MSCs Tagged With: clinical trial, cynata therapeutics

Exciting Early Results in Cynata’s UK Trial of iPSC-Derived MSC Therapeutic Product

January 28, 2018 By Cade Hildreth (CEO)

Cynata Early Trial Results CYP-001

 Patients in Cohort A Respond Well, 1st Patient in Cohort B Dosed in Cynata’s CYP-001 Trial

Cynata TherapeuticsAustralian stem cell company, Cynata Therapeutics has released exciting early results from its ongoing clinical trial in the UK utilizing an iPS cell-derived mesenchymal stem cell (MSC) therapeutic product. [Read more…]

Filed Under: iPS Cells, MSCs, News Tagged With: clinical trial, cynata therapeutics

Cynata’s Cymerus™ Platform Technology – What is It, Exactly?

December 8, 2017 By Cade Hildreth (CEO)

Cynata Cymerus Technology

What is Cynata’s Cymerus™ Technology?

Cynata TherapeuticsThe Cymerus™ technology is a stem cell manufacturing platform being developed by Cynata Therapeutics Limited (ASX: CYP), an Australian regenerative medicine company. The Cymerus™ technology utilizes induced pluripotent stem cells (iPSCs) originating from an adult donor as the starting material for generating mesenchymoangioblasts (MCAs), and subsequently, for differentiating the cells into mesenchymal stem cells (MSCs). [Read more…]

5 / 5 ( 1 vote )

Filed Under: iPS Cells, MSCs, Stem Cells Tagged With: cynata therapeutics, hMSC, iPSC, MSC

FDA Meeting Provides Clear Path for Cynata US Development Plans

July 5, 2017 By Cade Hildreth (CEO)

Cynata US Development
  • Cynata Pre-IND meeting with the US FDA completed successfully
  • FDA confirms CymerusTM manufacturing dossier meets expectations
  • Clear path determined for preclinical and clinical protocol requirements for product development in US
  • Potential to take advantage of fast-track provisions under the new 21st Century Cures Act

Cynata TherapeuticsMelbourne, Australia; 5 July 2017: Australian stem cell and regenerative medicine company, Cynata Therapeutics Limited (ASX: CYP), has received written advice from the United States Food and Drug Administration (FDA) regarding the regulatory approval path for Cynata’s proprietary CymerusTM mesenchymal stem cell (MSC) products in the US. This advice follows a pre-Investigational New Drug (pre-IND) meeting (announced 19 April 2017), which Cynata recently held with the FDA’s Office of Cellular, Tissue and Gene Therapies.

The FDA confirmed that the scope and substance of Cynata’s “Chemistry, Manufacturing and Controls” (CMC) dossier is commensurate with its expectations, which indicates that CymerusTM MSC products are expected to be of suitable quality for clinical trial use in the US. [Read more…]

Filed Under: iPS Cells, MSCs Tagged With: Cymerus, cynata therapeutics

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