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The Dawn of iPSC-Derived Cell Therapeutics

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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…]

Cynata to Launch World’s First Phase 3 Trial with an iPSC-Derived Cell Therapeutic

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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’ CRISPR-edited, iPSC-derived Cell Therapy Cleared for Clinical Investigation

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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…]

Induced Pluripotent Stem Cell (iPS Cell) Applications in 2020

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Since the discovery of induced pluripotent stem cells (iPSCs) in 2006, a large and thriving research products market has emerged, largely because the cells are non-controversial and can be generated directly from adult cells. It is clear that iPSCs represent a lucrative market segment, because methods for commercializing this cell type are expanding every year and clinical studies investigating iPSCs are swelling in number. [Read more…]

I Peace, Inc. Introduces Clinical-Grade iPS Cell Custom Manufacturing Service

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PALO ALTO, Calif., May 15, 2020 — I Peace, Inc. (CEO: Koji Tanabe), a Palo Alto-based biotech start-up focusing on Nobel Prize-wining technology “induced pluripotent stem cell (iPSC)” began manufacturing clinical-grade iPSCs. We are now officially taking orders for custom manufacturing of clinical-grade iPSCs from institutions around the world.

On March 11, 2020, the company received a license to manufacture clinical-grade cells from Japan’s Ministry of Health, Labour and Welfare for its cell manufacturing facility located in Kyoto, Japan. [Read more…]

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