Growing Blood Cells from Stem Cells Fate Therapeutics’ Hematopoietic Differentiation Platform

Fate Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on cell-based therapies, has filed a patent covering a platform for differentiating pluripotent stem cells into blood-forming hematopoietic cells. The invention provides culture methods and media that enable the generation of therapeutic blood cell types without the use of embryoid body formation – a significant technical advance that simplifies manufacturing and opens new possibilities for off-the-shelf cell therapies.

The Problem

The immune system depends on a continuous supply of specialised blood cells – T cells, natural killer (NK) cells, B cells and their progenitors – to fight infection, recognise cancer and maintain immune surveillance. In patients with haematological cancers, immune deficiencies or conditions requiring bone marrow transplantation, the ability to provide or restore these cell populations is critical to treatment success.

The emerging field of cell therapy aims to produce therapeutic quantities of immune cells that can be given to patients to enhance or restore immune function. One of the most promising approaches involves starting with induced pluripotent stem cells (iPSCs) – cells that have been reprogrammed to an embryonic-like state and can theoretically be directed to differentiate into virtually any cell type in the body. If iPSCs can be reliably differentiated into hematopoietic (blood-forming) cells, they could serve as a virtually unlimited source of therapeutic immune cells for use in treating cancer, immune disease and a range of other conditions.

The problem is that current methods for differentiating pluripotent stem cells into hematopoietic cells are technically complex and difficult to scale for manufacturing. Many established protocols require the formation of embryoid bodies (EBs) – three-dimensional cell aggregates that recapitulate early embryonic development. EB formation is technically variable, difficult to control reproducibly and does not lend itself to the large-scale, high-throughput manufacturing processes needed to produce cell therapies for widespread clinical use. Additionally, many protocols require complex feeder cell systems or ill-defined culture conditions that introduce variability and regulatory complexity.

What This Invention Does

Fate Therapeutics’ invention provides culture platforms, cell media and differentiation methods that can direct pluripotent stem cells to become hematopoietic cells – including induced hematopoietic stem cells (iHSCs), definitive hemogenic endothelium, hematopoietic multipotent progenitors, T cell progenitors, NK cell progenitors, T cells, NK cells, NKT cells and B cells – without requiring embryoid body formation.

The key innovation is a feed-free, monolayer culture system. Rather than growing cells in suspension as embryoid body aggregates, the cells are maintained as a flat monolayer on the culture surface, fed with defined media without the need for regular feeding changes or feeder cells. This approach is more reproducible, more scalable and easier to monitor than EB-based systems. It also produces a more homogeneous cell population because the differentiation signals can be applied uniformly to cells growing in a single layer rather than varying depending on a cell’s position within a three-dimensional aggregate.

The platform generates multiple hematopoietic cell types from the same starting iPSC population, with differentiation directed by the specific culture conditions and media compositions described in the patent. This versatility means the same fundamental technology can be used to produce T cells for CAR-T type therapies, NK cells for innate immune cell therapies, or progenitor cells for transplantation applications – all from a scalable, manufacturable source.

Key Features

Embryoid body-free differentiation. The platform generates hematopoietic cells from pluripotent stem cells without requiring embryoid body formation, eliminating a major source of technical variability and scalability limitation.

Feed-free monolayer culture. Cells are grown as a flat monolayer without regular feeding changes or feeder cell requirements, simplifying manufacturing, reducing variability and enabling more straightforward scale-up.

Multiple cell type generation. The platform is capable of producing a broad range of hematopoietic cell types including iHSCs, NK cells, T cells, NKT cells, B cells and various progenitor populations, reflecting the versatility of the differentiation methods.

Defined culture media. The invention specifies culture media compositions designed to support hematopoietic differentiation under the monolayer conditions, providing defined and reproducible inputs that support clinical and regulatory requirements.

iPSC-derived cell therapies. The downstream application of the platform is the production of iPSC-derived immune cells for therapeutic use – the foundation of Fate Therapeutics’ off-the-shelf cell therapy pipeline.

Who Is Behind It?

Fate Therapeutics, Inc. is a San Diego-based clinical-stage biopharmaceutical company pioneering the development of off-the-shelf cell therapies derived from clonal master iPSC lines. The company’s approach uses iPSCs as a renewable, standardisable starting material for producing immune cell therapies that do not require patient-specific cell collection. The inventors named are Bahram Valamehr, Raedun Clarke and Ryan Bjordahl – key members of Fate Therapeutics’ scientific leadership team. This application is a divisional of AU 2023203874, which itself traces back to an original application filed in July 2016, reflecting a decade-long programme of stem cell research and development. The patent is filed through Spruson and Ferguson.

Why It Matters

The promise of iPSC-derived cell therapies is enormous, but realising that promise depends on solving the manufacturing challenges. Current autologous cell therapies – where cells are collected from each individual patient, engineered and returned – are extraordinarily expensive and logistically complex, limiting their accessibility and scalability. Off-the-shelf approaches, using standardised iPSC-derived cells produced in advance and stored for use when needed, could transform the economics and accessibility of cell therapy.

A differentiation platform that is feed-free, EB-free and capable of producing multiple therapeutic cell types from a common manufacturing process is a critical enabler of this vision. It represents progress not just in basic stem cell biology but in the practical requirements of industrial cell therapy manufacturing. As regulatory agencies in Australia, the United States and elsewhere continue to grapple with how to evaluate and approve cell-based medicines, inventions like this one – which improve reproducibility and scalability while maintaining biological efficacy – will be central to getting life-saving therapies to more patients, faster and at lower cost.

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AU 2026201575 was published in the Australian Official Journal of Patents on 19 March 2026 and is open for public inspection. Patent applications represent inventions that are sought to be protected and do not necessarily reflect commercially available products.