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New iPSC Lines Created for Clinical Development

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iPSCs have been created using mRNA technologies, with cGMP control from donor screening, consenting, to skin punch, and throughout cell bank production.

iPSC production
1, iPSC colonies appear among fibroblasts; 2, isolated tight iPSC colony; 3, established iPSC 2D culture

SAN DIEGO, CA, USA, December 4, 2018 — After 3 years of cleanroom construction and 2 years of quality system establishment, Allele Biotech has produced its initial batch of 6 iPSC (induced pluripotent stem cells) lines that are ready for prime time. [Read more…]

iPSC Market Accelerated by Clinical Studies in Japan, Australia, UK, and U.S.

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Growth of the iPSC market is supported by an increasing number of clinical studies that are investigating the therapeutic potential of iPSC-derived cell therapy products. Induced pluripotent stem cells (called iPSCs or iPS cells) are a type of stem cell that can become any cell within the human body, giving them enormous potential for use within regenerative medicine. [Read more…]

Stem Cell Treatment for Parkinson’s Disease

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At least eight clinical trials worldwide and one physician-led study in Japan are exploring stem cells as a treatment approach to Parkinson’s disease. This research progress is critical, because the disease debilitates the body and causes tremors and numbness, loss of motor function, and stooping. Eventually, left untreated, Parkinson’s disease leads to death. The good news is, researchers are showing significant results in their studies on the link between stem cells and Parkinson’s disease.

In this article:

  1. An Introduction to Stem Cells
  2. What Are Stem Cells?
  3. What Is Parkinson’s Disease?
  4. How Does Stem Cell Therapy Work?
  5. How Can Stem Cells Help Heal This Condition?
  6. Clinical Study in Japan for Parkinson’s Disease
  7. Are We Close to a Widespread Solution?

[Read more…]

Fate Therapeutics Announces FDA Clearance of Landmark IND for FT500 iPSC-derived, Off-the-Shelf NK Cell Cancer Immunotherapy

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Company to Initiate First-ever U.S. Clinical Investigation of iPSC-derived Cell Product

FT500 to be Featured in Oral Presentation on Monday, December 3 at ASH Annual Meeting

SAN DIEGO, Nov. 30, 2018  — Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, announced today that the U.S. Food and Drug Administration (FDA) has allowed its Investigational New Drug (IND) Application for FT500, the Company’s universal, off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line. [Read more…]

Evotec to Pair Its iPSC Platform for Drug Discovery with Immuneering’s AI Technology

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Induced pluripotent stem cells are a type of pluripotent stem cell that can be created from differentiated (“adult”) cells. iPSCs are increasingly being explored for applications within drug development and discovery. This is because patient-derived somatic cells (for example, fibroblasts) can be reprogrammed to produce iPSCs that have disease-specific genetic aberrations. These cells can then be differentiated into the disease-affected cell type (for example, neurons in neurodegenerative diseases). [Read more…]

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