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Related Concept Videos

EPS and iPS Cells in Disease Research01:21

EPS and iPS Cells in Disease Research

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Embryonic and induced pluripotent stem cells are excellent models for disease research because of their ability to self-renew and differentiate into most cell types. Somatic cells from a patient are isolated and reprogrammed into induced pluripotent stem cells or iPSCs. These iPSCs are later differentiated into the desired cell type, which mirrors the diseased cell of the patient. In this way, disease models have been created for investigating diseases such as Down syndrome, type I diabetes,...
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iPS Cell Differentiation01:22

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The ability of induced pluripotent stem cells or iPSCs to differentiate into most body cell types has stimulated repair and regenerative medicine research over the past few decades. iPSC-derived blood cells, hepatocytes, beta islet cells, cardiomyocytes, neurons, and other cell types can repair injuries or regenerate damaged tissue in diseases such as diabetes and neurodegenerative disorders.
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Induced Pluripotent Stem Cells01:13

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Stem cells are undifferentiated cells that divide and produce different types of cells. Ordinarily, cells that have differentiated into a specific cell type are post-mitotic—that is, they no longer divide. However, scientists have found a way to reprogram these mature cells so that they “de-differentiate” and return to an unspecialized, proliferative state. These cells are also pluripotent like embryonic stem cells—able to produce all cell types—and are therefore...
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Stem Cell Culture01:17

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Stem cell research aims to find ways to use stem cells to regenerate and repair cellular damage. Over time, most adult cells undergo the wear and tear of aging and lose their ability to divide and repair themselves. Stem cells do not display a particular morphology or function. Adult stem cells, which exist as a small subset of cells in most tissues, keep dividing and can differentiate into a number of specialized cells generally formed by that tissue. These cells enable the body to renew and...
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Embryonic Stem Cells00:57

Embryonic Stem Cells

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Embryonic stem (ES) cells were first discovered in mice in 1981 by Martin Evans. In 1998, James Thomson identified a method to isolate embryonic stem cells from humans. Human embryonic stem cells (hESCs) are obtained from 3-5 day old embryos that remain unused after an in vitro fertilization procedure.
ES cells are grown in a culture medium where they can divide indefinitely, creating ES cell lines. Under certain conditions, ES cells can differentiate, either spontaneously into a variety of...
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Human iPS Cells for Clinical Applications and Cellular Products.

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  • 1Centre for iPS Cell Research and Application (CiRA) and Institute for the Advanced Study of Human Biology (ASHBi), Kyoto University, Kyoto, Japan. moyra.lawrence@cira.kyoto-u.ac.jp.

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Human induced pluripotent stem cells (iPSCs) are versatile for cell therapy manufacturing. Quality control and good manufacturing practices are crucial for developing iPSC-derived treatments for diseases.

Keywords:
Clinical trialsGood manufacturing practiceInduced pluripotent stem cellPatient safetyRegulatory approval

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Area of Science:

  • Stem Cell Biology
  • Regenerative Medicine
  • Biotechnology

Background:

  • Human induced pluripotent stem cells (iPSCs) have become a preferred cell source for differentiating various mature cell types since 2007.
  • Their adaptability, gene-editing suitability, and functional similarity to embryonic stem cells facilitate their use in cellular product manufacturing.
  • iPSCs represent a significant advancement in cellular therapeutics.

Purpose of the Study:

  • To discuss the generation process of iPSCs.
  • To highlight essential quality control measures in iPSC manufacturing.
  • To review the application of good manufacturing practices (GMP) for iPSC production and clinical trials.

Main Methods:

  • Review of iPSC generation protocols.
  • Analysis of quality control strategies for cell manufacturing.
  • Examination of GMP implementation in biopharmaceutical production.
  • Survey of iPSC-derived cellular products in clinical trials.

Main Results:

  • iPSCs offer flexibility and functional equivalence to ESCs, driving their adoption in manufacturing.
  • Established quality control steps and GMP are vital for consistent iPSC production.
  • Several iPSC-derived cellular products are progressing through clinical trials.

Conclusions:

  • iPSCs are pivotal for next-generation cellular therapeutics.
  • Combining advanced differentiation, stringent quality control, and reproducible manufacturing enables iPSC-derived therapies.
  • These therapies hold promise for treating currently intractable diseases through large-scale, high-quality cell production.