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Related Concept Videos

iPS Cell Differentiation01:22

iPS Cell Differentiation

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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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After cellular or tissue damage, the resident stem cells present in the human body can locally repair and regenerate the damaged tissue or organ. However, even though some tissues do not have stem cells, they can repair and regenerate with the help of pre-existing cells. For example, beta cells of the pancreas and hepatocytes of the liver can divide to renew and regenerate the tissue. Here, both cell division and cell death are well regulated by homeostasis.
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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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EPS and iPS Cells in Disease Research01:21

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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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Updated: Sep 18, 2025

Differentiation of Human Pluripotent Stem Cells into Insulin-Producing Islet Clusters
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Stem Cell-Derived, Fully Differentiated Islets for Type 1 Diabetes.

Trevor W Reichman1, James F Markmann2, Jon Odorico3

  • 1Toronto General Hospital, University Health Network, University of Toronto, Toronto.

The New England Journal of Medicine
|June 22, 2025
PubMed
Summary
This summary is machine-generated.

Zimislecel, a novel stem cell therapy, shows promise in restoring islet function for type 1 diabetes patients. Early results indicate improved glucose control and insulin independence, warranting further study.

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Area of Science:

  • Regenerative Medicine
  • Endocrinology
  • Immunology

Background:

  • Type 1 diabetes (T1D) is an autoimmune disease characterized by the destruction of insulin-producing beta cells.
  • Current management relies on exogenous insulin, which has limitations in achieving optimal glycemic control and preventing complications.
  • Allogeneic stem cell-derived islet-cell therapy offers a potential alternative for restoring endogenous insulin production.

Purpose of the Study:

  • To evaluate the safety and efficacy of zimislecel in individuals with type 1 diabetes.
  • To assess the potential of zimislecel to restore physiologic islet function and improve glycemic control.

Main Methods:

  • A Phase 1-2 clinical trial involving participants with type 1 diabetes.
  • Administration of zimislecel (half or full dose) via portal vein infusion.
  • Participants received glucocorticoid-free immunosuppressive therapy.
  • Primary endpoints included safety, freedom from severe hypoglycemia, and glycated hemoglobin levels.
  • Secondary endpoints included insulin independence and assessment of islet function via C-peptide detection.

Main Results:

  • All participants showed evidence of engraftment and islet function post-infusion, indicated by detectable C-peptide levels.
  • The majority of participants in the full-dose groups achieved freedom from severe hypoglycemia and maintained glycated hemoglobin below 7%.
  • 83% of participants in the full-dose groups achieved insulin independence by day 365.
  • Neutropenia was the most common serious adverse event; two deaths occurred, unrelated to the study drug.

Conclusions:

  • Zimislecel demonstrates potential in restoring physiologic islet function in individuals with type 1 diabetes.
  • The findings support the continued clinical investigation of zimislecel as a therapeutic option for T1D.
  • Further research is warranted to confirm these preliminary results in larger, long-term studies.