Academic Journal

Stem Cell Therapies for Gastrointestinal and Liver Diseases: Translational Barriers, Clinical Heterogeneity, and Future Directions.

Bibliographic Details
Title: Stem Cell Therapies for Gastrointestinal and Liver Diseases: Translational Barriers, Clinical Heterogeneity, and Future Directions.
Authors: Nikolaev, Georgi, Lozenov, Stefan, Konaktchieva, Marina, Arabadzhiev, Borislav, Vassileva, Ivelina, Sotirov, Radko, Konakchieva, Rossitza
Source: Biomedicines; May2026, Vol. 14 Issue 5, p1102, 21p
Subject Terms: Mesenchymal stem cells, Liver diseases, Organoids, Stem cell treatment, Induced pluripotent stem cells, Extracellular vesicles, Gastrointestinal diseases
Abstract: Gastrointestinal and liver diseases remain major contributors to global morbidity and mortality, with limited options for curative or regenerative treatment. Innovative cell-based platforms for liver regeneration and treatment include advanced therapy medicinal products (ATMPs) based on mesenchymal stem cells (MSCs), induced pluripotent stem cells (iPSCs), and organoids produced by them, while cell-free systems like extracellular vesicles (EVs) offer a new approach to restore tissue function and homeostasis. This review summarizes key advances from 2020 to 2025 in the translational development of these platforms. MSCs have achieved clinical validation in perianal Crohn's disease and show encouraging antifibrotic and immunomodulatory effects in cirrhosis and acute-on-chronic liver failure. iPSC and iPSC-derived organoids now enable disease modeling and, in early trials, have shown direct epithelial repair. Emerging cell-free approaches based on EVs promise safer, scalable products. Despite rapid progress, challenges remain in potency standardization, manufacturing, and long-term efficacy assessment. International harmonization through the EMA, FDA, and PMDA frameworks is accelerating the translation of stem cell-based advanced therapy medicinal products. The integration of bioengineering, data science, and ethical governance will determine whether these regenerative approaches evolve into accessible standard-of-care interventions for gastrointestinal and hepatic diseases. [ABSTRACT FROM AUTHOR]
Copyright of Biomedicines is the property of MDPI and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Complementary Index
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  Data: Stem Cell Therapies for Gastrointestinal and Liver Diseases: Translational Barriers, Clinical Heterogeneity, and Future Directions.
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  Data: <searchLink fieldCode="AR" term="%22Nikolaev%2C+Georgi%22">Nikolaev, Georgi</searchLink><br /><searchLink fieldCode="AR" term="%22Lozenov%2C+Stefan%22">Lozenov, Stefan</searchLink><br /><searchLink fieldCode="AR" term="%22Konaktchieva%2C+Marina%22">Konaktchieva, Marina</searchLink><br /><searchLink fieldCode="AR" term="%22Arabadzhiev%2C+Borislav%22">Arabadzhiev, Borislav</searchLink><br /><searchLink fieldCode="AR" term="%22Vassileva%2C+Ivelina%22">Vassileva, Ivelina</searchLink><br /><searchLink fieldCode="AR" term="%22Sotirov%2C+Radko%22">Sotirov, Radko</searchLink><br /><searchLink fieldCode="AR" term="%22Konakchieva%2C+Rossitza%22">Konakchieva, Rossitza</searchLink>
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  Data: Biomedicines; May2026, Vol. 14 Issue 5, p1102, 21p
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  Data: <searchLink fieldCode="DE" term="%22Mesenchymal+stem+cells%22">Mesenchymal stem cells</searchLink><br /><searchLink fieldCode="DE" term="%22Liver+diseases%22">Liver diseases</searchLink><br /><searchLink fieldCode="DE" term="%22Organoids%22">Organoids</searchLink><br /><searchLink fieldCode="DE" term="%22Stem+cell+treatment%22">Stem cell treatment</searchLink><br /><searchLink fieldCode="DE" term="%22Induced+pluripotent+stem+cells%22">Induced pluripotent stem cells</searchLink><br /><searchLink fieldCode="DE" term="%22Extracellular+vesicles%22">Extracellular vesicles</searchLink><br /><searchLink fieldCode="DE" term="%22Gastrointestinal+diseases%22">Gastrointestinal diseases</searchLink>
– Name: Abstract
  Label: Abstract
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  Data: Gastrointestinal and liver diseases remain major contributors to global morbidity and mortality, with limited options for curative or regenerative treatment. Innovative cell-based platforms for liver regeneration and treatment include advanced therapy medicinal products (ATMPs) based on mesenchymal stem cells (MSCs), induced pluripotent stem cells (iPSCs), and organoids produced by them, while cell-free systems like extracellular vesicles (EVs) offer a new approach to restore tissue function and homeostasis. This review summarizes key advances from 2020 to 2025 in the translational development of these platforms. MSCs have achieved clinical validation in perianal Crohn's disease and show encouraging antifibrotic and immunomodulatory effects in cirrhosis and acute-on-chronic liver failure. iPSC and iPSC-derived organoids now enable disease modeling and, in early trials, have shown direct epithelial repair. Emerging cell-free approaches based on EVs promise safer, scalable products. Despite rapid progress, challenges remain in potency standardization, manufacturing, and long-term efficacy assessment. International harmonization through the EMA, FDA, and PMDA frameworks is accelerating the translation of stem cell-based advanced therapy medicinal products. The integration of bioengineering, data science, and ethical governance will determine whether these regenerative approaches evolve into accessible standard-of-care interventions for gastrointestinal and hepatic diseases. [ABSTRACT FROM AUTHOR]
– Name: Abstract
  Label:
  Group: Ab
  Data: <i>Copyright of Biomedicines is the property of MDPI and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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RecordInfo BibRecord:
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      – Type: doi
        Value: 10.3390/biomedicines14051102
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      – Code: eng
        Text: English
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        PageCount: 21
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    Subjects:
      – SubjectFull: Mesenchymal stem cells
        Type: general
      – SubjectFull: Liver diseases
        Type: general
      – SubjectFull: Organoids
        Type: general
      – SubjectFull: Stem cell treatment
        Type: general
      – SubjectFull: Induced pluripotent stem cells
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      – SubjectFull: Extracellular vesicles
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      – SubjectFull: Gastrointestinal diseases
        Type: general
    Titles:
      – TitleFull: Stem Cell Therapies for Gastrointestinal and Liver Diseases: Translational Barriers, Clinical Heterogeneity, and Future Directions.
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            NameFull: Nikolaev, Georgi
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              M: 05
              Text: May2026
              Type: published
              Y: 2026
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