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Acute Toxicity Evaluation and Safety Study of Allogeneic Wharton’s Jelly-Derived Mesenchymal Stromal Cells Therapy in the Animal Model

Received: 16 March 2022     Accepted: 11 April 2022     Published: 12 May 2022
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Abstract

In-vitro and in-vivo investigations using ex vivo-expanded human Wharton’s jelly-derived mesenchymal stromal cells (WJMSCs) isolated from single donors has shown therapeutic advantages. Clinical grade expansion, safety, and acute toxicity of Wharton’s jelly-derived mesenchymal stromal cells isolated from five healthy donors were evaluated in Wistar Albino Rats via intravenous and subcutaneous routes in this study. The expression of several cell surface markers, differentiation capacity, and immunomodulatory activities of the isolated WJMSCs were all evaluated. In a series of preclinical investigations, the clinical grade expanded cells were given to rodents by intravenous and subcutaneous methods to examine their in-vivo safety, overall toxicity, and tumorigenic potential. We confirmed that WJ cells exhibit morphological and phenotypic features that are comparable to MSCs. In rats, the study found no mortality, aberrant clinical symptoms, or significant pathological alterations at varied dosages administered intravenously or subcutaneously. Furthermore, rats tolerated repeated treatment of WJMSCs well, with no evidence of prenatal harm in the same animal species. The WJMSCs were shown to be non-toxic, non-teratogenic, and non-tumorigenic in Wistar Albino Rats. More research is needed to see if it can be safely supplied to human patients.

Published in Rehabilitation Science (Volume 7, Issue 2)
DOI 10.11648/j.rs.20220702.12
Page(s) 20-28
Creative Commons

This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.

Copyright

Copyright © The Author(s), 2022. Published by Science Publishing Group

Keywords

Wharton's Jelly, Umbilical Cord Mesenchymal Stromal Cells, Intravenous, Subcutaneous, Safety, Toxicity

References
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Cite This Article
  • APA Style

    Jaianand Kannaiyan, Pavankumar Shukla, Firdosh Mahuvawalla. (2022). Acute Toxicity Evaluation and Safety Study of Allogeneic Wharton’s Jelly-Derived Mesenchymal Stromal Cells Therapy in the Animal Model. Rehabilitation Science, 7(2), 20-28. https://doi.org/10.11648/j.rs.20220702.12

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    ACS Style

    Jaianand Kannaiyan; Pavankumar Shukla; Firdosh Mahuvawalla. Acute Toxicity Evaluation and Safety Study of Allogeneic Wharton’s Jelly-Derived Mesenchymal Stromal Cells Therapy in the Animal Model. Rehabil. Sci. 2022, 7(2), 20-28. doi: 10.11648/j.rs.20220702.12

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    AMA Style

    Jaianand Kannaiyan, Pavankumar Shukla, Firdosh Mahuvawalla. Acute Toxicity Evaluation and Safety Study of Allogeneic Wharton’s Jelly-Derived Mesenchymal Stromal Cells Therapy in the Animal Model. Rehabil Sci. 2022;7(2):20-28. doi: 10.11648/j.rs.20220702.12

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  • @article{10.11648/j.rs.20220702.12,
      author = {Jaianand Kannaiyan and Pavankumar Shukla and Firdosh Mahuvawalla},
      title = {Acute Toxicity Evaluation and Safety Study of Allogeneic Wharton’s Jelly-Derived Mesenchymal Stromal Cells Therapy in the Animal Model},
      journal = {Rehabilitation Science},
      volume = {7},
      number = {2},
      pages = {20-28},
      doi = {10.11648/j.rs.20220702.12},
      url = {https://doi.org/10.11648/j.rs.20220702.12},
      eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.rs.20220702.12},
      abstract = {In-vitro and in-vivo investigations using ex vivo-expanded human Wharton’s jelly-derived mesenchymal stromal cells (WJMSCs) isolated from single donors has shown therapeutic advantages. Clinical grade expansion, safety, and acute toxicity of Wharton’s jelly-derived mesenchymal stromal cells isolated from five healthy donors were evaluated in Wistar Albino Rats via intravenous and subcutaneous routes in this study. The expression of several cell surface markers, differentiation capacity, and immunomodulatory activities of the isolated WJMSCs were all evaluated. In a series of preclinical investigations, the clinical grade expanded cells were given to rodents by intravenous and subcutaneous methods to examine their in-vivo safety, overall toxicity, and tumorigenic potential. We confirmed that WJ cells exhibit morphological and phenotypic features that are comparable to MSCs. In rats, the study found no mortality, aberrant clinical symptoms, or significant pathological alterations at varied dosages administered intravenously or subcutaneously. Furthermore, rats tolerated repeated treatment of WJMSCs well, with no evidence of prenatal harm in the same animal species. The WJMSCs were shown to be non-toxic, non-teratogenic, and non-tumorigenic in Wistar Albino Rats. More research is needed to see if it can be safely supplied to human patients.},
     year = {2022}
    }
    

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    T1  - Acute Toxicity Evaluation and Safety Study of Allogeneic Wharton’s Jelly-Derived Mesenchymal Stromal Cells Therapy in the Animal Model
    AU  - Jaianand Kannaiyan
    AU  - Pavankumar Shukla
    AU  - Firdosh Mahuvawalla
    Y1  - 2022/05/12
    PY  - 2022
    N1  - https://doi.org/10.11648/j.rs.20220702.12
    DO  - 10.11648/j.rs.20220702.12
    T2  - Rehabilitation Science
    JF  - Rehabilitation Science
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    AB  - In-vitro and in-vivo investigations using ex vivo-expanded human Wharton’s jelly-derived mesenchymal stromal cells (WJMSCs) isolated from single donors has shown therapeutic advantages. Clinical grade expansion, safety, and acute toxicity of Wharton’s jelly-derived mesenchymal stromal cells isolated from five healthy donors were evaluated in Wistar Albino Rats via intravenous and subcutaneous routes in this study. The expression of several cell surface markers, differentiation capacity, and immunomodulatory activities of the isolated WJMSCs were all evaluated. In a series of preclinical investigations, the clinical grade expanded cells were given to rodents by intravenous and subcutaneous methods to examine their in-vivo safety, overall toxicity, and tumorigenic potential. We confirmed that WJ cells exhibit morphological and phenotypic features that are comparable to MSCs. In rats, the study found no mortality, aberrant clinical symptoms, or significant pathological alterations at varied dosages administered intravenously or subcutaneously. Furthermore, rats tolerated repeated treatment of WJMSCs well, with no evidence of prenatal harm in the same animal species. The WJMSCs were shown to be non-toxic, non-teratogenic, and non-tumorigenic in Wistar Albino Rats. More research is needed to see if it can be safely supplied to human patients.
    VL  - 7
    IS  - 2
    ER  - 

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Author Information
  • Research and Development, Cell Cure Therapeutics, Coimbatore, India

  • Regeneracion Corporation, Vigan City, Philippines

  • Regeneracion Corporation, Vigan City, Philippines

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