Granjeiro JM, Borchio PGM, Ribeiro IPB, Paiva KBS. Bioengineering breakthroughs: The impact of stem cell models on advanced therapy medicinal product development. World J Stem Cells 2024; 16(10): 860-872 [PMID: 39493828 DOI: 10.4252/wjsc.v16.i10.860]
Corresponding Author of This Article
José Mauro Granjeiro, PhD, Senior Researcher, Division of Biological Metrology, The National Institute of Metrology, Quality, and Technology, Avenida Nossa Sra. das Graças, 50 - Xerém, Duque de Caxias 25250020, Rio de Janeiro, Brazil. jmgranjeiro@inmetro.gov.br
Research Domain of This Article
Cell & Tissue Engineering
Article-Type of This Article
Minireviews
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
World J Stem Cells. Oct 26, 2024; 16(10): 860-872 Published online Oct 26, 2024. doi: 10.4252/wjsc.v16.i10.860
Bioengineering breakthroughs: The impact of stem cell models on advanced therapy medicinal product development
José Mauro Granjeiro, Priscila Grion de Miranda Borchio, Icaro Paschoal Brito Ribeiro, Katiucia Batista Silva Paiva
José Mauro Granjeiro, Division of Biological Metrology, The National Institute of Metrology, Quality, and Technology, Duque de Caxias 25250020, Rio de Janeiro, Brazil
Priscila Grion de Miranda Borchio, Laboratory of Regenerative Medicine, Arthur Sá Earp Neto University, Petropolis 25680120, Rio de Janeiro, Brazil
Icaro Paschoal Brito Ribeiro, Katiucia Batista Silva Paiva, Laboratory of Extracellular Matrix Biology and Cellular Interaction, Department of Anatomy, Institute of Biomedical Sciences, University of São Paulo, São Paulo 05508000, São Paulo, Brazil
Co-corresponding authors: José Mauro Granjeiro and Katiucia Batista Silva Paiva.
Author contributions: Granjeiro JM and Paiva KBS contributed to this paper equally in design of the overall concept and outline of the manuscript, in writing and editing of the manuscript and generation of its illustrations, in reviewing the literature, and in securing of funding support, they are the co-corresponding authors of this manuscript; Borchio PGM and Ribeiro IPB made important intellectual contributions to the writing and editing of the manuscript and to the review of the literature. All authors read and approved the final draft of the manuscript.
Supported bySão Paulo Research Foundation/FAPESP, No. 2020/11564-6 and No. 2019/27001-3; the National Council for Scientific and Technological Development/CNPq, No. 400030/2018-7; and Network NanoHealth/FAPERJ, No. E-26/10.000981/2019 and No. E-26/010.000210/2019/FAPERJ.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: José Mauro Granjeiro, PhD, Senior Researcher, Division of Biological Metrology, The National Institute of Metrology, Quality, and Technology, Avenida Nossa Sra. das Graças, 50 - Xerém, Duque de Caxias 25250020, Rio de Janeiro, Brazil. jmgranjeiro@inmetro.gov.br
Received: April 30, 2024 Revised: July 22, 2024 Accepted: September 23, 2024 Published online: October 26, 2024 Processing time: 177 Days and 9.2 Hours
Abstract
The burgeoning field of bioengineering has witnessed significant strides due to the advent of stem cell models, particularly in their application in advanced therapy medicinal products (ATMPs). In this review, we examine the multifaceted impact of these developments, emphasizing the potential of stem cell models to enhance the sophistication of ATMPs and to offer alternatives to animal testing. Stem cell-derived tissues are particularly promising because they can reshape the preclinical landscape by providing more physiologically relevant and ethically sound platforms for drug screening and disease modelling. We also discuss the critical challenges of reproducibility and accuracy in measurements to ensure the integrity and utility of stem cell models in research and application. Moreover, this review highlights the imperative of stem cell models to align with regulatory standards, ensuring using stem cells in ATMPs translates into safe and effective clinical therapies. With regulatory approval serving as a gateway to clinical adoption, the collaborative efforts between scientists and regulators are vital for the progression of stem cell applications from bench to bedside. We advocate for a balanced approach that nurtures innovation within the framework of rigorous validation and regulatory compliance, ensuring that stem cell-base solutions are maximized to promote public trust and patient health in ATMPs.
Core Tip: Stem cells play a crucial role in tissue engineering by offering the potential for regenerating of damaged tissues, which is critical for developing advanced therapy medicinal products. Stem cells can differentiate into specific cell types and promote tissue repair through various mechanisms. When combined with tissue engineering techniques, stem cell therapy enhances cell viability, differentiation, and therapeutic efficacy, overcoming disease treatment limitations. However, translating stem cell research into approved clinical therapies has been challenging. Regulatory bodies have provided guidelines to ensure the safety and efficacy of advanced therapy medicinal products utilizing stem cells before the approval for clinical use.
