Cargando…

Principal Criteria for Evaluating the Quality, Safety and Efficacy of hMSC-Based Products in Clinical Practice: Current Approaches and Challenges

Human Mesenchymal Stem Cells (hMSCs) play an important role as new therapeutic alternatives in advanced therapies and regenerative medicine thanks to their regenerative and immunomodulatory properties, and ability to migrate to the exact area of injury. These properties have made hMSCs one of the mo...

Descripción completa

Detalles Bibliográficos
Autores principales: Guadix, Juan Antonio, López-Beas, Javier, Clares, Beatriz, Soriano-Ruiz, José Luis, Zugaza, José Luis, Gálvez-Martín, Patricia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6921040/
https://www.ncbi.nlm.nih.gov/pubmed/31652984
http://dx.doi.org/10.3390/pharmaceutics11110552
_version_ 1783481072343842816
author Guadix, Juan Antonio
López-Beas, Javier
Clares, Beatriz
Soriano-Ruiz, José Luis
Zugaza, José Luis
Gálvez-Martín, Patricia
author_facet Guadix, Juan Antonio
López-Beas, Javier
Clares, Beatriz
Soriano-Ruiz, José Luis
Zugaza, José Luis
Gálvez-Martín, Patricia
author_sort Guadix, Juan Antonio
collection PubMed
description Human Mesenchymal Stem Cells (hMSCs) play an important role as new therapeutic alternatives in advanced therapies and regenerative medicine thanks to their regenerative and immunomodulatory properties, and ability to migrate to the exact area of injury. These properties have made hMSCs one of the more promising cellular active substances at present, particularly in terms of the development of new and innovative hMSC-based products. Currently, numerous clinical trials are being conducted to evaluate the therapeutic activity of hMSC-based products on specific targets. Given the rapidly growing number of hMSC clinical trials in recent years and the complexity of these products due to their cellular component characteristics and medicinal product status, there is a greater need to define more stringent, specific, and harmonized requirements to characterize the quality of the hMSCs and enhance the analysis of their safety and efficacy in final products to be administered to patients. These requirements should be implemented throughout the manufacturing process to guarantee the function and integrity of hMSCs and to ensure that the hMSC-based final product consistently meets its specifications across batches. This paper describes the principal phases involved in the design of the manufacturing process and updates the specific technical requirements needed to address the appropriate clinical use of hMSC-based products. The challenges and limitations to evaluating the safety, efficacy, and quality of hMSCs have been also reviewed and discussed.
format Online
Article
Text
id pubmed-6921040
institution National Center for Biotechnology Information
language English
publishDate 2019
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-69210402019-12-24 Principal Criteria for Evaluating the Quality, Safety and Efficacy of hMSC-Based Products in Clinical Practice: Current Approaches and Challenges Guadix, Juan Antonio López-Beas, Javier Clares, Beatriz Soriano-Ruiz, José Luis Zugaza, José Luis Gálvez-Martín, Patricia Pharmaceutics Review Human Mesenchymal Stem Cells (hMSCs) play an important role as new therapeutic alternatives in advanced therapies and regenerative medicine thanks to their regenerative and immunomodulatory properties, and ability to migrate to the exact area of injury. These properties have made hMSCs one of the more promising cellular active substances at present, particularly in terms of the development of new and innovative hMSC-based products. Currently, numerous clinical trials are being conducted to evaluate the therapeutic activity of hMSC-based products on specific targets. Given the rapidly growing number of hMSC clinical trials in recent years and the complexity of these products due to their cellular component characteristics and medicinal product status, there is a greater need to define more stringent, specific, and harmonized requirements to characterize the quality of the hMSCs and enhance the analysis of their safety and efficacy in final products to be administered to patients. These requirements should be implemented throughout the manufacturing process to guarantee the function and integrity of hMSCs and to ensure that the hMSC-based final product consistently meets its specifications across batches. This paper describes the principal phases involved in the design of the manufacturing process and updates the specific technical requirements needed to address the appropriate clinical use of hMSC-based products. The challenges and limitations to evaluating the safety, efficacy, and quality of hMSCs have been also reviewed and discussed. MDPI 2019-10-24 /pmc/articles/PMC6921040/ /pubmed/31652984 http://dx.doi.org/10.3390/pharmaceutics11110552 Text en © 2019 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Review
Guadix, Juan Antonio
López-Beas, Javier
Clares, Beatriz
Soriano-Ruiz, José Luis
Zugaza, José Luis
Gálvez-Martín, Patricia
Principal Criteria for Evaluating the Quality, Safety and Efficacy of hMSC-Based Products in Clinical Practice: Current Approaches and Challenges
title Principal Criteria for Evaluating the Quality, Safety and Efficacy of hMSC-Based Products in Clinical Practice: Current Approaches and Challenges
title_full Principal Criteria for Evaluating the Quality, Safety and Efficacy of hMSC-Based Products in Clinical Practice: Current Approaches and Challenges
title_fullStr Principal Criteria for Evaluating the Quality, Safety and Efficacy of hMSC-Based Products in Clinical Practice: Current Approaches and Challenges
title_full_unstemmed Principal Criteria for Evaluating the Quality, Safety and Efficacy of hMSC-Based Products in Clinical Practice: Current Approaches and Challenges
title_short Principal Criteria for Evaluating the Quality, Safety and Efficacy of hMSC-Based Products in Clinical Practice: Current Approaches and Challenges
title_sort principal criteria for evaluating the quality, safety and efficacy of hmsc-based products in clinical practice: current approaches and challenges
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6921040/
https://www.ncbi.nlm.nih.gov/pubmed/31652984
http://dx.doi.org/10.3390/pharmaceutics11110552
work_keys_str_mv AT guadixjuanantonio principalcriteriaforevaluatingthequalitysafetyandefficacyofhmscbasedproductsinclinicalpracticecurrentapproachesandchallenges
AT lopezbeasjavier principalcriteriaforevaluatingthequalitysafetyandefficacyofhmscbasedproductsinclinicalpracticecurrentapproachesandchallenges
AT claresbeatriz principalcriteriaforevaluatingthequalitysafetyandefficacyofhmscbasedproductsinclinicalpracticecurrentapproachesandchallenges
AT sorianoruizjoseluis principalcriteriaforevaluatingthequalitysafetyandefficacyofhmscbasedproductsinclinicalpracticecurrentapproachesandchallenges
AT zugazajoseluis principalcriteriaforevaluatingthequalitysafetyandefficacyofhmscbasedproductsinclinicalpracticecurrentapproachesandchallenges
AT galvezmartinpatricia principalcriteriaforevaluatingthequalitysafetyandefficacyofhmscbasedproductsinclinicalpracticecurrentapproachesandchallenges