@misc{10481/58740,
year = {2019},
month = {10},
url = {http://hdl.handle.net/10481/58740},
abstract = {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.},
organization = {This work was supported by Ministerio de Ciencia, Innovación y Universidades. Plan Estatal I+D+I,
Grant Number: RTI2018-095410-B-100; Spanish Ministry of Economy (MINECO), Grant Number: RD16/0011/0030;
Spanish Ministry of Science, Innovation and Universities (to JAG) and by the Ministerio de Economía, Industria y
Competitividad (FEDER funds, project RTC-2016-5451-1) (to BC and PG-M). Additional it has been developed in
the context of AdvanceCat with the support of ACCIÓ (Catalonia Trade & Investment; Generalitat de Catalunya)
under the Catalonian European Regional Development Fund operational program, 2014-2020 (to PG-M).},
publisher = {MDPI},
keywords = {Mesenchymal stem cells},
keywords = {Good manufacturing practice},
keywords = {Cell characterization},
keywords = {Release criteria and manufacturing process},
title = {Principal Criteria for Evaluating the Quality, Safety and E cacy of hMSC-Based Products in Clinical Practice: Current Approaches and Challenges},
doi = {10.3390/pharmaceutics11110552},
author = {Guadix, Juan Antonio and Clares Naveros, Beatriz and Soriano Ruiz, José Luis and Gálvez Martín, P.},
}