Inactivated human platelet lysate with psoralen: a new perspective for mesenchymal stromal cell production in Good Manufacturing Practice conditions

Castiglia, Sara; Mareschi, Katia; Labanca, Luciana; Lucania, Graziella; Leone, Marco; Sanavio, Fiorella; Castello, Laura; Rustichelli, Deborah; Signorino, Elena; Gunetti, Monica; Bergallo, Massimiliano; Bordiga, Anna Maria; Ferrero, Ivana; Fagioli, Franca

doi:10.1016/j.jcyt.2013.12.008

Cited by 59 publications

(78 citation statements)

References 54 publications

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“…Overall, different protocols were developed and tested to obtain a FBS substitute able to maintain MSC in vitro, preserving stemness and multipotency (103,105). VBD were promissors as FBS substitutes, since senescence (68,106) or Karyotype/ chromosomal alteration were not detected in MSC expanded in VBD (13,23,(107)(108)(109). In addition, clinical studies strengthened such evidence by reporting none malign transformation in vivo (96,99,101,102).…”

Section: Discussionmentioning

confidence: 99%

“…Despite blood of umbilical cord possess a higher amount of growth factors (platelet-derived growth factors -PDGF, fibroblast growth factor 2 -FGF-2 and vascular endothelial growth factor -VEGF) when compared to venous blood, the application of blood from umbilical cord is restricted due the difficult to obtain large volumes (12,(21)(22)(23). Besides, the growth factors concentration found in different VBD (12,22,110) was reported as higher than in FBS (22,41,43,111).…”

Section: Discussionmentioning

confidence: 99%

“…Venous blood is a source that can be easily obtained in a large volume from blood banks or from the own patient, decreasing the barriers for the use of SC-BT (2,8,9). In contrast, umbilical cord blood is more difficult to obtain donors and provide few volume of blood available (12,(21)(22)(23). Therefore, VBD presetting an important source easily accessed to clinicians providing a potential xeno-free supplementation for MSC expansion (24,25).…”

Section: Introductionmentioning

confidence: 99%

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Venous Blood Derivatives as FBS-Substitutes for Mesenchymal Stem Cells: A Systematic Scoping Review

et al. 2017

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Although the biological properties of mesenchymal stem cells (MSC) are well-characterized in vitro, MSC clinical application is still far away to be achieved, mainly due to the need of xenogeneic substances for cell expansion, such as fetal bovine serum (FBS). FBS presents risks regarding pathogens transmissions and internalization of animal's proteins, which can unleash antigenic responses in patients after MSC implantation. A wide range of venous blood derivatives (VBD) has been reported as FBS substitutes showing promising results. Thus, the aim of this study was to conduct a systematic scoping review to analyze whether VBD are effective FBS substitutes for MSC ex vivo expansion. The search was performed in SciVerse Scopus TM , PubMed, Web of Science TM , BIREME, Cochrane library up to January 2016. The keywords were selected using MeSH and entry terms. Two independent reviewers scrutinized the records obtained considering specific inclusion criteria. The included studies were evaluated in accordance with a modified Arksey and O' Malley's framework. From 184 found studies, 90 were included. Bone marrow mesenchymal stem cells (BMMSC) were presented in most of these studies. Overall, VBD allowed for either, maintenance of MCS's fibroblast-like morphology, high proliferation, high colony-formation ability and maintenance of multipotency. Besides. MSC expanded in VBD supplements presented higher mitogen activity than FBS. VBD seems to be excellent xeno-free serum for ex vivo expansion of mesenchymal stem cells. However, an accentuated heterogeneity was observed between the carried out protocols for VBD isolation did not allowing for direct comparisons between the included studies.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Venous Blood Derivatives as FBS-Substitutes for Mesenchymal Stem Cells: A Systematic Scoping Review

et al. 2017

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“…The final published version may differ from this proof. However, as the use of human-derived blood materials leads to immunologic and infectious risks, the application of the Pathogen Inactivation is safe and the inactivated HPL represents a good, GMP-compliant alternative to FBS [34]. This is because it reduces manipulation and haematopoietic contamination (cellular growth) and represents a good procedure for MSC expansion for clinical use [35][36].…”

Section: Isolation and Expansion Of Mesenchymal Stromal Cells (Mscs)mentioning

confidence: 99%

Ex Vivo Expanded Mesenchymal Stromal Cell Minimal Quality Requirements for Clinical Application

Torre

Lucarelli

GuidiSimona³

et al. 2015

Stem Cells and Development

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Mesenchymal Stromal Cells (MSC), as advanced therapy products, must satisfy all the requirements for human use of medicinal products, aiming to maintain the quality and safety of the cells. The MSC manufacturing process for clinical use should comply with the principles of Good Manufacturing Practice (GMP). This ensures that cell preparations are produced and controlled, from the collection and manipulation of raw materials, through the processing of intermediate products, to the quality controls, storage, labelling and packaging, and release.The objective of this document is to provide the minimal quality requirements for the MSC production and its delivery for clinical use, so the safety of the final cell therapy product will not be compromised. For this purpose, the document evaluates the most important steps of GMP-compliant MSC production: the isolation and expansion process; the validation phase of the process, including all quality controls for the characterization, functionality, potency and safety of MSCs; the quality control at the batch release to guarantee the safety of patient infusion. This opinion paper reflects the consensus viewpoint of the authors and scientists participating the GISM Working Group*.

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“…Concentrates are stored until the donors have donated blood for a second time and have again tested negative for infectious markers. A second approach, which is currently being investigated, is the use of pathogen reduction/inactivation (Castiglia et al, 2014;Jonsdottir-Buch et al, 2015;Shih et al, 2011;Ståhle et al, 2010).…”

Section: Alternatives To Fbsmentioning

confidence: 99%

Fetal bovine serum (FBS): Past – present – future

Valk

Bieback

Buta³

et al. 2018

ALTEX

266

222

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Inactivated human platelet lysate with psoralen: a new perspective for mesenchymal stromal cell production in Good Manufacturing Practice conditions

Abstract: Background: Mesenchymal Stem Cells (MSC) are ideal candidates for regenerative and

Cited by 59 publications

References 54 publications

Venous Blood Derivatives as FBS-Substitutes for Mesenchymal Stem Cells: A Systematic Scoping Review

Venous Blood Derivatives as FBS-Substitutes for Mesenchymal Stem Cells: A Systematic Scoping Review

Ex Vivo Expanded Mesenchymal Stromal Cell Minimal Quality Requirements for Clinical Application

Fetal bovine serum (FBS): Past – present – future

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