Mesenchymal stromal cell therapy: progress in manufacturing and assessments of potency

Robb, Kevin P.; Fitzgerald, Joan; Barry, Frank; Viswanathan, Sowmya

doi:10.1016/j.jcyt.2018.10.014

Cited by 119 publications

(113 citation statements)

References 108 publications

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“…To scale MSC‐sEV production, bioreactors may be required. Three main bioreactor types are currently available, each uniquely affecting sEV‐producing MSCs: bioreactors with expanded 2D surfaces, hollow fibre‐based bioreactors, and stirred‐tank bioreactors (in which MSCs must be grown on appropriate microcarriers) [29]. Although each has been used for MSC expansion, their impact on sEV production and function requires further investigation.…”

Section: Extracellular Vesicles: Definitions and Considerationsmentioning

confidence: 99%

Defining mesenchymal stromal cell (MSC)‐derived small extracellular vesicles for therapeutic applications

Witwer

Balkom

Bruno

et al. 2019

J of Extracellular Vesicle

461

413

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Small extracellular vesicles (sEVs) from mesenchymal stromal/stem cells (MSCs) are transiting rapidly towards clinical applications. However, discrepancies and controversies about the biology, functions, and potency of MSC-sEVs have arisen due to several factors: the diversity of MSCs and their preparation; various methods of sEV production and separation; a lack of standardized quality assurance assays; and limited reproducibility of in vitro and in vivo functional assays. To address these issues, members of four societies (SOCRATES, ISEV, ISCT and ISBT) propose specific harmonization criteria for MSC-sEVs to facilitate data sharing and comparison, which should help to advance the field towards clinical applications. Specifically, MSC-sEVs should be defined by quantifiable metrics to identify the cellular origin of the sEVs in a preparation, presence of lipid-membrane vesicles, and the degree of physical and biochemical integrity of the vesicles. For practical purposes, new MSC-sEV preparations might also be measured against a well-characterized MSC-sEV biological reference. The ultimate goal of developing these metrics is to map aspects of MSC-sEV biology and therapeutic potency onto quantifiable features of each preparation.

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Section: Extracellular Vesicles: Definitions and Considerationsmentioning

confidence: 99%

Defining mesenchymal stromal cell (MSC)‐derived small extracellular vesicles for therapeutic applications

Witwer

Balkom

Bruno

et al. 2019

J of Extracellular Vesicle

461

413

View full text Add to dashboard Cite

show abstract

“…In addition, critical and clear phenotypic parameters for defining MSCs are uncertain and a coherent biological framework surrounding the therapeutic mechanism of action is not yet available . Added to this, cell manufacturing protocols are complex and costly and present substantial challenges in terms of regulatory oversight and standardization . Despite these obstacles, MSCs still remain at the forefront of efforts in Regenerative Medicine, based on a conviction that this technology can provide an effective treatment paradigm for major diseases where there is still an unmet need.…”

Section: Mscsmentioning

confidence: 99%

“…4 Added to this, cell manufacturing protocols are complex and costly and present substantial challenges in terms of regulatory oversight and standardization. 5 Despite these obstacles, MSCs still remain at the forefront of efforts in Regenerative Medicine, based on a conviction that this technology can provide an effective treatment paradigm for major diseases where there is still an unmet need. Progress has been made, although at a pace much slower than anticipated.…”

mentioning

confidence: 99%

MSC Therapy for Osteoarthritis: An Unfinished Story

Barry

2019

Journal Orthopaedic Research

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Mesenchymal stromal cells (MSCs) have firmly occupied the attention of orthopedic clinicians and scientists for most of the last 25 years. Hundreds of laboratories worldwide have carried out research aimed at unraveling the biological characteristics of these cells and probing the manner in which they potentially contribute to cartilage and bone repair. Clinical trials registries indicate that they are also being tested in patient studies for a wide range of conditions such as osteoarthritis, rheumatoid arthritis, fracture repair, regeneration of articular cartilage, tendon repair, and for treatment of degenerative disc disease. Despite these efforts, the effectiveness of MSCs as a treatment modality for these conditions is still uncertain and market authorizations have been limited. In addition, critical and clear phenotypic parameters for defining MSCs are uncertain and a coherent biological framework surrounding the therapeutic mechanism of action is not yet available. Added to this, cell manufacturing protocols are complex and costly and present substantial challenges in terms of regulatory oversight and standardization. Despite these obstacles, MSCs still remain at the forefront of efforts in Regenerative Medicine, based on a conviction that this technology can provide an effective treatment paradigm for major diseases where there is still an unmet need. © 2019 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 37:1229–1235, 2019.

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“…To minimise these inconsistencies, the International Society for Cellular Therapy (ISCT) issued a position statement in 2006 to propose the minimal criteria to define human MSCs [11]. While these criteria are useful for describing MSC purity in growing adherent cultures, additional potency assays are needed in order to predict clinically important factors such as MSC differentiation and immunomodulation capabilities, as well as growth factor production [10,12].…”

Section: Introductionmentioning

confidence: 99%

Identification of senescent cells in multipotent mesenchymal stromal cell cultures: Current methods and future directions

et al. 2019

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Mesenchymal stromal cell therapy: progress in manufacturing and assessments of potency

Cited by 119 publications

References 108 publications

Defining mesenchymal stromal cell (MSC)‐derived small extracellular vesicles for therapeutic applications

Defining mesenchymal stromal cell (MSC)‐derived small extracellular vesicles for therapeutic applications

MSC Therapy for Osteoarthritis: An Unfinished Story

Identification of senescent cells in multipotent mesenchymal stromal cell cultures: Current methods and future directions

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