Should Publications on Mesenchymal Stem/Progenitor Cells Include In-Process Data on the Preparation of the Cells?

Abstract

There has been great interest in research and clinical trials with the adult stem/progenitor cells referred to as mesenchymal stem/stromal cells (MSCs). However, there are no definitive markers for the cells and no assays that would reflect the therapeutic efficacy of the cells in vivo. There are in effect no adequate release criteria that define the quality or efficacy of the cells. The problems are compounded by the fact that a variety of different protocols has been used to isolate the cells and expand them in culture. The result is that many publications have used MSCs with different properties, frequently without the investigators being aware of the differences. As a partial solution to these problems, we have devised a simple table to record in-process data on the preparation of MSCs.

Mesenchymal stem cells: mechanisms of potential therapeutic benefit in ARDS and sepsis

“…An emphasis on the need to ensure that preparations of MSCs used in clinical trials are of a standardised and verifi able quality is at the centre of many thoughtful reviews on the subject. 13,64,79,80,87,88 This requirement is challenging because many variables, such as temperature and culture density, can all aff ect MSC phenotype. 88 Furthermore, MSCs can be cultured from multiple sites, including adipose tissue, bone marrow, and muscle.…”

“…13,64,79,80,87,88 This requirement is challenging because many variables, such as temperature and culture density, can all aff ect MSC phenotype. 88 Furthermore, MSCs can be cultured from multiple sites, including adipose tissue, bone marrow, and muscle. Researchers do not yet understand how these cells diff er biologically nor are they able to reliably quantify how these MSCs diff er in their interactions with an injured host.…”

Potential advantages of acute kidney injury management by mesenchymal stem cells

“…This attempt to standardize the use of MSC in biomedical research is pivotal and should be extended to other sources of MSCs in order to promptly define functional and qualitative criteria for these cells. Indeed, the heterogeneity of protocols of isolation and expansion has the results that investigators have used MSCs with different properties without frequently being aware of these differences [19] . The use to record in process data during MSCs preparation and the availability of this information in the supplemental material could be useful to partially overcome the problem and optimize the comparison among different studies.…”

Research using Mesenchymal Stem/Stromal Cells: quality metric towards developing a reference material

“…The authors address all the current limitations in using MSCs in cell therapy context and propose a three step path forward to overcome this limbo; (a) uniformity in nomenclature (b) develop a reference cell type to be distributed from one center for MSC researchers heading towards pre-clinical or clinical path (c) A set of minimal information on the process of generating MSC. Prockop’s team further highlight the need for in process data to be included in all publications [4]. In this review, we further propose and not only support the need for generating such a reference standard MSC line (one cell type) but also creating a virtual database from different researchers using the reference MSC line for a prospective validation and better acceptable quality metric for MSCs.…”

“…Two recent papers authored by experts in the MSC field, highlight the need for a reference material [4, 5] to overcome some of these hurdles. The authors address all the current limitations in using MSCs in cell therapy context and propose a three step path forward to overcome this limbo; (a) uniformity in nomenclature (b) develop a reference cell type to be distributed from one center for MSC researchers heading towards pre-clinical or clinical path (c) A set of minimal information on the process of generating MSC.…”