Human mesenchymal stem cells (hMSC) are currently in use in over 400 clinical trials and are critical components of tomorrow’s cell-based products and devices (1, 2, 3). Secretion of biomolecules by hMSC influences many biological processes and is thought to be central to the mechanism of action. Since widespread clinical use of hMSC and cell-based therapies with positive economic outcomes will be facilitated by frozen storage, cryopreserved hMSC must maintain high levels of biological function upon thaw. Additionally, while hMSC have an excellent clinical track record in terms of safety, efficacy data has been difficult to come by, suggesting that more standardized cell formats are needed. This too could be addressed by effective means of cryopreservation, allowing off-the-shelf hMSC products to be widely used in Regenerative Medicine, Tissue Engineering and for 3D BioPrinting of cells and tissues. Read More
We are always looking for ways to enable the commercialization of Cell-based Therapies and Technologies. The ultimate success of the field is dependent on the convergence of several technology fields, and one that isn't given sufficient attention is the Measurement Sciences (or metrology). The National Institute of Standards and Technology (NIST) has a Biosystems and Biomaterials Divisionthat... Read More
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<div class="MsoListParagraphCxSpFirst" style="margin-left: 0in; mso-add-space: auto;"><span style="font-family: 'Arial',sans-serif;">We blogged recently about </span><a href="http://roosterbio.blogspot.com/2014/10/current-bottlenecks-in-msc-research.html"><span style="font-family: 'Arial',sans-serif;">Mesenchymal Stem/Stromal Cell (MSC) Misconceptions</span></a><span style="font-family: 'Arial',sans-serif;"> that are holding the translational cell therapy field back, as identified by </span><a href="http://www.scripps.edu/florida/philanthropy/action/phinney-profile.html"><span style="font-family: 'Arial',sans-serif;">Donald Phinney</span></a><span style="font-family: 'Arial',sans-serif;"> and </span><a href="http://www.stromalab.fr/index.php?option=com_content&amp;view=article&amp;id=86&amp;lang=en"><span style="font-family: 'Arial',sans-serif;">Luc Sensebé</span></a><span style="font-family: 'Arial',sans-serif;">. Since we have come to market with our own hMSC product lines, we have spoken with hundreds of MSC researchers and engineers, and we have compiled our own...</span></div> Read More

We blogged several months ago about bottlenecks in the bioprocessing of Mesenchymal Stem Cellsthat are impeding their clinical translation. While the development of robust and scalable manufacturing methods, reduced cost of goods, and implementation of solid Quality Systems are all necessary for increased clinical use of MSCs, there are also current misconceptions surrounding MSCs, rooted in...
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Human MSCs are the single most used cell source for tissue engineering and regenerative medicine applications, and clinical trials involving hMSCs have outpaced all other cell types in recent years (see hereand here). However, despite indications of clinical effectiveness (see here and here), there is repeated news of the failure of high-profile MSC trials to demonstrate efficacy in a number of...
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There has been much discussion in the literature and the blogosphere (here, here, and here) lately about keeping track of cellular age, and there is very good reason for this. First, there are multiple regulatory guidelines that propose tracking the age of cells used in biologics manufacturing. Secondly, it is well documented that cell phenotype and function can be compromised the older a cell is.... Read More
MSCs truly are the Workhorse of Regenerative Medicine, and their use in Orthopaedic applications is where clinical translation was initially imagined. However, the robust signaling activityof MSCs has widened the range of clinical indications to include cardiac, vascular, and neurological regeneration, as well as immunological applications (eg. GVHD, Chron’s disease), and more recently, cancer...
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Extreme cellular stress can trigger senescence, a mechanism protecting
against malignant cell transformation.
Adapted from:
Kovacic J C et al. Circulation. 2011;123:1650-1660
We’ve mentioned several times on this blog how standardizationof materials, equipment and processes is critical to driving reproducibility and robustness of living cell technologies. As we continue to engage researchers in...
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As we stated in an earlier blog post, standardization of materials, equipment and processes will be critical to drive reproducibility and robustness of living cell technologies to the point where they can be widely used and considered “Democratized”. Some day in the future, an advanced degree and several years of training will not be a pre-requisite for a person to use living cells for some type...
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