April 30, 2014

Is It Impolite to Ask an MSC Its Real Age?

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 standardization of materials, equipment and processes is critical to driving reproducibility and robustness of living cell technologies.   As we continue to engage researchers in Industry and Academia in high-level scientific discussions, it has become apparent that we, as a community, need to adopt more standardized means of accounting for our cell culture practices and what that really means in terms of Mesenchymal Stem Cell (MSC) age and function.

Given MSCs definition as the plastic-adherent fraction of the bone marrow, and their need to be expanded ex vivo prior to therapeutic administration, age has often been associated with and reported as a function of passage level, or the number of times these cells have been plated onto and harvested from tissue culture plastic.  True MSC age, however, is actually related to when these cells will senesce (i.e. stop growing), and this is a function of how many times the cells have divided, or their population doubling level (PDL).

April 9, 2014

Regenerative Medicine Standards Development – an FDA Workshop and an Initiative in Need of Structure

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 of particular task, be it for personal or professional applications.  Since standards are so important to RoosterBio’s long-term mission of Democratizing Cellular Technologies, I devoted my March 31st to attending an FDA-hosted public workshop titled Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine.  The agenda for the day can be found here.

There has been a robust ongoing effort forged between several academic and industry groups (ISCT, ARM, TERMIS) and standards-related organizations (NIST, ASTM, ISO, AABB, ICCBBA, USP, FACT) to establish standards for cell therapy and regenerative medicine; enough that the FDA thought it wise to begin to try to organize and coordinate these activities.  Thus, the purpose of this workshop was to “bring together a broad range of stakeholders to discuss current and future standards development activities involving cellular therapies and regenerative medicine products”.  While there wasn’t a lot of “action” at this meeting, it was a very good mechanism for understanding the landscape of the various activities, who some of the key players are, and how to get actively involved in the dialogue.