Since September of this year, stem cell biotechnology company Asymmetrex has been leading a campaign to increase awareness of the adult tissue stem cell counting problem in stem cell medicine and the stem cell supply industry. During the month of November, the company is intensifying this effort with new educational publications and presentations at clinical trial supply conferences, at meetings of standards development agencies, and at university laboratories.
“The greatest barrier to progress in stem cell medicine is not the lack of a means to count adult tissue stem cells,” corrects James L. Sherley, M.D., Ph.D., founder and director of Asymmetrex. “Instead, the more debilitating barrier is the presently poor awareness that the problem exists. Even experts in many disciplines of stem cell research and stem cell medicines think we can, or act as if we can, count therapeutic tissue stem cells. But in reality, no previously used method can count tissue stem cells accurately.”
During the month of November, Sherley is undertaking several endeavors to increase awareness of the tissue stem cell counting problem, which he defines as a problem that Asymmetrex has now solved with its recently introduced AlphaSTEM Test™ service, which provides specific and accurate counting of stem cells from any perinatal or postnatal organs and tissues. At November events, Sherley intends to continue focusing on increasing awareness and understanding of the long-standing unmet need for a means to count tissue stem cells.
On November 6, Sherley delivered a lecture at the 2018 10th Annual Outsourcing Clinical Trials New England Conference in Boston to relate how the need for stem cell counting impacts the regulatory landscape for supplying tissue stem cells to clinical trials. On November 8, he will introduce the AlphaSTEM Test™ to attendees at the American Society for Testing and Materials International 2018 Committee Week in Washington, DC to begin a discussion of developing standards for tissue stem cell counting and dose determination. Later in Boston, on November 14-15 at the 2018 3rd Annual Preclinical Development Operations Summit, he will discuss the need for development and adoption of an industry-wide regulatory standard for tissue stem cell counting, dose determination, and stem cell supply quality control.
To further illuminate the challenges of the poor level of awareness of the tissue stem cell counting problem, in an invited essay published November 6 on the Arena International Clinical Trials Supply website, Sherley compares the present state of the industry’s treatment of the issue to the Hans Christian Andersen fairy tale the Emperor’s New Clothes. He argues that, for the stem cell industry, the debilitating consequences of this situation are more than just a fairy tale.
In the Andersen story, swindlers convince a town’s emperor that they can weave fabrics so finely that they will be invisible to anyone who is stupid or unfit for their position. The emperor empties out the town treasury to pay to have clothes made from these remarkable linens. Of course, the swindlers weave only air and outfit the emperor with nothing at all, leaving him to walk about in only his undergarments. Fearing possible discovery as being stupid and unfit, the emperor’s most trusted advisors, also seeing nothing, join the emperor’s feigned amazement and praise garments that are not there. When a young boy speaks honestly about seeing the emperor parading down the street in his underwear, the townspeople acknowledge the deception; but the emperor and his elite courtiers persist in their pretense to avoid further embarrassment.
Sherley writes, “In the [stem cell industry], quantification of adult tissue stem cells has been the emperor’s new clothes for many years.” Though many in the industry are misinformed about, or unaware of the need for stem cell counting, there are many industry leaders who perpetuate the myth that it is possible to count tissue stem cells either knowingly or unwittingly. Sherley points out that an internet search will identify many examples of claims of tissue stem cell counting, tissue stem cell assays, tissue stem cell dose, and tissue stem cell reagents that the authors could not possibly know to be true, because they have not counted tissue stem cells specifically…yet. This is the limiting state of affairs that Asymmetrex is working to change with its first-in-kind technology for counting adult tissue stem cells.
Asymmetrex, LLC is a Massachusetts life sciences company with a focus on developing technologies to advance stem cell medicine. Asymmetrex’s founder and director, James L. Sherley, M.D., Ph.D. is an internationally recognized expert on the unique properties of adult tissue stem cells. The company’s patent portfolio contains biotechnologies that solve the two main technical problems – production and quantification – that have stood in the way of successful commercialization of human adult tissue stem cells for regenerative medicine and drug development. In addition, the portfolio includes novel technologies for isolating cancer stem cells and producing induced pluripotent stem cells for disease research purposes. Asymmetrex markets the first technology for determination of the dose and quality of tissue stem cell preparations (the “AlphaSTEM Test™”) for use in stem cell transplantation therapies and pre-clinical drug evaluations.