Asymmetrex Obtains UK Patent for Tissue Stem Cell-Specific Counting and Testing

by Asymmetrex

On October 2, 2019, the United Kingdom Intellectual Property Office issued a patent to Massachusetts stem cell biotechnology company Asymmetrex. The patent covers the company’s invention of the first and only technology for counting tissue stem cells specifically and identifying agents that affect tissue stem cells, positively or negatively. The new patent is another advance in Asymmetrex’s ongoing development of its AlphaSTEM Test™ technology as the solution to the longstanding unmet need for stem cell-specific counting in stem cell research, stem cell medicine, and drug development.

Today, Massachusetts stem cell biotechnology company Asymmetrex announces the recent patenting in the U.K. of its lead development technology. Like the company’s precursor patent, approved in the U.S. in 2017, the new patent covers the company’s unique technology for specific and accurate counting of tissue stem cells. Asymmetrex now markets the technology in the U.S. as the AlphaSTEM Test™. The new patent will support marketing and sales and investor development initiatives in the U.K.

Asymmetrex’s AlphaSTEM Test™ is the first and only technology to provide specific and accurate counting of tissue stem cells, both from mature adult tissues and perinatal tissues like the umbilical cord. By counting tissue stem cells specifically, the technology can determine the stem cell-specific dose of tissue stem cell treatments. The lack of this crucial information has limited progress in stem cell clinical trials that largely cannot be interpreted without it. Even currently approved stem cell treatments would benefit from stem cell-specific dose information. For example, in the case of bone marrow stem cell transplants, for which donors are scarce, knowing the stem cell-specific dose might allow additional patients to be treated with the same bone marrow donation.

Some areas of stem cell research and stem cell medicine have been slow to embrace the new technology. This is particularly true of companies that presently market isolated, manufactured, or cultured tissue stem cell-containing products, whether for research purposes or for patient treatments. Many have been unwilling to use the new technology to begin certifying the stem cell-specific count or dose of their products. Asymmetrex founder and director James L. Sherley, M.D., Ph.D., chides that this condition cannot persist. “It was one thing to be selling products with no stem cell number or dose, when it was not possible to determine the stem cell-specific count. But it’s a whole other thing, when it is now possible. Change is here.”

Specific stem cell counting is a less clouded issue for academic stem cell research labs. Basic research investigators would like to know how many stem cells are in their experiments. Accordingly, Asymmetrex is presently beta-testing the use of the technology in both U.S. and U.K. labs to position the technology to be more practical and affordable for stem cell investigators in colleges and universities.

There are two other broad categories of applications for the stem cell counting technology that often are not self-apparent. Gene therapy, including emerging gene editing, would benefit from tissue stem cell-specific counting. Because of their long-lived tissue renewing property, stem cells are the crucial targets for gene modifications to achieve single-dose, durable cures. Current clinical studies attempt gene therapy while blind to the number of stem cells during genetic modification procedures, as well as blind to the dose of genetically-modified stem cells in the final treatments.

Both Asymmetrex’s U.S. and U.K. patents cover the use of the stem cell counting technology to identify drug candidates that alter stem cells, whether with beneficial effects or detrimental effects. Drugs with beneficial effects may have efficacy for accelerating or improving tissue repair of wounds and injuries. Drug candidates with detrimental effects have even greater significance in drug development. Tissue stem cell-toxic agents cause chronic organ failures, like bone marrow or liver. This problem is estimated to be responsible for half of drug failures due to unacceptable toxicity, which are a major cause of unsuccessful drug programs. Previously, without a way to do inexpensive stem cell toxicity testing, U.S. pharmaceutical companies spent $4-5 billion each year watching these drugs fail in animal studies or subsequent clinical trials. By showing that its AlphaSTEM Test™ can identify drugs known to cause chronic organ failure, Asymmetrex is positioning itself to relieve the pharmaceutical industry of this huge cost burden with a simple, inexpensive cell culture test.

Later this month, Asymmetrex will begin a podcast series to expand and accelerate education of the inevitability of the change of stem cell research, stem cell medicine, stem cell manufacturing, and drug development to quantitative analyses for tissue stem cells. Earlier this year, the FDA Standards Coordinating Body (SCB) listed stem cell specific-dose determination as a priority for needed standards for regenerative medicine and stem cell therapies. Dose is a fundamental principle for the discovery, development, and administration of quality medicines. Sherley assures, “It can be no different for stem cell medicine. Our podcast will not just target the stem cell medicine and pharmaceutical industry. We also wish to inform the end users of stem cell products, patients, their families, and their advocates, including the FDA. When they understand and demand certification of the quality and dose of stem cells in their treatments, the industry will speed up its adoption of the change that must come.”

About Asymmetrex

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.

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Asymmetrex Leads OCTNE 2019 Discussion of the Growing Need for Tissue Stem Cell-Specific Dosing In Stem Cell Clinical Trials

by Asymmetrex

As the field of stem cell medicine begins to wake up to its critical need for tissue stem cell-specific dosing, biotechnology tools company Asymmetrex is leading the way. This week in Boston, at the 2019 Outsourcing in Clinical Trials New England conference, the company’s director gave a pointed presentation on how the current lack of stem cell-specific dosing is now unnecessarily undermining the quality of stem cell clinical trials as well as even approved stem cell treatments. Though not the focus of the presentation, Asymmetrex developed the first, and currently the only, technology for specific counting of therapeutic tissue stem cells.

Yesterday, at the 2019 meeting of Outsourcing in Clinical Trials New England in Boston, October 2-3, Asymmetrex founder and director, James L. Sherley, M.D., Ph.D., discussed important design factors that currently limit the success of early stage stem cell clinical trials. To an attendee audience including both developers and suppliers of clinical trials, in his talk, Dr. Sherley focused on the highly problematic practice of conducting stem cell clinical trials and stem cell treatments without knowing stem cell dose. He referred to the widespread lack of stem cell-specific dosing as “the major unacknowledged design feature that currently limits the success of ALL stem cell clinical trials.”

As for all effective medicines, stem cells are no different when it comes to the importance of knowing the dose. Sherley pointed out that, without knowing the dose of administered stem cells, it is impossible to interpret the outcome of current clinical trials. With an audience including manufacturers and suppliers of stem cell treatments for clinical trials, Sherley emphasized that the stem cell-specific counting problem extended to many aspects of producing and certifying the quality of tissue stem cell treatment preparations. In the case of manufacturing processes that aim to expand the number of tissue stem cells, some products may have diluted the stem cells to a negligible number and an ineffective dose.

Sherley also shared with attendees that change was now on the horizon of the regulatory landscape for stem cell-specific dosing. With the motivation of Asymmetrex’s new AlphaSTEM Test™ technology, which now makes specific and accurate counting of therapeutic tissue stem cells possible, earlier this year the FDA’s Standards Coordinating Body for Regenerative Medicine (SCB) listed stem cell-specific dose determination as a priority for the development needed standards to advance cellular therapies. Sherley notes, “This was a critical milestone for catching up stem cell medicine to being quantitative, like all the rest of medicine. If the FDA is going to regulate stem cells like other medicines, now that a counting technology is available, they should also guide this industry to its inevitable adoption of dose, a universally acknowledged, fundamental requirement for progress and success in medicine.

About Asymmetrex

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.

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Asymmetrex Approved to Conduct an ASTM Interlaboratory Evaluation of Its AlphaSTEM Test™ Technology as a Standard for Counting Therapeutic Adult Tissue Stem Cells

by Asymmetrex

On May 16, at the ASTM International May Committee Meeting in Denver, Colorado, Massachusetts stem cell biotechnology company Asymmetrex received unanimous approval of its proposal for an interlaboratory evaluation of the company’s AlphaSTEM Test™ technology for counting therapeutic adult tissue stem cells. Highlighting the importance of the approval, a day earlier, the Standards Coordinating Body released a new draft report that introduces tissue stem cell counting as a needed standard for improving progress in regenerative medicine clinical trials.

At their May 16 meeting, the members of the F04.43 Subcommittee on Cells and Tissue Engineered Constructs for Tissue Engineered Medical Products (TEMPs) of the American Society for Testing and Materials International voted unanimously to approve an interlaboratory study proposed by Asymmetrex. Gaining this approval was the next step in the company’s plan to establish its AlphaSTEM Test™ stem cell counting technology as a standard for stem cell medicine.

ASTM International is a 121 year-old organization that was founded and exists to improve and assure the quality of diverse industry manufactured products. It accomplishes this mission by developing worldwide consensus standards for industrial testing and industrial materials. Though founded on standards for factory operations and building materials, its purview now extends well beyond to standards for products like those covered by the F04.43 Subcommittee, including TEMPs and now therapeutic tissue stem cells.

The approval for Asymmetrex is very timely for the stem cell medicine industry. One day earlier on May 15, the Standards Coordinating Body released a working draft of its new report that identifies new standards needed for regenerative medicine. The SCB is an FDA-contracted agency with the mission of complementing the existing processes of standard development organizations like ASTM by engaging regenerative medicine stakeholders to ensure that new or revised standards provide the greatest benefits to the broad regenerative medicine community. One of the needed standards introduced in the draft report is a standard for specific counting of tissue stem cells investigated in stem cell therapy clinical trials.

Asymmetrex director James Sherley observes that, “the incorporation of standards need C20 on page 51 of the new report is an excellent example of evidence that the SCB is already achieving its mission of improving progress in regenerative medicine. Identifying and acknowledging fundamental knowledge and technological gaps will motivate ingenuity in scientific discovery and engineering.”

About Asymmetrex

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.

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Asymmetrex Presents Proposal for ASTM Interlaboratory Evaluation of AlphaSTEM Test™ Technology Towards Establishing A Standard for Counting Therapeutic Stem Cells

by Asymmetrex

Today, May 16, at the ASTM International May Committee Meeting in Denver, Colorado, Massachusetts stem cell biotechnology company Asymmetrex will present a proposal for an interlaboratory evaluation of the company’s AlphaSTEM Test™. Approval of this ASTM evaluation will be an important step in Asymmetrex’s plan to establish the AlphaSTEM Test™ as a stem cell industry standard for specific and accurate counting of therapeutic adult tissue stem cells.

In an FDA-contracted Standard Coordinating Body Workshop held at the National Institute of Standards and Technology in Rockville, Maryland, March 18-19 of this year, Asymmetrex founder and director James L. Sherley, M.D., Ph.D. predicted a sea change in thinking on the feasibility of standards for counting therapeutic adult tissue stem cells. Many of the gathered participants dismissed this idea. Few argued against the importance of having a standard for quantifying the number of stem cells in stem cell treatments, stem cell manufacturing, and drug development. However, many were of the view that establishing a standard was out of the question because adult tissue stem cell science was not sufficiently mature to support a method for counting its essential principals.

Sherley, one of a few adult tissue stem cell experts in the workshop, argued passionately to the contrary, based on the merits of his company’s AlphaSTEM Test™, the first reported technology for achieving specific and accurate counting of therapeutic adult tissue stem cells in complex tissue cell preparations. Asymmetrex’s participation in the March SCB Workshop led to an invitation from ASTM International staff for the company to present a proposal for an interlaboratory evaluation of its new test at a future ASTM Committee meeting.

The American Society for Testing and Materials International is a 121-year-old organization that was founded and exists to improve and assure the quality of a vast landscape of industrial manufactured products. ASTM accomplishes this service to humanity by developing worldwide consensus standards for industrial testing and industrial materials. Though founded on standards for factory operations and building materials, its purview now extends well beyond to medical procedures and human tissue cell quality.

Interlaboratory evaluations are an important step on the path to standard certification by ASTM. Asymmetrex gave an initial presentation of its tissue stem cell counting standard concept at an ASTM International Committee Meeting in Washington, D.C. in November 2018. An interlaboratory evaluation was recommended at that time. In today’s proposal presentation, the company will present test property data from its three current cell culture contractor sites, Toxikon Corporation in Massachusetts, Drik in Oklahoma, and the MTECH-BAF in Maryland. The contractor data establish the general high quality of the AlphaSTEM Test™ for determinations of several different therapeutic human adult tissue stem cell types. The proposed interlaboratory study will go further to evaluate similar test properties across five to ten different academic and industrial labs all testing the same source of human tissue stem cells.

Based on the excellent intrinsic test properties observed for Asymmetrex’s individual contractors, Sherley is optimistic that the interlaboratory study will be similarly supportive for moving on to the final stages of ASTM standard certification. “We want for stem cell medicine what ASTM wants for all industries that serve humanity: ‘Helping our world work better.’ Establishing a standard for counting therapeutic adult tissue stem cells will help stem cell medicine work better.”

About Asymmetrex

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.

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Asymmetrex Visits World Drug Safety Congress 2019

by Asymmetrex

Tuesday in Philadelphia, at the World Drug Safety Congress 2019 (April 16-17), Asymmetrex introduces its AlphaSTEM Test™ to the international pharmaceutical community.  By early detection of drug candidates that are stem cell-toxic, Asymmetrex can eliminate drugs that will fail late after great cost because they induce chronic organ failure.  By assaying for toxic effects on organ and tissue stem cells specifically, very bad drugs can be identified sooner, without injuring patients, and at greatly reduced development cost.  Spend 2 minutes learning more about the technology that Asymmetrex is introducing.  #WeCountStemCells…Specifically!

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Asymmetrex Article on p53 and CRISPR/Cas9 is Among CRISPR Journal’s ‘Articles Everyone is Talking About’

by Asymmetrex

This week The CRISPR Journal released the articles that people are talking about, and Asymmetrex’s article on p53 and CRISPR/Cas9 made the list. This article is free to read until February 7, 2019.

“I wish to suggest another explanation for the worrisome observations based on often overlooked properties of p53 as a regulator of postnatal tissue stem-cell kinetics. Unlike the DNA damage explanation, the second interpretation of the two reports also provides a simple solution for testing and application.”

Read the full article while it is available here.

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Asymmetrex Writes Article for Parent’s Guide to Cord Blood

by Asymmetrex

Now in its fifth month, Massachusetts stem cell biotechnology company Asymmetrex continues its campaign to increase awareness of the adult tissue stem cell counting problem in stem cell medicine. Now targeting patients and patient advocacy groups, for the month of January, the company’s director is featured on the Parents’ Guide to Cord Blood website with a news article that describes the company’s new solution for this long-standing challenge in stem cell transplant medicine.

On January 15 of this year, the Parents’ Guide to Cord Blood website featured an invited news article by Asymmetrex Director James L. Sherley, M.D., Ph.D. The PGCB was founded by former physicist Dr. Frances Verter, who now runs cell therapy resources like the PGCB and CellTrials.org. Now in its 21st year of operation, the PGCB continues its mission to educate parents with accurate and balanced information about cord blood banking, medical therapies, and cord blood storage options.

In his news article, Sherley takes the opportunity to share with parents, who store cord blood from their babies for future use in medical treatments, information about the newest advance in stem cell medicine. This advance made by Asymmetrex and its partner company, AlphaSTAR Corporation, is quite relevant to cord blood storage and use for medical treatments.

Working together the two companies devised a computer simulation approach to solve the stem cell counting problem. The new technology could be used to determine the dose of therapeutic stem cells in stored cord blood samples for the first time. Such knowledge would address presently intractable problems in cord blood transplant medicine, like identifying the high fraction of stem cell-deficient cord blood samples before they fail a patient.

The PGCB education opportunity fits well within Asymmetrex’s ongoing campaign to increase awareness to the half-century-old stem cell counting problem. Asymmetrex’s new advance, introduced into the stem cell medicine industry two years ago, is the first, and still the only, solution for the stem cell counting problem.

Since the introduction of Asymmetrex’s AlphaSTEM Test™ for specific and accurate counting of therapeutic tissue stem cells, the company’s market research made it quite clear that the stem cell counting problem was quite insidious, with many in the industry being unaware or uncertain of it and the medical deficiencies it causes. Asymmetrex’s response has been to increase awareness to the problem, including among patients; and in the case of kids, their parents.

Frances Verter’s invitation supports Asymmetrex’s education effort. “Arguably the most important question in stem cell medicine is how to accurately measure the doses of therapies, and now Asymmetrex proposes a solution.” The news article is an important effort towards bringing this crucial information to the full awareness of patients, as they can be quite effective in bringing its importance to the attention of stem cell doctors.

Of course, parents are not the only subscribers to the PGCB. A wide and diverse range of the participants in stem cell medicine and the stem cell supply industry also utilize the website. Sherley observes that, “The more who know, the more and sooner our solution will be evaluated for being the new quantitative standard for therapeutic stem cells in stem cell biology and medicine. That’s our goal.”

About Asymmetrex

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.

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Asymmetrex Publishes Chapter Explaining the Critical Need for Stem Cell Dosing

by Asymmetrex

Since September 2018, Massachusetts stem cell biotechnology company Asymmetrex has been pursuing a campaign to increase awareness of the adult tissue stem cell counting problem in stem cell medicine and the stem cell supply industry. The latest 2018 installment in this effort is a book chapter, authored by Asymmetrex’s founder and director, that illuminates why a means to count the number of stem cells in stem cell treatments is crucial for progress in stem cell medicine.

When Dr. James L. Sherley, M.D., Ph.D., founder and director of Massachusetts stem cell biotechnology company Asymmetrex, was invited to contribute a chapter to the new book Perinatal Stem Cells: Research and Therapy, he knew immediately what his topic would be. “I wanted to continue Asymmetrex’s effort to address a debilitating secret of stem cell medicine. For more than a half-century, stem cell medicine has tried to advance without knowing the dose of stem cells in stem cell treatments.”

Although it is inconceivable that patients in any other medical setting would be administered drugs or medicines without knowing their dose – number of drug molecules, weight of medicines – this otherwise unacceptable practice is usual for stem cell treatments. Whether they are approved treatments like bone marrow and cord blood transplants, or new treatments evaluated in clinical trials, or controversial treatments offered in private stem cell clinics, in all cases, the dose of stem cells administered to patients is unknown.

The tissue stem cell dose problem is not limited to clinical applications either. Upstream of medical and clinical uses, stem cell preparations are also supplied without knowing the number of stem cells contained in them.

In the recently published book chapter, “Dose Determination for Stem Cell Medicine: A Need Whose Time Has Come,” Sherley discusses why this situation exists and persists. He describes “pseudo-dosing” as the practical response by the field of stem cell medicine and the stem cell supply industry to the previously unsolvable problem of counting therapeutic tissue stem cells specifically and accurately.

Pseudo-dosing comes in many forms, but the most common is due to tests that do not count tissue stem cells specifically. Existing widely-used, but misnamed, “stem cell biomarkers,” “stem cell assays”, and even “stem cell counts” have contributed to the surprisingly commonly-held misconception that therapeutic stem cell counting and dose determination occurs routinely as for other medical treatments. Sherley’s chapter emphasizes that nothing could be farther from the truth, and goes on to outline the tremendous losses in treatment quality and stem cell medical progress caused by this remarkable misunderstanding.

Education to correct the misconception that stem cell counting and stem cell dosing have been in place all along can improve progress in stem cell medicine. However, Sherley points out that education about emerging new technologies for specific counting of tissue stem cells would have an even greater impact. The chapter also describes novel strategies for discovery of specific stem cell biomarkers and Asymmetrex’s recent development of a computational method for counting adult tissue stem cells for the first time. Director Sherley and his AlphaSTEM Test™ team anticipate that instilling a better understanding of the long-standing stem cell counting and dosing problem will motivate more rapid evaluation and adoption of the long-needed, if not necessarily long-awaited, solution.

About Asymmetrex

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.

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Asymmetrex Intensifies Campaign to Increase Awareness of the Adult Tissue Stem Cell Counting Problem

by Asymmetrex

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.

About Asymmetrex

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.

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