Asymmetrex Report is the OBM Transplantation Special Issue Cover Story

by Asymmetrex

Asymmetrex recently wrote a report, A Computational Simulation Technology for Specific Counting of Perinatal and Postnatal Human Tissue Stem Cells for Transplantation Medicine, that was published as the cover story in OBM Transplantation Special Issue: Isolation and Characterization of Adult Therapeutic Cells. Read this detailed report to learn more about how the integration of principles of tissue stem cell asymmetric self-renewal  kinetics with computational simulation can achieve specific and accurate counting of therapeutic tissue stem cells.

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Asymmetrex Presents the Value of Tissue Stem Cell Counting For Supplying Stem Cell Clinical Trials and Drug Development Clinical Trials

by Asymmetrex

On September 30, stem cell biotechnology company Asymmetrex presented at the 2020 Outsourcing in Clinical Trials USA Virtual Conference. In addition to discussing the value of tissue stem cell counting for better practices in stem cell and gene therapy clinical trials, Asymmetrex director James Sherley also highlighted value that stem cell counting technologies can impart to traditional pharma and biopharma clinical trials.

Adapting to the present COVID crisis, this year the 2020 Outsourcing in Clinical Trials USA Conference, one of several international clinical trials supply trade conferences organized by Arena International Events Group each year, adopted a virtual meeting format. The conference, scheduled for September 30-October 1, continued its tradition of bringing together contract research organization suppliers and company sponsors in the clinical trials supply industry to discuss new developments and best practices.

Among the many industry members invited to speak in the event, James L. Sherley, M.D., Ph.D., founder and director of Massachusetts stem cell biotechnology company Asymmetrex, presented on September 30. Dr. Sherley’s presentation highlighted a growing new area of the clinical trials supply industry. More and more, the clinical trials supply industry is considering better technology and practices to support stem cell clinical trials and gene therapy clinical trials that utilize advanced therapy medicinal products. In particular, Dr. Sherley discussed the value of implementing new quantification technologies for ATMPs developed with tissue stem cells. He answered the rhetorical question that was the title of his talk – “How can we outsource stem cell clinical trials without counting tissue stem cells?” – by detailing places in ATMP supply chains where instituting counting technologies would provide significant benefits to the stem-gene clinical trials supply industry and the patients it serves.

Sherley also presented innovation proposals for traditional pharmaceutical and biopharmaceutical clinical trials supply. He described how tissue stem cell counting technologies represented advantages both for discovery of novel drugs and for toxicology evaluations of new drug candidates. A major value presented was the opportunity for drug companies to realize hundreds of millions of dollars in reduced costs each year by using tissue stem cell counting tests for earlier identification of drugs that would fail late in clinical trials because of inducing chronic failure of organs and tissues like the liver and bone marrow. Currently applied animal toxicology studies miss many drugs with this disastrous character. Sherley described how such drugs could be detected in inexpensive cell culture tests by counting how stem cell-specific number and viability changed in their presence.

Though not a main focus of the presentation, Sherley ended his presentation with acknowledgement of Asymmetrex’s recent introduction of the first-in-kind technology for counting therapeutic tissue stem cells and determining their dosage. The company holds issued patents for the technology and its use for drug evaluations in both the U.S. and U.K. In August of this year, it published a peer-reviewed report, co-authored with its partner AlphaSTAR Corporation, that describes the new method and its applications for stem cell therapy and drug evaluations. In September, the company was awarded a research and development grant from the National Institutes of Health-National Heart, Lung, and Blood Institute for continued development of the technology and its commercialization. These plans for the company’s AlphaSTEM Test™ tissue stem cell counting technology were recently reported.

About Asymmetrex

Asymmetrex, LLC is a Massachusetts life sciences company with a focus on developing technologies to advance stem cell medicine. The company’s U.S. and U.K. patent portfolio contains biotechnologies that solve the two main technical problems – production and quantification – that have stood in the way of effective use of human adult tissue stem cells for regenerative medicine and drug development. 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. Asymmetrex is a member company of the Advanced Regenerative Manufacturing Institute BioFabUSA and the Massachusetts Biotechnology Council.

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Asymmetrex Director Interviewed by Tech Company News About Recent Grant Award

by Asymmetrex

Asymmetrex recently received a $0.42 million award from the NIH-National, Heart, Lung, and Blood Institute to support technical development and commercialization of its first-in-kind technology for specific and accurate counting of therapeutic tissue stem cells. Tech Company News reached out to Asymmetrex Director James L. Sherley to interview him about this achievement and how the company plans to use the funds.

“In our recent published report, we established proof of concept with a few compounds. With the SBIR award, we will evaluate sufficient compounds to know quantitatively how well our test predicts not just tissue stem cell toxicity, but actual chronic organ failure in patients.”

Read the full interview here.

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Asymmetrex Receives $0.42 Million Award from the NIH-National Heart, Lung, and Blood Institute to Develop the AlphaSTEM Test™ for Stem Cell Therapies and Drug Evaluations

by Asymmetrex

On September 19, 2020, stem cell biotechnology company Asymmetrex was awarded a research and development grant from the NIH-NHLBI. The $0.42 million grant was awarded to support the company’s technical development and commercialization of its first-in-kind technology for specific and accurate counting of therapeutic tissue stem cells.

On the heals of Asymmetrex’s recently published peer-reviewed report describing its development of a method for quantifying therapeutic tissue stem cells, on Saturday September 19, the company received a Notice of Award of its first Phase I Small Business Innovation Research (SBIR) grant from the U.S. National Institutes of Health. Sponsored by the National Heart, Lung, and Blood Institute, the $0.42 million 1 year award recognizes the potential major impact of Asymmetrex’s first-in-kind technology in the stem cell medicine and drug development industries.

Asymmetrex founder and director James L. Sherley, M.D., Ph.D. spent most of Saturday contacting collaborators, contract service providers involved in the project, corporate partners, and industry colleagues who endorsed the grant application to share the news of the award. “I couldn’t wait until Monday to share this news. No one does biotechnology development and commercialization successfully alone; and Asymmetrex is fortunate to have the kind of support that gets a company to important milestones like this one.”

The new funds will accelerate the technical and business development of two applications of the company’s AlphaSTEM Test™ tissue stem cell counting technology. One goal is to evaluate in a head-to-head comparison how the company’s computational counting technology relates to the only existing method for specific estimation of the dosage of a therapeutic tissue stem cell.

Human blood stem cells can be estimated specifically by transplanting cells into mice. This test method is expensive, slow (taking 12-16 weeks), and variable. Asymmetrex already established – reported in the recent publication – that its technology compares well to the published literature for the mouse test, but has significantly less variability. The direct comparison will increase industry confidence and pave the way to raising more financing for advancing the AlphaSTEM Test™ to clinical evaluations. The company’s first clinical application target is determining the dose of stem cells in umbilical cord blood to identify which units will be lifesaving for children after leukemia treatment. In current clinical practice, 15-18% of children receive an ineffective transplant, because the stem cell dose was not known.

The second major milestone accomplished with award funding will be measurement of how well the AlphaSTEM Test™ identifies drug candidates that are toxic to tissue stem cells, like those in the liver and bone marrow. Drugs that are toxic to tissue stem cells cause chronic organ failure, a life-threatening event for clinical trial patients and a financial catastrophe for a drug development program. Such failures in Phase II and Phase III clinical trials cost the U.S. pharmaceutical industry $4-5 billion in losses each year. Currently, besides these late costly failures, the only way to identify tissue stem cell-toxic drug candidates is with expensive animal toxicology evaluations. Animal evaluations are notorious for their poor ability to predict human toxicities.

The company’s seminal report contains preliminary evidence of the AlphaSTEM Test™‘s ability to identify either tissue stem cell-toxic or tissue stem cell-activating compounds inexpensively in cell culture. The latter ability has application for discovery of new compounds that accelerate wound healing and combat effects of aging, including cosmetics. With the new award, Asymmetrex will extend the preliminary studies to the full-scale analyses needed by pharmaceutical companies for their evaluations.

About Asymmetrex

Asymmetrex, LLC is a Massachusetts life sciences company with a focus on developing technologies to advance stem cell medicine. The company’s U.S. and U.K. patent portfolio contains biotechnologies that solve the two main technical problems – production and quantification – that have stood in the way of effective use of human adult tissue stem cells for regenerative medicine and drug development. 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. Asymmetrex is a member company of the Advanced Regenerative Manufacturing Institute BioFabUSA and the Massachusetts Biotechnology Council.

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Asymmetrex Reports the First Quantitation of “True” Tissue Stem Cells In Stem Cell History

by Asymmetrex

In a recent report published in the journal OBM Transplantation, stem cell biotechnology company Asymmetrex reported the first counts of therapeutic “true” tissue stem cells in the history of stem cell science and medicine. This crucial research and clinical data, long-needed for accelerating the development of new and better stem cell medicines, is now readily obtained with the company’s innovative tissue stem cell counting algorithms.

“True” in stem cell science and stem cell medicine has a peculiar meaning. When applied to tissue stem cells, it reflects what has not been knowable instead of what is known. Since the earliest history of tissue stem cell science and medicine, no means existed to count tissue stem cells that maintain and regenerate the organs and tissues of children and adults. The need for an effective counting method has limited progress in stem cell research and medicine for decades.

The tissue stem cells that maintain organs and tissues are called “true” stem cells to distinguish them from other more numerous precursor cells in the body that also have important roles in building mature tissues and organs. However, other precursor cells – also known as committed progenitor cells – which are in fact produced by true stem cells, differ from true stem cells in a crucial respect. They have short lives before they turn into mature cells that eventually die. Only true stem cells have lifetimes for as long as the human lifespan. For the same reason, true stem cells are sometimes called “immortal” stem cells.

Because of the difference in lifetime, progenitor cells do not work for stem cell therapy and gene therapy. To be successful, stem cell therapies require true stem cells; and gene therapies must target true stem cells with their curative genetic engineering. Asymmetrex director, James L. Sherley, M.D., Ph.D., says, “So, it is no surprise that now being able to count and determine the dosage of true stem cells routinely, in all areas of stem cell science and medicine, has got to end up making a big difference for patients. With Asymmetrex’s advance, stem cell-blind research and stem cell-blind medicine are no longer acceptable practices.”

The company’s recent report, published in OBM Transplantation, describes the first-ever quantification of several different therapeutic tissue stem cell types. True blood stem cells obtained from both bone marrow and cord blood, which are approved for stem cell therapies, were counted for the first time. These stem cells are also in active use by many companies and centers to improve transplantation therapies and to develop gene therapies. Several different types of stem cells in use for clinical trial investigations were counted. The report also shows how the ability to count true stem cells is a new powerful tool for drug evaluations that can accelerate progress in the development of new pharmaceutical and biopharmaceutical medicines.

Beyond presenting the first technology for counting true stem cells, the new report describes Asymmetrex’s discovery of true stem cell counting algorithms. The newly discovered mathematical formulas allow rapid, inexpensive determination of stem cell number and dose. The new algorithms open the path to future automation of true stem cell counting. The new counting technology is free for evaluation on the company’s website.

About Asymmetrex

Asymmetrex, LLC is a Massachusetts life sciences company with a focus on developing technologies to advance stem cell medicine. The company’s U.S. and U.K. patent portfolio contains biotechnologies that solve the two main technical problems – production and quantification – that have stood in the way of effective use of human adult tissue stem cells for regenerative medicine and drug development. 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. Asymmetrex is a member company of the Advanced Regenerative Manufacturing Institute BioFabUSA (ARMI) and the Massachusetts Biotechnology Council (MassBio).

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New Report Begins a New Era of Stem Cell Science and Medicine: Stem Cell Biotechnology Company Asymmetrex Tells How It Counts Therapeutic Tissue Stem Cells

by Asymmetrex

In an August 28 special issue of the peer-reviewed online journal OBM Transplantation, stem cell biotechnology company Asymmetrex has now published a report describing how its technology for determining the specific dosage of therapeutic tissue stem cells works. The new technology is poised to revolutionize stem cell science and stem cell medicine by giving the long-needed means to quantity their essential focus, tissue stem cells.

Stem cell biotechnology company, Asymmetrex, has been counting tissue stem cells like those used for bone marrow and cord blood transplantation therapies for a few years now. Recently, the company announced the issue of patents for its first-in-kind technology both in the U.S. and the U.K. However, until last Friday, August 28, Asymmetrex had not reported in the peer-reviewed academic literature how it achieves this feat that had been pursued by many distinguished labs for more than six decades.

Now in a report published in a special issue of OBM Transplantation, a peer-review journal for transplantation medicine research, Asymmetrex completes its introduction of the new technology to the fields of stem cell science and stem cell medicine. The report is the second invited article published in a special issue focused on the “Isolation and Characterization of Adult Therapeutic Cells.”

The new report describes Asymmetrex’s discovery of mathematical formulas, call algorithms, that can be used to determine the number of stem cells in complex tissue cell preparations, like experimental samples or patient treatments. The stem cell counting algorithms are specific for different types of tissue stem cells. So, the algorithms defined for blood stem cells are distinct from the algorithms for liver stem cells, or lung stem cells. Once an algorithm is defined by the Asymmetrex technology, it can be used repeatedly as a simple, rapid, and inexpensive test to determine the quantity and dosage of its specific tissue stem cell type.

Asymmetrex’s founder and director, James L. Sherley, M.D., Ph.D., anticipated the August publication of the new algorithms in a talk given earlier at the 6th Annual Perinatal Stem Cell Society Congress in March of this year. Then and now, he says that he believes, “Now that the tissue stem cell counting algorithms are available, everything will change” in stem cell science and medicine.

Prior to Asymmetrex’s technology, there was no method for counting tissue stem cells in research, medicine, or for any other of their many uses. So, the impact of the stem cell counting algorithms in research and medicine is far-reaching. Such information is a game changer for accelerating progress in stem cell science and stem cell medicine, including improving treatments like gene therapy whose success depends on targeting tissue stem cells. There will also be tremendous gains in cell biomanufacturing, drug development, and environmental toxicology, all whose capabilities are currently limited by the lack of a facile means to quantify tissue stem cells.

To make the new counting technology readily accessible for evaluation by the greater academic, medical, and industrial stem cell communities, Asymmetrex provides free tissue stem cell counting on its company website.

About Asymmetrex

Asymmetrex, LLC is a Massachusetts life sciences company with a focus on developing technologies to advance stem cell medicine. The company’s U.S. and U.K. patent portfolio contains biotechnologies that solve the two main technical problems – production and quantification – that have stood in the way of effective use of human adult tissue stem cells for regenerative medicine and drug development. 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. Asymmetrex is a member company of the Advanced Regenerative Manufacturing Institute BioFabUSA and the Massachusetts Biotechnology Council.

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Asymmetrex’s Plan for Free Stem Cell Counting Is The Feature Story by Superb Crew News

by Asymmetrex

This week, Massachusetts stem cell biotechnology company Asymmetrex was the feature news story by online business and technology news platform Superb Crew. The attraction for the choice of Asymmetrex is the company’s recent announcement of its plan to begin offering free tissue stem cell counting to the stem cell research, stem cell medicine, and pharmaceutical industries.

In its June 22 online post, business and technology news platform Superb Crew reported its feature interview with Dr. James L. Sherley, M.D., Ph.D., founder and director of stem cell biotechnology company Asymmetrex. Superb Crew decided to highlight Asymmetrex after the company announced on June 16 that starting July 5 it would begin offering free tissue stem cell counting at its company website.

In the interview, Sherley discussed Asymmetrex’s tissue stem cell counting technology with the perspective that it is a very recent development for the industry. He noted that, like many new transformative biotechnologies, it and its value are not yet widely known. The planned free stem cell counting site is a part of Asymmetrex’s greater vision to increase academic and industry awareness of the need for tissue stem cell counting and its value, while at the same time making it readily available for immediate practice.

An earlier podcast series on “Counting Stem Cells” featured on the international stem cell industry networking platform RegMedNet, relates the many benefits of Asymmetrex’s technology for stem cell research, stem cell medicine, tissue stem cell biomanufacturing, pharmaceutical development, and environmental health science. By getting the technology out into use for free, Asymmetrex plans to “ignite a widespread adoption of tissue stem cell counting as [the] new normal” for tissue stem cell research, stem cell medicine, and drug development.

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 U.S. and U.K. 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 dosage and quality of tissue stem cell preparations (the “AlphaSTEM Test™”) for use in stem cell transplantation therapies, cell biomanufacturing, and pre-clinical drug evaluations. Asymmetrex is a member company of the Advanced Regenerative Manufacturing Institute BioFabUSA and the Massachusetts Biotechnology Council.

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Asymmetrex Announces Plans to Provide Free Tissue Stem Cell Counting

by Asymmetrex

Today, June 16, Massachusetts stem cell biotechnology company Asymmetrex announces that it will begin offering free tissue stem cell counting on its company website. Scheduled for opening July 5, Independence Day weekend in the U.S., the company’s counting site will give academic scientists, stem cell medicine physicians, tissue stem cell suppliers, and drug companies a new independence to begin incorporating exact numbers for tissue stem cell fraction and dosage in their research, stem cell treatments, cell manufacturing, and drug evaluations.

The director of stem cell biotechnology company Asymmetrex, Dr. James L. Sherley, M.D., Ph.D., is betting that if the stem cell medicine and pharmaceutical industries have easier access to stem cell counting, they will soon make it a routine part of their practice. So, starting July 5 of this year, Independence Day weekend in the U.S., Asymmetrex is offering free tissue stem cell counting at its website.

Obtaining a free stem cell count will only require entry of simple total cell count data at the company’s website. Counting total cells is a widely used, common practice throughout academic cell science, industrial cell manufacturing, drug development, and clinical medicine. However, counting tissue stem cells is only possible with Asymmetrex’s AlphaSTEM Test™ software technology. Simple cell culture procedures will be provided at the free stem cell count site. By following the simple cell culture and total cell counting procedures, any basic cell culture lab can generate the data needed for Asymmetrex to deliver a tissue stem cell-specific count to them in short order.

Asymmetrex’s tissue stem cell counting technology is a recent development for the industry. So, presently, its value is not widely known. There are many examples where the need for tissue stem cell counting has been ignored for years, because previously there was no way to do it. Counting would improve the design and interpretation of tissue stem cell research. Counting tissue stem cells would allow better optimization of cell and tissue manufacturing processes. Counting would provide better quality control for produced and transported tissue stem cell products. Counting would provide crucial dosages for stem cell treatments and stem cell clinical trials. Counting cord blood stem cells would make leukemia treatments for children more reliable. Counting tissue stem cells would provide inexpensive, early identification of stem cell-toxic drug candidates that would fail later in expensive clinical trials.

The planned free stem cell counting site is a part of Asymmetrex’s campaign to increase academic and industry awareness of the need for tissue stem cell counting and its value. In an earlier podcast series on “Counting Stem Cells” featured on the international stem cell industry networking platform RegMedNet, Director Sherley discusses the benefits of Asymmetrex’s technology for stem cell research, stem cell medicine, tissue stem cell biomanufacturing, pharmaceutical development, and environmental health science. Sherley now expects that, “The new free tissue stem cell counting site will give members of our industry the freedom to rediscover, for themselves, the value of counting.”

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 U.S. and U.K. 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 dosage and quality of tissue stem cell preparations (the “AlphaSTEM Test™”) for use in stem cell transplantation therapies, cell biomanufacturing, and pre-clinical drug evaluations. Asymmetrex is a member company of the Advanced Regenerative Manufacturing Institute BioFabUSA and the Massachusetts Biotechnology Council.

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