Asymmetrex Co-Sponsors Expert Panel Discussion on Stem Cell Characterization with RegMedNet

by Asymmetrex on November 15, 2017

An international audience of regenerative medicine interests has registered to attend a November 30 online expert panel discussion on the current nature and quality of therapeutic tissue stem cell preparations. Co-sponsored by U.S. stem cell biotechnology company Asymmetrex and U.K. headquartered regenerative medicine social media network RegMedNet, the panel will dispel common misconceptions about the nature of tissue stem cell therapy products and review emerging technologies developed to improve their quality.

On November 30, Asymmetrex and RegMedNet will co-sponsor an online panel discussion on “Stem Cell Characterization.” Expert panelists include James L. Sherley, Director of Asymmetrex, Rouzbeh Taghizadeh, Chief Scientific Officer of AuxoCell, and Glyn Stacey, Executive Director of the International Stem Cell Banking Initiative. The panelists will discuss current challenges to producing and characterizing therapeutic stem cell preparations. They will consider stem cell populations commonly used for therapy, both after direct isolation and after manufacturing processes performed to increase the number of stem cells available.

A major goal of the panel is to unveil and correct several widespread misconceptions and mis-approximations that exist in the field of regenerative medicine regarding the nature and quality of current stem cell preparations either used for treatments or evaluated for cell therapy development. Respectively, these erroneous ideas and the misguided practices that follow from them impede progress in the development of effective stem cell therapies.

Donor stem cell preparations are often used as if they were homogenous stem cells. When, in fact, isolated treatment preparations are highly heterogeneous for tissue cell type, and stem cells are a minute fraction of the total cells in samples. A second misconception emerges from attempts to expand tissue stem cells in manufacturing processes. Instead of increasing the number of stem cells, these procedures lead to further decreases in the stem cell fraction; and sometimes to the point that no stem cells are present at all. Ironically, although such declines in stem cell activity are a widely recognized production problem, there are few producers who understand that it is the biological consequence of the unique tissue renewal properties of tissue stem cells.

The mistaken thinking, which keeps these first two misconceptions going, is the confused belief that available “stem cell biomarkers” detect tissue stem cells specifically. In fact, these biomarkers detect both stem cells and committed progenitor cells, the latter which do not have the curative properties of stem cells. So, biomarkers that are widely used cannot count tissue stem cells. Given the first two misconceptions in stem cell characterization, it is understandable why this third misconception has greatly confounded progress in stem cell science and stem cell medicine. Without a means to count tissue stem cells specifically, it is impossible to monitor, and thereby optimize, their production or know their treatment dose.

The panelists will also discuss potential solutions to the technical problems that underpin the misconceptions about the characterization of therapeutic tissue stem cells. Quantification, standardization, reproducibility, and automation will be discussed as core principles to improve both the quality of therapeutic tissue stem cells and their characterization. Emerging technologies like Asymmetrex’s AlphaSTEM Test™ for specific counting of adult tissue stem cells, which have potential to become needed solutions, will be reviewed as well.

In his promotion of the event, Asymmetrex Director Sherley assures that, “For anyone interested in producing higher quality tissue stem cells, or obtaining higher quality tissue stem cells, this is the event to attend.” He adds, “I hope the executives at the FDA Center for Biologics Evaluation and Research also attend.” To increase Aymmetrex’s impact in accelerating progress in stem cell regenerative medicine, the company has set a goal of gaining inclusion of its first-ever technology for quantifying therapeutic stem cell dose in currently anticipated, or future, FDA policies for improving the quality of stem cell treatments in medical centers with approved therapies, FDA-authorized clinical trials, and private stem cell clinics.

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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AsymmetrexAsymmetrex Co-Sponsors Expert Panel Discussion on Stem Cell Characterization with RegMedNet

Produce Greater Numbers of Therapeutic Adult Tissue Stem Cells at Reduced Cost

by Asymmetrex on August 29, 2017

For many years, progress in stem cell medicine has been held back because of a lack of effective and efficient methods for the manufacture of therapeutic adult tissue stem cells. Massachusetts stem cell biotechnology company Asymmetrex announces this week that it now offers a new contract service that can help suppliers of therapeutic adult tissue stem cells produce significantly more stem cells at greatly reduced cost.

Asymmetrex Introduces New Contract Service to Produce Greater Numbers of Therapeutic Adult Tissue Stem Cells at Reduced Cost

Today, Asymmetrex, the Massachusetts based stem cell biotechnology innovator, begins offering a new contract service to support the cell therapy industry’s production of therapeutic adult tissue stem cells. Stem cells are a small sub-population of specialized cells that function to renew and repair the organs and tissues of children and adults. Stem cells from a healthy donor can be transplanted to restore or repair diseased or damaged organs and tissues in patients who are sick or injured.

Stem cell transplant treatments do not require expansion of donor stem cells when a donor with a compatible immune system is available for a patient. However, in general, there are many more patients in need of a transplant than there are immune compatible donors. So, the future ability of stem cell medicine to address the full degree of medical need depends on developing the ability to expand initial donor stem cell populations into larger numbers without loss of their curative properties. Expanded numbers of quality adult tissue stem cells are also needed to support statistically sound clinical trials for continued development of stem cell transplant therapies.

Asymmetrex’s new advance for cell therapy suppliers is the result of the company’s unique proprietary expertise in adult tissue stem cell culture. Its recently patented AlphaSTEM Test™ technology, which is a means to count adult tissues stem cells specifically for the first time, is based on the earlier discovery that during expansion in culture, ironically, adult tissue stem cells are lost as a result of their intrinsic tissue renewal property. Under typical culture conditions, stem cells continuously produce non-stem cells that subsequently undergo significant, though limited, multiplication. However, as in the body, stem cells do this while not multiplying their own number. The result of these continued natural processes in culture is progressive dilution and loss of the stem cells with each subsequent expansion culture.

Recently, Asymmetrex demonstrated that not only can its AlphaSTEM Test™ technology be used to count and certify the quality of adult tissue stem cells, but it can also be used to establish unique culture conditions projected to reduce stem cell dilution significantly during expansion. Asymmetrex’s Director, James L. Sherley, M.D., Ph.D., shares, “Two years ago when we achieved specific counting, I expected that we would be able to find conditions for increasing stem cell number, too; but even I didn’t anticipate the projected huge savings in production costs!” The company’s projections indicate that it can achieve production of twice as many stem cells as several companies have reported, but require only 5% or less of their production cost. The required culture time is also reduced significantly.

The new service has been developed first for human mesenchymal stem cells, which are found in a variety of tissues including bone marrow, adipose (fat), umbilical cord, and amniotic fluid. These cells are an ideal first focus, as there are many companies worldwide working on their production to supply hundreds of stem cell transplantation clinical trials each year. Asymmetrex plans to also investigate application of the method to other types of adult tissue stem cells, which have been largely dismissed for expansion because their donor populations are not as proliferative as mesenchymal stem cells. Sherley says that blood stem cells are a very important member of this latter group on the Asymmetrex horizon.

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 – quantification and production – 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 in pre-clinical assays for drug safety. The same technology underpins Asymmetrex’s contract service for optimizing manufacturing processes for therapeutic adult tissue stem cells.

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AsymmetrexProduce Greater Numbers of Therapeutic Adult Tissue Stem Cells at Reduced Cost

Asymmetrex Issues New Stem Cell Patent

by Asymmetrex on August 15, 2017

Since the beginnings for stem cell research and stem cell medicine, it has not been possible to count tissue stem cells, determine their therapeutic dose, certify their quality, or evaluate the effects of drugs and environmental agents on their function. But, today the US Patent & Trademark Office signals the end of this situation by its scheduled issue, to Massachusetts biotechnology start-up company Asymmetrex, the first patent for specific quantification of adult tissue stem cells and certification of agents that affect their function.

Asymmetrex Issues New Stem Cell Patent for Counting and Evaluating Therapeutic Adult Tissue Stem Cells; Supports Company’s New Stem Cell Production Services

Any expert in stem cell research or stem cell medicine knows well the major unmet need that has compromised these disciplines for more than half a century. Despite their essential roles in human health and regenerative medicine, adult tissue stem cells cannot be counted. It is widely known that molecular tags developed for this purpose also tag other, more abundant, non-stem tissue cells (See 2017 Cell & Gene Exchange video). But many non-experts are surprised when they learn that stem cell science and stem cell medicine are held back because of not knowing the number of stem cells in experiments or the dose and quality of therapeutic tissue stem cells in treatments. And the lack of a way to quantify tissue stem cells means that detection of drug candidates or environmental agents that impact them is prohibitively complex and expensive.

The new patent is the basis for Asymmetrex’s contract research service, the AlphaSTEM Test Service. In addition to the company’s website, the contract service is listed on Science Exchange and The Scientist’s Suppliers sites as a certified provider and featured supplier, respectively. The new technology uses simple total cell count data from serially passaged cell cultures to decipher, for the first time, the specific number and functions of tissue stem cells in complex preparations like experimental or treatment samples. The desired data is extracted with proprietary computer simulation software developed with partner AlphaSTAR Corporation.

Asymmetrex offers its new contract service to diverse users in tissue stem cell research and medicine. Several national and international academic labs are now beta-testing the counting technology for quantifying stem cells in tissues of different animal species. Centers and clinics providing either approved or experimental therapies can use the service to determine the dose and quality of stem cells in their treatments. Asymmetrex estimates that many U.S. pharmaceutical companies would save hundreds of millions of dollars in unnecessary animal studies and clinical trials, if they employed the AlphaSTEM Test service for early screening for stem cell-toxic drug candidates. In later more expensive evaluations, these are the common drug candidates that cause chronic organ failure. In much the same way that the service can identify stem cell-toxic agents, it can also identify beneficial compounds that promote stem cell health or production.

A more recent projection of the technology’s application indicates another exciting prospect for accelerating progress in stem cell therapies. Production of tissue stem cells of sufficient number and quality to support stem cell transplantation treatments is another well-known major technical challenge in stem cell medicine. Not only can the AlphaSTEM technology provide monitoring of stem cell number during production processes, but it can also be used to design more efficient and effective production. For bone marrow-derived mesenchymal stem cells, company founder and director James Sherley, M.D., Ph.D. states, “We can provide stem cell producer companies simple methods for producing twice as many stem cells, in half the time, at 5% or less the cost.” So, both cell therapy developers and their stem cell suppliers should take great interest in the new services and their advantages.

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 quality and dose of tissue stem cell preparations (the “AlphaSTEM Test”) for use in stem cell transplantation therapies and in pre-clinical assays for drug safety.

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AsymmetrexAsymmetrex Issues New Stem Cell Patent

Asymmetrex Joins RegMedNet Panel to Discuss Cell Therapy Regulation

by Asymmetrex on June 22, 2017

In an online forum scheduled for June 27, 2017, the regenerative medicine social media network RegMedNet will sponsor a panel discussion on emerging developments in the global landscape of government regulations for stem cell medical research. Asymmetrex, a company developing new methods for specifically quantifying adult tissue stem cells, will provide expertise on the panel for the impact of a new emerging technology for determining the quality and dose of adult tissue stem cell treatments.

Asymmetrex Joins RegMedNet Panel to Discuss Cell Therapy Regulation

For the months of May and June, United Kingdom-based social media network RegMedNet has produced a Spotlight series on “Cell Therapy Regulation” for its regenerative medicine followship. The series has featured scholarly reviews and perspectives by leading experts on the unique regulatory challenges of stem cell medical research.

Stem cell clinical trials present unique regulatory challenges that are not an issue in conventional pharmaceutical and biopharmaceutical clinical research. On the one hand, introducing patients’ own cells, and even cells from matched donors, so far has been observed to be a relatively safe medical procedure. However, the small numbers of patients enrolled in clinical trials thus far have precluded evaluations of the reproducibility of efficacious effects associated with some transplanted cells.

The Spotlight takes a global look at current and changing regulatory policy for stem cell medical research. Experts review and evaluate recent policy developments for government agencies in the U.S., Europe, Japan, Canada and other countries.

On June 27, the Spotlight series will feature an online panel discussion of the topic. Panelists include leaders in companies and agencies that support development of cell therapeutics. James L. Sherley, M.D., Ph.D., Director of Asymmetrex, is one of the invited panelists. Sherley adds a perspective that has been missing from recent panels of this type on many different aspects of cell therapy, in particular, cell therapy regulatory policy.

An important role for medical research regulatory policy is ensuring the quality of evaluated prospective medicines. In the case of regenerative stem cell medicine, meeting this charge was not fully possible previously. No suitable methods existed for quality control evaluation of the essential stem cells in treatment samples. Asymmetrex now markets a technology for this purpose. On the panel, Sherley will address how the availability of a means for determining treatment stem cell quality and dose may impact future developments in stem cell medical research regulatory policies.

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 quality and dose of tissue stem cell preparations (the “AlphaSTEM Test”) for use in stem cell transplantation therapies and in pre-clinical assays for drug safety.

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AsymmetrexAsymmetrex Joins RegMedNet Panel to Discuss Cell Therapy Regulation

Asymmetrex Comments on Positive Attributes of Private Stem Cell Clinics

by Asymmetrex on June 8, 2017

The usual commentary on private U.S. clinics currently evaluating new stem cell treatments is stereotypically negative, with accusations of peddling exploitive and dangerous therapies. However, a recently published comment from the Director of Massachusetts stem cell biotechnology company Asymmetrex considers that many of the treatments provided by private stem cell clinics could be as important to progress in stem cell medicine as FDA-authorized clinical trials.

Boston, MA For Immediate Release

In a new early view article published in the online Journal of Stem Cell Research and Medicine, James L. Sherley, M.D., Ph.D., founder and director of Asymmetrex, LLC, asks the question, “Why are patients scared away from private stem cell clinics?” (June 6, 2017). Sherley presents a critical assessment of the warnings pronounced by federal agencies and professional organizations, like the National Institutes of Health (NIH) and the International Society for Stem Cell Research (ISSCR), against private clinics providing stem cell treatments. He argues that new treatments in private clinics are, for the most part, not very different than stem cell treatments in clinical trials authorized by the Food and Drug Administration (FDA).

In his comment, Sherley chides the NIH, ISSCR, and alarmist commentators for portraying private stem cell clinics, as a group, as unethical, and even dangerous to patients, without good evidence to support their claims. He provides examples to show that many operational elements of stem cell treatments in private clinics are not unlike FDA-authorized clinical trials. Both stem cell treatment settings have strengths and weaknesses. Sherley’s position is that, “In their missions to serve patients, the NIH’s and ISSCR’s efforts would seem to be better spent informing patients how to obtain the best care in either setting.” In earlier writings and presentations, he has also urged decision-makers to develop policies for collecting, organizing, and studying stem cell treatment data from private clinics. Since the number of patients treated in private clinics is now estimated to far exceed the number in clinical trials, Sherley has argued that excluding this valuable experience by vilifying it is a tragic loss to stem cell medical research and patients.

A crucial way in which FDA-authorized clinical trials and private stem cell treatment clinics are not different is their past lack of a means to determine the dose and quality of stem cell treatments. In his published comment, Sherley notes that none of the anti-private clinic alarmists acknowledges this deficiency that also impacts the worth of stem cell clinical trials. In fact, this need even limits the quality of some approved stem cell therapies like umbilical cord blood stem cell transplant.

Asymmetrex has recently developed a technological solution for the half century-old problem of specifically counting tissue stem cells. With the company’s new technology, it is now possible to determine the dose and quality of therapeutic tissue stem cell preparations. Asymmetrex is positioned to become the certifying agency for the dose and quality of tissue stem cells used in approved treatments and either FDA-authorized clinical trials or private stem cell clinic treatments. Sherley predicts that adoption of this shared certification process will promote a more reasoned assessment of the contributions that private stem cell clinics are and can make to accelerating progress in stem cell medicine.

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AsymmetrexAsymmetrex Comments on Positive Attributes of Private Stem Cell Clinics

Asymmetrex Named One of the “50 Most Valuable Brands of the Year 2017”

by Asymmetrex on May 18, 2017
Yesterday, when Silicon Valley magazine The Silicon Review announced its 2017 class of 50 Most Valuable Brands, one member, private stem cell biotechnology start-up Asymmetrex, may have seemed an unusual selection. However, the company’s unique in silico approach to counting therapeutic tissue stem cells earned it this recognition.

When James Sherley, was notified earlier this year that his company Asymmetrex had been selected as one of the 50 Most Valuable Brands for the Year 2017 by The Silicon Review, he was not surprised as others might be. Sherley says, “I felt like we had been making good progress increasing Asymmetrex’s value, but this recognition by Silicon Valley was particularly meaningful. Our selection by The Silicon Review may seem odd to some, but it makes perfect sense to us. We are able to count adult tissue stem cells for the first time, how? By adapting and designing in silico computational simulation techniques to reveal previously unmeasured properties of adult tissue stem cells, like for instance their number!”

Sherley had a theoretical concept for counting tissue stem cells since before he and his collaborators published a 2001 seminal report explaining how the culture of human tissue cells depends on the unique cell production abilities of tissue stem cells. However, implementing and testing his concept would require enlisting computational modeling expertise. Although Sherley was a professor at MIT, during his time there from 1998 to 2007, he was able to entice only one computer science graduate student to work with him on the idea as a half-semester interdisciplinary experience project.

Then Sherley met Frank Abdi, Ph.D. at a biology-mesomechanics integrative conference in Vicenza, Italy in 2011. Abdi is the founder and chief scientist at AlphaSTAR Corporation, a leading global consulting company in the aircraft and aerospace industry. In AlphaSTAR, Abdi had developed an award-winning, proprietary suite of statistical computational software for simulating the complex behavior of composite materials in high mechanical stress crafts like airplanes, racing cars, and space shuttles. Abdi had a long-standing interest in applying these malleable computational tools to problems in medicine. So, it did not take long for Abdi and Sherley to recognize that they were the ideal team to advance Sherley’s computational tissue stem cell counting concept to practical use.

With other AlphaSTAR staff, the two began by translating Sherley’s biological models into computational code. When Asymmetrex was formed in 2013, the two companies added staff and resources to accelerate their efforts to develop and validate the new counting approach. By the middle of 2016, they had completed development of the AlphaSTEM Test, a working software program validated for counting tissue stem cells in human lung, bone marrow, liver, and amniotic fluid, as well as for detecting tissue stem cell-active compounds like drug candidates. The data input required for the AlphaSTEM Test is easily obtained total cell count data from serial culture of dissociated human tissue cells.

Asymmetrex now markets the AlphaSTEM Test with the computing support of AlphaSTAR. Before the AlphaSTEM Test, there was no method available for counting adult tissue stem cells specifically. Now, it is possible to count tissue stem cells in experiments in research labs; to determine the dose of stem cells in approved stem cell therapies; to determine the quality and dose of stem cells used in private stem cell clinic treatments; to determine stem cell dose for better interpretation of stem cell clinical trial results; to monitor and optimize biomanufacturing processes for therapeutic tissue stem cells; to determine the dose of genetically-engineered stem cells in gene and gene editing therapies; to have earlier screening for stem cell-toxic drugs that fail in clinical trials because of chronic organ failure; to identify environmental toxicants that alter tissue stem cells; and to identify compounds that improve health by positive effects on tissue stem cells.

The many benefits that will flow from now being able to address these many waiting unmet needs and markets are the basis for The Silicon Review’s recognition of Asymmetrex’s high value in 2017 and beyond.

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. Currently, Asymmetrex’s focus is employing its technological advantages to develop and market facile methods for monitoring adult stem cell number and function in stem cell transplantation treatments and in pre-clinical assays for drug safety.

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AsymmetrexAsymmetrex Named One of the “50 Most Valuable Brands of the Year 2017”

Asymmetrex Presents New Contract Service for Adult Tissue Stem Cell Counting at CGX17

by Asymmetrex on May 16, 2017
On May 23 in Washington, D.C., stem cell medicine biotechnology start-up Asymmetrex will present its new contract service for adult tissue stem cell counting applications to company representatives attending Cell & Gene Exchange 2017. CGX17, the first partnering conference organized by the Alliance for Regenerative Medicine, will be attended by stem cell therapy, gene therapy, gene editing, and pharmaceutical companies, all who would benefit from Asymmetrex’s technology for counting adult tissue stem cells.

On Tuesday, May 23 at 10:30 AM, James Sherley, Director of Asymmetrex, will have an ideal audience for introducing the advance in stem cell medicine that his company has recently achieved in collaboration with its partner, AlphaSTAR Corporation. Tuesday will be the second day of the Alliance for Regenerative Medicine’s first partnering conference, Cell & Gene Exchange 2017. In addition to his formal talk, Sherley will meet with interested companies in one-on-one partnering sessions to introduce them to the many advantages that Asymmetrex’s AlphaSTEM Test service offers.

Asymmetrex and AlphaSTAR partnered to develop the first method for specific counting of adult tissue stem cells. The AlphaSTEM Test is the result of the integration of Asymmetrex’s expertise in the unique cell production behavior of tissue stem cells and AlphaSTAR’s cutting-edge methods in computational simulation. By a proprietary analysis of simple cell growth data from cultures containing adult tissue stem cells, the AlphaSTEM Test technology can determine, with a high degree of precision, the number and behavior of tissue stem cells in complex cell preparations from many different types of human tissues.

For stem cell therapy companies, the AlphaSTEM Test offers the ability to determine stem cell dose for the first time. Currently, the only clinical test available for estimating whether treated patients have received sufficient stem cells is the CD34 marker for blood stem cells. However, because it does not give a specific blood stem cell dose, CD34 has poor sensitivity and specificity. The weak efficacy that CD34 does provide is limited primarily to blood stem cells. The AlphaSTEM Test offers the ability to determine specific dosing for stem cells from many different tissues.

Gene therapy and gene editing companies that genetically engineer blood stem cells – called hematopoietic stem cells (HSCs) – could also benefit from the AlphaSTEM Test service. HSCs are the targets for gene treatments because they are the only blood cells that are naturally maintained in the body for the long periods required for stable genetic cures. Because human HSCs are rare cells even in the most enriched clinical preparations, their starting number and their remaining number, respectively before and after genetic engineering procedures, are important data for optimization of the engineering and ensuring that sufficient modified HSCs are available for effective treatment.

Though minor participants in the conference, Asymmetrex will also address pharmaceutical companies. Asymmetrex has established that the AlphaSTEM Test can be employed to identify stem cell-active agents. The test has been validated with known stem cell-toxic drugs and stem cell-activating compounds. The current main service focus for Pharma is stem cell-toxic drug candidates. Stem cell toxicity causes chronic organ failure, a property that generally means a failed drug. Twenty to 30 percent of all drugs fail in Phase II and Phase III clinical trials due to intolerable toxicity. About half of these failures are due to chronic organ failure, which costs the average large pharmaceutical company $100-300 million each year. Asymmetrex’s AlphaSTEM Test could identify many of these future failures much earlier, even before animal studies, giving substantial savings to pharmaceutical companies in real dollars and patient safety. The impact would be even greater for drugs that did not manifest chronic organ failure until after they were in the marketplace.

Asymmetrex launched the AlphaSTEM Test contract service in September 2016. Thus far, adoption of the new technology has been measured. Asymmetrex’s presentation at Cell & Gene Exchange 2017 is part of the company’s mounting marketing campaign to increase awareness of the new technology in relevant fields. In addition to marketing to prospective clients, the company is discussing potential distribution partnerships with established contract research and contract medical organizations. Director Sherley is optimistic that “this is a technology that will become a must have for everyone and anyone working with adult tissue stem cells. If you are investigating them, treating with them, testing drugs with them, or supplying them, how could you pass up now knowing how many they are?”

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. Currently, Asymmetrex’s focus is employing its technological advantages to develop and market facile methods for monitoring adult stem cell number and function in stem cell transplantation treatments and in pre-clinical assays for drug safety.

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AsymmetrexAsymmetrex Presents New Contract Service for Adult Tissue Stem Cell Counting at CGX17

Introducing First Quality Control Test for Therapeutic Tissue Stem Cells

by Asymmetrex on March 14, 2017

On March 8-9 in Boston, stem cell medicine biotechnology start-up Asymmetrex led attendees at the 6th Annual Clinical Trials Supply New England 2017 conference in discussions about the need for quality controls for the supply of tissue stem cells used for treatments in either FDA-approved clinical trials or unregulated private stem cell clinics. Though these two stem cell treatment settings are often contrasted regarding their safety and effectiveness, Asymmetrex stressed that patient care and research progress is compromised in both because of the lack of essential quality control tests for the number and quality of transplanted tissue stem cells.

At the 6th Annual Clinical Trials Supply New England 2017 conference, held in Boston from March 8-9, James Sherley, M.D., Ph.D., director of Asymmetrex, led discussions that evaluated the quality of U.S. supplies of stem cells used in clinical trials compared to private stem cell clinics. Private stem cell clinics have been criticized for not employing research standards that are necessary to establish the therapeutic effectiveness of treatments with statistical confidence. In part because of this difference in practice, they are also often accused of making unproven claims about the effectiveness of their therapies.

Sherley presented comparisons of key operational elements to argue that, given good intent in both settings, the two different settings of stem cell treatments had both distinct and shared shortcomings. He noted, however, that the most significant shortcoming, which stem cell clinical trials and private stem cell clinics share, was perennially overlooked.

Based on the number of reported stem cell clinical trials and private stem cell clinics, Sherley estimated that close to a quarter-million patients in the U.S. now receive stem cell treatments each year. Though many of these occur within FDA-approved clinical trials, their number is dwarfed nearly 10 times by the number of treatments that occur in private stem cell clinics. It shocked the audience of clinical trial suppliers to learn that there was no stem cell quality control test performed for any of these many treatments.

Even for approved stem cell medicine treatments like bone marrow transplantation and umbilical cord blood transplant, there is no stem cell-specific quality control test available. Counts of total cells are made, but these do not adequately predict stem cell number or function. Biomarkers designated for tissue stem cells are also expressed by stem cells’ more abundant non-stem cell products. So, the biomarkers lack sufficient specificity to be used to count and monitor tissue stem cell function.

Without a quality control test for tissue stem cell number, stem cell treatments in all settings proceed without knowing the dose of treating tissue stem cells. This previously unavoidable therapeutic blind spot creates an instant treatment risk. It also precludes effective analyses to optimize treatment procedures, to compare different treatments, or to relate treatment outcomes to tissue stem cell dose. Without knowing stem cell dose, the interpretation of any stem cell treatment in terms of stem cells as the responsible agents is compromised.

In this context, Sherley announced briefly to attendees that Asymmetrex’s new AlphaSTEM Test for counting adult tissue stem cells and providing data on their viability and tissue cell renewal function represented the needed first quality control test for tissue stem cell treatments, whether in clinical trials, in private stem cell clinics, or approved therapies. In particular, he indicated that both stem cell treatment patients and progress in stem cell medicine would benefit from existing clinical trial supply companies developing into future private stem cell clinic supply companies to ensure the quality of stem cell treatment preparations. Sherley said that, of course, their partnership with Asymmetrex to implement its new stem cell-specific quality control test was an all around best solution for accelerating progress in stem cell transplantation 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. Currently, Asymmetrex’s focus is employing its technological advantages to develop and market facile methods for monitoring adult stem cell number and function in stem cell transplantation treatments and in pre-clinical assays for drug safety.

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AsymmetrexIntroducing First Quality Control Test for Therapeutic Tissue Stem Cells

Asymmetrex’s Head Will Lead Discussion on Supplying Private Stem Cell Clinics

by Asymmetrex on March 7, 2017

On March 8-9 in Boston, stem cell medicine biotechnology start-up Asymmetrex will take the lead in introducing a potentially controversial topic to attendees at the 6th Annual Clinical Trials Supply New England 2017 conference. Executives from contract research organizations that supply companies running FDA-approved stem cell clinical trials will be presented with the proposition of promoting advances in stem cell medicine by also supplying private clinics that offer medical treatments with adult tissue stem cells.

Recent scientific reports put the number of private clinics offering stem cell medical treatments in the U.S. at greater than 400. More than 300 of these clinics emerged since 2009. They mirror the rapid increase in FDA-approved clinical trials during the same period at a rate of about 300 new therapy-focused adult tissue stem cell trials each year. However, because of the inherently small number of patients enrolled in early clinical trials and the much larger number of patients seen in medical clinics, the number of stem cell treatments performed in private clinics dwarfs the number in clinical trials by more than 10-fold.

In both settings, treatment cell transplants per se appear generally safe, as long as proper care is given to other routine safety factors, which include mainly keeping treatments free of infectious agents and chemical contaminants and avoiding immune reactions. These safety procedures fall well within the training and expertise of physicians in private clinics, as well as in hospital-based clinical trials.

The rapid growth of private stem cell clinics has alarmed some stem cell scientists and their member organizations. The clinics are accused of making false claims, exploiting patients’ pain and distress for financial gain, and generally harming the reputation of stem cell science. In contrast, in FDA-approved clinical trials, patient volunteers are necessarily informed that their treatments are experimental, and therefore may bring them no medical benefit. Generally, trial subjects do not pay for their treatment, though often treatment costs are covered by their personal health insurance.

Asymmetrex’s founder and director, James L. Sherley, M.D., Ph.D., recently began a public discourse, in which he argues that in the important respects private stem cell clinics are not all that different than FDA-approved clinical trials. First, he says that glibly painting all several hundred or more private stem cell clinics as exploitive is an unsubstantiated claim itself. Generally, physicians in both settings are diligently looking for ways to improve the health of patients – clinical trial physicians in the more distant future and private clinic physicians immediately. Sherley, a physician scientist, stresses the importance of recognizing medical empiricism as an important contributor to the advance of modern medicine and medical science.

At the conference, Sherley is scheduled to lead a panel discussion on the topic on March 8 at 15:50 PM (EDT) and give a talk on March 9 at 13:30 PM (EDT). A major new position he will present is that the volume of stem cell treatments now occurring in private clinics is much too large to simply disparage and attempt to shut down. Working to improve the quality of private stem cell clinic treatments for patients and to improve their documentation towards accelerating progress in stem cell medicine is a better goal.

To attendees at this week’s Clinical Trials Supply conference, Sherley will suggest that the supply of private stem cell clinics with high quality, certified sources of stem cells is an underappreciated crucial need for advancing stem cell medicine. The companies that are able to mobilize to fill in this supply gap could have a 10-fold greater impact on advancing stem cell medicine compared to their current minimal impact in FDA-approved stem cell clinical trials.

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. Currently, Asymmetrex’s focus is employing its technological advantages to develop and market facile methods for monitoring adult stem cell number and function in stem cell transplantation treatments and in pre-clinical assays for drug safety.

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AsymmetrexAsymmetrex’s Head Will Lead Discussion on Supplying Private Stem Cell Clinics

Asymmetrex Director Shares Vision for Company

by Asymmetrex on November 17, 2016
On November 15, James L. Sherley, M.D., Ph.D., Director of stem cell biomedicine technology company Asymmetrex, contributed nearly simultaneously to two related Arena International Events Group forums for clinical trials development. While presenting Asymmetrex’s stem cell medicine business vision at the event group’s 1st Annual Preclinical Development Operations Conference in Boston, a new perspective written by Sherley was published online at the Arena International news site for addressing challenges in clinical trials operations.

Asymmetrex Director Shares Vision for Company and Private Stem Cell Treatment Clinics in Two Arena International Event Group Forums

“Asymmetrex is on the path to success.” James Sherley, director of Asymmetrex, confidently spoke these words when he recounted the business development progress of the company that he founded three years earlier. Sherley was speaking at the 1st Annual Preclinical Development Operations Summit, organized by Arena International Events Group, on November 15-16, in Boston.

Developing more effective collaboration and partnership between contract research organizations (CRO) and their pharmaceutical company and cell therapy company sponsors was the major focus of the Summit. However, in addition to attendance by heads of drug development and cell therapy development from well-established companies, the Summit also included executives from new pharmaceutical and CRO start-ups. Asymmetrex, having recently launched a new contract service that provides, for the first time, tissue stem cell counting for both support of drug development and stem cell therapeutics, was invited to present. Director Sherley reviewed the company’s current business strategy and its longer-term vision of leveraging the new CRO business towards future success as an adult tissue stem cell biomanufacturing company.

Fifteen minutes before Sherley began his presentation on the first day of the Summit, at 12 pm EDT, the clinical trials news site of Arena International published a new perspective from him on the importance of private stem cell treatment clinics to the future of stem cell biomedicine. The article considers that these clinics have been generally mischaracterized regarding their motivation and their research merit. Sherley emphasizes that their presently unregulated stem cell treatments are a part of the long tradition of routine medical practice also serving as a source of scientific discovery and medical innovation. The article makes recommendations for improvements in current treatment practices in private clinics that would increase the quality of care and the utility of knowledge obtained to accelerate progress in stem cell 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. Currently, Asymmetrex’s focus is employing its technological advantages to develop and market facile methods for monitoring adult stem cell number and function in stem cell transplantation treatments and in pre-clinical assays for drug safety.

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AsymmetrexAsymmetrex Director Shares Vision for Company