Asymmetrex Talks with Tech Company News About Introducing Tissue Stem Cell Counting to the Advanced Regenerative Manufacturing Institute (ARMI)

by Asymmetrex

Online news platform Tech Company News caught up with Asymmetrex Director James Sherley to ask him about his expectations for Asymmetrex’s new membership in ARMI.

“Working with our partner AlphaSTAR Corporation, Asymmetrex has solved the first problem. We now offer the first ever technology for specific and accurate counting of any human tissue stem cell type, including blood stem cells, liver stem cells, stem cells derived from fat, and others under evaluation for medical applications. This expertise and technology is what we bring to ARMI BioFabUSA with our new membership.”

Their interview is posted here!

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Advanced Regenerative Manufacturing Institute Highlights New Partnership with Asymmetrex

by Asymmetrex

Recently, Asymmetrex LLC joined forces with a new public-private Manufacturing USA Initiative, the Advanced Regenerative Manufacturing Institute (ARMI). ARMI highlighted Asymmetrex in its New Member Spotlight.

This member spotlight goes into detail about the crucial hurdle regenerative medicine is currently facing — a quantitative discipline for tissue stem cells. Dr. James Sherley speaks to ARMI about just this and how Asymmetrex’s technology will put an end to this:

“Achieving this shift in technical practice and conceptual perspective would immediately address several other hurdles that are more widely acknowledged.  Examples include evaluating the efficacy of stem cell clinical trials with small sample size; developing industry standards for certifying the stability of transported stem cell therapies; defining the potency of stem cell treatments.  The currently limited FDA guidance for human cell, tissue, and cellular and tissue-based products (HCT/P) might also be improved by incorporating a stem cell-specific dose basis,” Sherley explained.

Read the full Member Spotlight here!

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Asymmetrex Partners in Manufacturing USA Institute

by Asymmetrex

The Advanced Regenerative Manufacturing Institute (ARMI) will receive more than $300 million in public-private investment from leading manufacturers, universities, nonprofit organizations and the federal government to develop scalable manufacturing processes for engineered tissues and organs.

Asymmetrex LLC is part of a new public-private Manufacturing USA initiative, the Advanced Regenerative Manufacturing Institute (ARMI). Headquartered in Manchester, New Hampshire, ARMI is the 12th Manufacturing USA Institute. ARMI brings together a consortium of over 100 partner organizations from industry, government, academia and the non-profit sector to develop next-generation manufacturing processes and technologies for cells, tissues and organs.

Approximately $80 million from the federal government will be combined with more than $200 million in cost share to support the development of tissue and organ manufacturing capabilities. As part of continuing efforts to help revitalize American manufacturing and incentivize companies to invest in new technology development in the United States, ARMI will lead the Advanced Tissue Biofabrication (ATB) Manufacturing USA Institute on behalf of the Department of Defense.

Under the umbrella of Manufacturing USA, a public-private network that invests in the development of world-leading manufacturing technologies, ARMI will work to integrate and organize the fragmented collection of industry practices and domestic capabilities in tissue Biofabrication technology to better position the US relative to global competition. ARMI will also focus on accelerating regenerative tissue research and creating state-of-the-art manufacturing innovations in biomaterial and cell processing for critical Department of Defense and civilian needs.

“We need to develop 21st century tools for engineered tissue manufacturing that will allow these innovations to be widely available – similar to how a 15th century tool (the printing press) allowed knowledge to spread widely during the Renaissance,” said inventor Dean Kamen, ARMI’s chairman.

ARMI’s efforts are supported by forty-seven industrial partners, twenty-six academic and academically affiliated partners, and fourteen government and nonprofit partners. The ARMI partnership continues to grow.

About Asymmetrex
Asymmetrex, LLC is a Massachusetts life sciences company with a focus on developing technologies to advance stem cell medicine. 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. 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. For more information, please visit https://www.asymmetrex.com.

About ARMI
The Advanced Regenerative Manufacturing Institute (ARMI), headquartered in Manchester, NH, is the 12th Manufacturing USA Institute. It brings together a consortium of over 150 partners from across industry, government, academia and the non-profit sector to develop next-generation manufacturing processes and technologies for cells, tissues and organs. ARMI will work to organize the current fragmented domestic capabilities in tissue Biofabrication technology to better position the U.S. relative to global competition. For more information on ARMI, please visit http://www.ARMIUSA.org.

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Director Sherley Offers Recommendations for Improving Ethical Conduct During Academic Journal Peer-Review

by Asymmetrex

Asymmetrex Founder and Director James L. Sherly, M.D., Ph.D. recently wrote an article for The Scientist magazine that addresses the ethics around the peer-review of academic manuscripts submitted for publication in research journals.

“Whether co-reviewers are named or not, this practice, along with the more patently unethical ghostwriting, has no defensible place in the live arena of academic publishing.”

Learn more about this article from Dr. Sherley’s perspective and how he faces similar challenges with Asymmetrex’s new technology.

LEARN MORE >

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New Podcast Sponsored by Asymmetrex Increases Awareness to the Need for Stem Cell Dose in Stem Cell Treatments

by Asymmetrex

Massachusetts stem cell biotechnology company Asymmetrex began sponsorship of a new informational podcast in October of this year. Titled “Counting Stem Cells For A New Era Of Medicine,” the educational podcast explains and amplifies the FDA’s recent attention to a long-standing, significant deficiency in stem cell medical practice, giving patients stem cell treatments without knowing the dose of stem cells.

In October, Massachusetts stem cell biotechnology company Asymmetrex launched a new podcast to provide information to patients about a poorly disclosed deficiency in stem cell treatments. Throughout stem cell medical practice, stem cell treatments are given without knowing the dose of the treating stem cells. This problem affects all patients receiving stem cell treatments, including patients receiving approved treatments in routine clinical practice, patients volunteering for experimental treatments in FDA-authorized clinical trials, and patients obtaining unapproved treatments in private stem cell clinics.

The costs and dangers of unknown stem cell dose in treatments are significant. Stem cell clinical trials cannot be interpreted without knowing the treatment dose, leading to huge wastes of both federal and private clinical research dollars. In the case of manufactured stem cells, many treatments may contain very few or no stem cells at all. It is impossible for doctors to improve treatments without knowing the stem cell dose. Stem cell donors for approved treatments like blood stem cell transplantation are scarce. Knowing the stem cell dose would allow doctors to know when a treatment sample has enough stem cells to treat more than one patient; or when it does not have enough to treat even a single patient. In the second case, not knowing the stem cell dose can result in the death of children treated for leukemia when unknowingly they receive an umbilical cord blood transplant with too few blood stem cells to save them. 

Earlier this year, the FDA recognized the pressing need for stem cell dose in stem cell medicine. The agency’s Standards Coordinating Body for Regenerative Medicine (SCB) listed stem cell dose determination as a priority for needed standards for stem cell medicine. Dose is a fundamental principle for the discovery, development, and administration of quality medicines. Asymmetrex Director James L. Sherley, M.D., Ph.D., who is featured in the new podcast, says that, “Dose is essential for stem cell medicine as well. The new podcast has the goal of informing the end users of stem cell treatments: the patients, their doctors, their families, and their advocates, including the FDA. When the people most impacted by these treatments understand that knowing the dose of stem cells is just as important as knowing the dose of their other medicines, they will be empowered to demand this essential certification of the integrity of their stem cell treatments.” 

The first episode of the podcast, “Counting Stem Cells For A New Era Of Medicine,” aired online on October 17. The third episode of the biweekly, 6-episode series is scheduled for airing November 12. Each episode features an interview of Asymmetrex Director Sherley by podcast producer Jordan Rich. Mr. Rich guides Dr. Sherley through a discussion of questions that reveal the current challenges that Asymmetrex is addressing to achieve full adoption of stem cell dose as a routine practice in stem cell medicine. The series also highlights other significant applications for stem cell counting in drug development and environmental health science. In conjunction with this educational effort, the company is also sponsoring a study on its website to evaluate the current state of public, academic, and industry knowledge of coming changes in stem cell medicine related to the adoption of stem cell dose. 

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 TestTM”) for use in stem cell transplantation therapies and pre-clinical drug evaluations.

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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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