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.
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.