The U.S. stem cell therapy and regenerative medicine industry and patients are presently awaiting recently promised new policies from the FDA to improve guidance and oversight for experimental stem cell treatments in both private clinics and authorized clinical trials. Massachusetts stem cell biotech company Asymmetrex proposes that its new technology for certifying the specific dose and quality of tissue stem cells used in experimental treatments would improve the FDA’s efforts.
Asymmetrex Proposes Its Technology for Certifying Therapeutic Stem Cell Dose and Quality To Support Anticipated New FDA Policies for Experimental Stem Cell Treatments
The first suggestion for the FDA was given on September 15 in Kansas City, a little more than two weeks after FDA Commissioner Gottlieb issued a reproach to “bad actors,” who provide experimental stem cell treatments, while representing them as if proven to be effective. At the 5th Midwest Conference on Cell Therapy and Regenerative Medicine, Dr. James L. Sherley, M.D., Ph.D., founder and director of Asymmetrex, shared his vision for the company’s technology for counting therapeutic tissue stem cells, for the first time, with a national audience of cell therapy companies, stem cell transplant physicians, patient advocates, and local elected officials. He stated that, “Any new FDA policy would be improved, if it included a requirement to certify the dose and quality of stem cell treatments.”
Sherley has argued earlier that requiring routine quantification of the number and quality of tissue stem cells is not only important for the practice of stem cell clinics, but also for the quality of FDA-authorized stem cell clinical trials. Like private clinics, current clinical trials proceed without knowing the number of tissue stem cells delivered. Stem cells are a very small fraction of the total cells administered for treatments. Biomarkers for their identification are not specific. Currently available biomarkers erroneously identify many cells as stem cells that are not stem cells, and which greatly outnumber stem cells. This situation makes current stem cell clinical trials difficult to interpret, to say the least. Actually, in terms of the critical elements for evaluation, transplanted stem cells, many trials are impossible to interpret at all.
Asymmetrex’s AlphaSTEM Test™ technology is able to count tissue stem cells specifically and measure their ability to renew mature tissue cells. This test could be used to certify the dose of active stem cells in treatments. Sherley insists, “What could be more important for the assessment of safety and efficacy? No different than drug evaluations.” In fact, Sherley would also like to see the FDA recommend to pharmaceutical companies that they evaluate their drug candidates for toxicity against tissue stem cells. Stem cell-toxic drugs cause chronic organ failure, which accounts for about half of drug failures due to safety problems in Phase II and III clinical trials. So, Sherley projects that industry-wide implementation of Asymmetrex’s stem cell counting technology to screen-out stem cell-toxic drug candidates, before animal studies and clinical trials, could save the U.S. pharmaceutical industry $4-5 billion each year. Such a large impact could lead to a general lowering of the cost of drugs to patients.
Later this month, Asymmetrex will continue its campaign to engage the FDA’s interest in the benefits of including certifications for stem cell dose and quality in its highly anticipated new stem cell treatment policies. Director Sherley will renew his proposal in a presentation at the 2017 Pre-clinical Development Operations Summit in Boston, October 31-November 1.
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.