Unlike all other medicines, the dose of treatment stem cells continues to be ignored.
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.
BOSTON (PRWEB)
October 03, 2019
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.”
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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