Dose is essential for stem cell medicine as well.
BOSTON (PRWEB) November 06, 2019
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.
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.