The founder and director of stem cell biotechnology company Asymmetrex, James L. Sherley, M.D., Ph.D., continues to lead the company’s campaign to educate the regenerative medicine community on its overdue implementation of new stem cell dose standardization technologies developed by his company. In a May 31 invited essay posted on the Operations webpage of ClinicalTrialsArena, Sherley revs up his effort by noting that long established, but flawed, certifications by some cell therapy regulatory agencies are major perpetuators of the problem.
“Until the regenerative medicine industry takes care of its stem cell dose problem, it will continue to be an under achieving medical discipline.” That is the message of the newest article published in the ongoing educational campaign of James L. Sherley, the founder and director of stem cell biotechnology company Asymmetrex.
The invited article was published online, May 31, by ClinicalTrialsArena on its Operations webpage. It addresses the longstanding unmet need in the regenerative medicine industry for a method to standardize the dose of stem cell treatments.
As an international web portal for targeting the clinical trials supply industry, ClinicalTrialsArena organizes conferences and provides informational content to address key challenges in supplying global clinical trials with materials and technologies, including the growing area of stem cell clinical trials. The newly posted article is also a call to contract research and medical organizations to motivate and assist their stem cell clinical trial clients towards achieving the long needed milestone of stem cell dose application.
The new article is the latest in a series of commentaries published by Sherley in the past two years as a part of Asymmetrex’s campaign to inform both the regenerative medicine industry and the pharmaceutical industry of the advantages of using the company’s AlphaSTEM Test™ technology to quantify tissue stem cell number and dose for the first time. Most recently, in a commentary published in the March 2018 issue of Pharmaceutical Manufacturing, Sherley noted that the lack of stem cell dose standardization was a major impediment keeping pharmaceutical companies from investing in stem cell medicine.
In the new article, the role of regulatory agencies as enablers of dose-less stem cell clinical trials and medical treatments is a major consideration. In particular, the exposé is critical of the U.S. Food and Drug Administration and the international Foundation for the Accreditation of Cellular Therapy. The FDA does not require stem cell dose as a quality criteria for stem cell clinical trials and treatments; and FACT persists in mandating blood bank certification tests that are well known to be ineffective for determining stem cell potency.
Although Asymmetrex is impatient to get its new technology for stem cell dose determination into wider use, the company and its director understand the measure of time for such a sea change in a medical science discipline. In addition to its industry-wide public education campaign, the company is actively forging partnerships with key leaders in stem cell therapy communities. As Sherley closes his commentary, “if a new technology is effective for standardizing stem cell dose, its adoption is inevitable.”
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.Read More