The Stem Cell Dosage Knowledge Gap
“If dose is an essential principle in medicine, then it is also an essential requirement in stem cell medicine.”
BOSTON (PRWEB)
March 25, 2021
The 2021 Virtual Conference on Clinical Trial Supply-Europe, organized by Arena International, started yesterday, March 24, and is continuing through today. More and more, clinical trial supply conferences are featuring speakers and forums that address the growing number of stem cell clinical trials. Stem cell biotechnology company Asymmetrex’s founder and CEO, James L. Sherley, M.D., Ph.D., presented a talk with this perspective on the opening day of the conference.
Sherley began his talk by highlighting the large and growing market for the supply of stem cell clinical trials, estimated to be about $10B in 2020 and projected to grow to $20B by 2027. The significant size of this supply chain market is indicative of the rapid growth of the stem cell clinical trials industry that depends on it.
Sherley’s presentation disclosed how a long-standing knowledge gap in stem cell medicine currently limits the effectiveness of the stem cell clinical trial supply chain. He discussed how the need for a means to quantify therapeutic tissue stem cells undermines the quality of every step of the supply chain. In previous Arena International clinical trials supply conferences, Sherley has discussed how the same need compromises the effectiveness of stem cell clinical trials themselves.
The main purpose of the presentation was to continue Asymmetrex’s efforts to introduce the stem cell clinical trial supply chain industry, and stem cell medicine in general, to emerging technologies that address the unmet need for a method to quantify the dosage of therapeutic stem cells. He emphasized that, “If dose is an essential principle in medicine, then it is also an essential requirement in stem cell medicine.”
In his talk, Sherley related how, recently, the FDA has been increasing attention on the problem of unknown cell-specific doses – which translates as stem cell-specific doses – in cellular therapies; and these developments were motivated in part by the emergence of new technologies for accurate determination of the dosage of therapeutic tissue stem cells. Asymmetrex’s business model is ending this current knowledge gap to increase the effectiveness of stem cell clinical trials and the growing industry that supplies them.
Asymmetrex, LLC is a Massachusetts life sciences company with a focus on developing technologies to advance stem cell medicine. The company’s U.S. and U.K. patent portfolio contains biotechnologies that solve the two main technical problems – production and quantification – that have stood in the way of effective use of human adult tissue stem cells for regenerative medicine and drug development. Asymmetrex markets the first technology for determination of the dose and quality of tissue stem cell preparations for use in stem cell transplantation therapies and pre-clinical drug evaluations. Asymmetrex is a member company of the Advanced Regenerative Manufacturing Institute BioFabUSA and the Massachusetts Biotechnology Council.
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