If the FDA is starting to insist that that we have stem cell-specific dose for therapies, for clinical trials we are going to need it for supply as well.
BOSTON (PRWEB) May 13, 2020
On May 12, the director of stem cell biotechnology company Asymmetrex continued to demonstrate the reach of his company’s tissue stem cell counting technology into all aspects of the stem cell regenerative medicine industry. Speaking online in Arena International’s Clinical Trial Supply 2020 conference, James Sherley, M.D., Ph.D. outlined how achieving a more effective supply chain for stem-gene therapy clinical trials will require the industry to advance to certification of the stem cell-specific properties of transported cell and gene therapies. Because of disruptions caused by the current global COVID19 crisis, this year’s annual conference was organized as a virtual experience online.
Asymmetrex’s AlphaSTEM Test™ technology is the first and only technology that can specifically quantity therapeutic tissue stem cells. The technology is applicable to therapies deploying either natural or genetically-engineered tissue stem cells. In his presentation, Sherley highlighted the prevalent misconception that therapeutic tissue stem cells can be counted by flow cytometry. Tissue stem cells cannot be counted by flow cytometry. Counting by flow cytometry requires biomarkers that specifically identify tissue stem cells. To date, despite years of attempts, such biomarkers have not been discovered.
In an earlier podcast series on “Counting Stem Cells” featured on the international stem cell industry networking platform RegMedNet, Sherley discussed the benefits of Asymmetrex’s technology to stem-gene therapy patients by providing essential dose information for their treatments. In his clinical trial supply presentation, he related the importance of the same care in ensuring that the potency and quality of stem cell treatments are preserved during transport for supply of stem-gene clinical trials.
Sherley also alerted his clinical trial supply audience to recent developments on the FDA regulatory landscape that are likely to impact future supply practices for stem-gene clinical trials. “If the FDA is starting to insist that that we have stem cell-specific dose for therapies, for clinical trials we are going to need it for supply as well.” Sherley based this prediction on a recent industry document developed by the FDA’s Standards Coordinating Body’s that identifies determination of unknown cell-specific doses as a needed standard for regenerative 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 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 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. Asymmetrex is a member company of the Advanced Regenerative Manufacturing Institute BioFabUSA and the Massachusetts Biotechnology Council.