Boston, MA (PRWEB) June 22, 2017
For the months of May and June, United Kingdom-based social media network RegMedNet has produced a Spotlight series on “Cell Therapy Regulation” for its regenerative medicine followship. The series has featured scholarly reviews and perspectives by leading experts on the unique regulatory challenges of stem cell medical research.
Stem cell clinical trials present unique regulatory challenges that are not an issue in conventional pharmaceutical and biopharmaceutical clinical research. On the one hand, introducing patients’ own cells, and even cells from matched donors, so far has been observed to be a relatively safe medical procedure. However, the small numbers of patients enrolled in clinical trials thus far have precluded evaluations of the reproducibility of efficacious effects associated with some transplanted cells.
The Spotlight takes a global look at current and changing regulatory policy for stem cell medical research. Experts review and evaluate recent policy developments for government agencies in the U.S., Europe, Japan, Canada and other countries.
On June 27, the Spotlight series will feature an online panel discussion of the topic. Panelists include leaders in companies and agencies that support development of cell therapeutics. James L. Sherley, M.D., Ph.D., Director of Asymmetrex, is one of the invited panelists. Sherley adds a perspective that has been missing from recent panels of this type on many different aspects of cell therapy, in particular cell therapy regulatory policy.
An important role for medical research regulatory policy is insuring the quality of evaluated prospective medicines. In the case of regenerative stem cell medicine, meeting this charge was not fully possible previously. No suitable methods existed for quality control evaluation of the essential stem cells in treatment samples. Asymmetrex now markets a technology for this purpose. On the panel, Sherley will address how the availability of a means for determining treatment stem cell quality and dose may impact future developments in stem cell medical research regulatory policies.
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 quality and dose of tissue stem cell preparations (the “AlphaSTEM Test”) for use in stem cell transplantation therapies and in pre-clinical assays for drug safety.