How Asymmetrex Counts Tissue Stem Cells:
“Kinetic Stem Cell Counting”
In the past, it has been impossible to count tissue stem cells like bone marrow blood stem cells and tissue mesenchymal stem cells. The counting problem persisted because no biomarkers could be found that identify tissue stem cells specifically. All available biomarkers also count other tissue cell types that greatly outnumber tissue stem cells in all their preparations. Whether in research, for drug evaluations, in biomanufacturing processes, or in treatments, tissue stem cells are a small fraction of the total cells. So, even with sensitive methods like flow cytometry, because the available biomarkers are not specific, tissue stem cell counting has been impossible.
Asymmetrex’s Tortoise TestTM and Rabbit CountTM technologies solve this problem by using kinetic stem cell counting. This computational method does not require biomarkers and does not require that the stem cells be altered in any way. Kinetic counting is based on measuring the rate at which other cells are produced by the special division of tissue stem cells. It counts tissue stem cells in their natural state.
Why Asymmetrex Counts Tissue Stem Cells: Quantitative Stem Cell Science and Medicine
Throughout the decades of cell science and medicine, quantitative approaches have been crucial for progress. There is a long and rich history of technical research and development to accurately count tissue cells for human tissue cell science and to quantify the dose of drugs for drug discovery, drug manufacturing, and medical treatments. In contrast, the history of stem cell science and stem cell medicine has been quite poor in this respect. No technologies have been available for counting tissue stem cells or knowing their dose for clinical development, biomanufacturing, or even for stem cell treatments, which include gene therapy and gene-editing therapy. Asymmetrex developed kinetic stem cell counting to address this unmet need. Kinetic stem cell counting from Asymmetrex moves stem cell science and stem cell medicine into a new quantitative era of accelerated progress, bringing better medicines to patients.
Now Asymmetrex Provides a Potency Test for Tissue Stem Cells
FDA 21CFR 600.3 definitions: “The word potency is interpreted to mean the specific ability or capacity of the product … to effect a given result.”
In many cases of tissue stem cell treatments and gene therapy treatments that target tissue stem cells (like hematopoietic stem cells), the desired result is the life-long replenishment of mature functional cells of the treated organs and tissues.
Potency assay attributes are:
- Indicate biological activities specific and relevant to the product.
- Measure activity of all ingredients considered necessary for activity.
- Indicate product stability.
The TORTOISE TestTM KSC counting analysis has each of these potency assay attributes for evaluating therapeutic tissue stem cell products:
- Indicating the specific dosage of therapeutic tissue stem cells.
- Measuring the treating stem cells’ specific rate of replenishment of mature functional tissue cells.
- Indicating the specific death rate and loss rate of tissue stem cells during culture expansion or storage.
Download an Example TORTOISE TestTM Potency Report today!