Stem-cell research continues to advance at a rapid pace, and standards are helping the field move forward.
By Tim Sprinkle
May 22, 2025
Nearly half a century after the discovery of stem cells, medical science is still finding new applications for them. Able to regenerate and develop into almost any type of cell in the body, they are uniquely flexible, offering potential treatments for a wide range of conditions, including blood cancers like leukemia and non-Hodgkin lymphoma, blood disorders such as sickle cell anemia, and even broken bones.
But stem cell research has faced limitations based on a lack of standardization. Because researchers today are using a variety of different methods to count stem cells in their samples, no one really knows how many they are working with at a given time, which can lead to difficulties.
“Presently, stem-cell science, stem cell medicine, and stem cell-related drug development are non-quantitative disciplines,” says Dr. James Sherley, MD, PhD, member of the committee on medical and surgical materials and devices (F04), and CEO of Asymmetrex LLC, which develops technologies for stem-cell counting applications. “They operate without knowing how many stem cells are in their samples. Blood stem cells, fat-derived stem cells, liver stem cells – all of those studies are going on without knowing how many stem cells are in the sample. So it follows that we are really underperforming and underachieving what we could be in those disciplines.”
Kinetic stem-cell counting is the method by which researchers can reach a differential stem-cell count for any type of stem cell, though the method is not yet widely used. Standardizing this method for determining the number of stem cells in a sample across the industry would make this work more quantitative and enable comparisons across studies and patient groups. This is one application of the new standard test method for cumulative population doubling analysis of the proliferation of vertebrate tissue cell preparations (F3716), developed by Sherley and the subcommittee on on cells and tissue engineered constructs for TEMPs (F04.43). The standard outlines methods for measuring and comparing how fast cells multiply. This is useful in tests and procedures performed in many different fields, including academic cell research; pharmaceutical and biopharmaceutical drug evaluations; cell and tissue biomanufacturing; regenerative medicine; toxicology; and the emerging cultured-food industry.
“Right now, when physicians conduct blood stem-cell transplants, those procedures can fail as much as 20% of the time because the transplanting physician didn't know that he or she didn't have enough stem cells in the sample,” Sherley says. “That happens a lot because we don't have accurate stem-cell counting and would be improved by having a way of knowing the actual stem cell-specific dose of tissues.”
Simply put, many of the methods commonly used today to measure cell multiplication properties are unreliable, making it difficult to compare results from one test to the next and limiting the reproducibility required by many scientific studies. F3716 is intended to provide the wide variety of industries that work with stem cells with a reliable test method for assessing and comparing the quality of cell-expansion processes, to streamline research and development around new medicines and cell-based therapies.
Now that it has been published, this test method will serve as the foundation for the next related standard, which will be focused on differential tissue stem-cell counting. But first, Sherley hopes the new standard becomes widely adopted.
“There are all these stem-cell proliferation studies going on, and to standardize that process is going to help produce better science,” he says. “In medicine, there's nothing worse than having two data sets that are not comparable. For instance, someone who's in a laboratory doing these self-proliferation rate studies not knowing whether they can compare what they did today to what they did last week or what they're going to do next week – and not knowing whether they can compare their rates to what someone else is reporting in the literature. Being able to know that the dose you give a patient here can compare to the dose that you give a patient in another treatment is important for science and a step toward making these fields more quantitative.”
Tim Sprinkle is a freelance writer based in Colorado Springs, CO. He has written for Yahoo, The Street, and other websites.
