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A Stem Cell Count Would Have Made It Better

Inaugural Entry #1
Wednesday, September 8, 2021

As the inaugural entry for Asymmetrex’s new informational “A Stem Cell Count Would Have Made It Better,” page, we consider the July 27, Stem Cells Translational Medicine report of Dr. Beata Świątkowska-Flis and co-authors (https://stemcellsjournals.onlinelibrary.wiley.com/doi/epdf/10.1002/sctm.21-0027). Their report was also featured online by news platforms like Medical Xpress (https://medicalxpress.com/news/2021-07-stem-cell-treatments-alleviate-muscular.html). The report describes the authors’ observations of improvements in the signs and symptoms of patients with several different muscular dystrophies after treatment with expanded “umbilical cord-derived mesenchymal stem cells (UC-MSCs).” The authors do not use stem cell-specific dosage for their treatments. Here, we consider how a stem cell count would have made their study better.

The authors follow the common practice of using their expanded UC-MSC preparations as if they were homogeneous stem cells. They are not; and the stem cell-specific fraction varies with the extent of culture, characteristically decreasing with passage number. In addition, though it is not possible to discern from the report if patients in the study were treated with different lots of UC-MSCs (e.g., produced from umbilical cords from different donors), if they were, then their stem cell-specific dose would vary.

Because a stem cell-specific count was not used, the study could not detect treatment outcomes related to tissue stem cells versus the other two main types of cells present in treatment preparations. Those are non-stem committed progenitor cells and terminally-arrested cells. Equally important, the study missed the opportunity for greater statistical power to detect stem cell-specific treatment effects. Simply put, many of the treated patients showed poorer responses or no responses. If these non-responsive patients were found to have on average a lower specific dosage of any of the three types of cells injected, and of stem cells in particular, such information would be a major advance to better understanding the basis for the observed differences in treatment outcomes. Moreover, it would better inform the design and development of the next generation of stem cell medicine clinical trials that the authors envision. A stem cell count would have made it better. Visit Asymmetrex’s Stem Cell Counting Center to learn more.

We invited corresponding author, Dr. Beata Świątkowska-Flis, to consider this review and provide a response from the authors. They were non-responders, too.

Next review: September 22, Gamida Cell’s Omidubicel Trial

We are pleased to share in the discussion comments received from readers:

  • I totally agree with your comments. This seems to be the same process seen with most new discoveries. The information is very new and everyone wants to get that information on the new process or material as quickly as possible. To satisfy that desire the early users are anxious to get articles and presentations out there often regardless of appropriate study protocols for the use of the new material in order to be recognized as the first users and therefore the "experts" in the new process. And as you pointed out these flawed studies, although quickly and easily accomplished, provide either inadequate information or worse, misinformation. In the long run it seems that this delays acceptance of the new item by the more cautious as well as by regulatory agencies, requires better studies to be done that should have been done in the first place and probably damages the reputation of those who publish or present these poorly designed studies. Thank you for pointing this out but I wonder when and if we will learn that taking a little more time with well designed studies will actually get the new item in to general use faster?

    Jack Coleman, M.D. September 8

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