Educational

What is an FDA warning letter & how should firms respond

FDA warning letter

Firms that are active in the biologics space face many possible challenges but the possibility of getting an FDA warning letter is one of the most intense. The goal of today’s post is to explain what an FDA warning letter is all about. This analysis includes what such a letter means and what steps come …

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What are blastoids, roles in biomedical research, & ethical considerations

blastoids nature paper figure 2

Blastoids are lab-grown models of human embryos that represent a relatively new area of developmental biology research. The goal of today’s post is to give you everything you need to know about this topic. What’s in this article What are blastoids? | How are blastoids made? |  Use in research | Blastoids challenges & Ethics …

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Fact-checking VSEL stem cells & supposed ‘VSEL treatment’

VSELs, vsel ratajczak paper issues

A few people in the stem cell field keep arguing that adult pluripotent stem cells exist, including so-called “very small embryonic-like stem cells” or VSEL stem cells. These days the supposed cells are called VSELs or V-cells too. Only a handful of researchers have ever been able to report finding and studying these cells. Others …

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Therapeutic misconception & the planned Duke Cryo-Cell cord clinic

Duke Cryo-Cell therapeutic misconception

One of the core problems in the world of unproven stem cell clinics is something called therapeutic misconception. I’ll talk more about that in a minute, but first, let me tell you what brought this to mind now. Surprisingly, the story starts at Duke University. A Duke cell therapy team and the biotech Cryo-Cell have big …

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Fact-checking Regenexx: reviews, data, & cost

Map of Regenexx stem cell locations. Screenshot of map from company website.

Stem cell clinic firms often come and go rather quickly, but a few like Regenexx have persisted and even become a brand name. I’ve been writing here on The Niche for more than eleven years about stem cell clinics. Regenexx has been around that whole time. Along with its founder Dr. Chris Centeno. Patients have …

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Autologous vs allogeneic: all you need to know on therapy

autologous vs allogeneic

There are many ways to classify different stem cells including yours versus someone else’s cells, or in a clinical sense what we call an autologous vs allogeneic stem cell transplant. This post is focused on the difference between allogeneic (someone else’s cells) and autologous (your own) stem cell injections. As a stem cell biologist I …

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Multipotent & totipotent vs pluripotent stem cells

Multipotent & totipotent vs pluripotent stem cells, very early human embryos totipotent stem cells

What’s the difference between multipotent stem cells, totipotent stem cells, and pluripotent stem cells? The goal of today’s post is to help you learn and be clear on the differences. What’s in this article Definition of stem cells |Totipotent vs pluripotent stem cells | Pluripotent stem cells | Multipotent stem cells | The best kind of stem …

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