The poll I put up asking people their #1 top priority for FDA reform drew relatively big numbers of respondents. Speeding up clinical trials was clearly way out in front at #1. Expanding compassionate use was #2. These were followed by changing policy to no longer define lab-grown stem cells as drugs and FDA being […]
Results of FDA Reform Poll: speed up clinical trials & expand compassionate use Read More »
I wrote recently about how political pressure on FDA Commissioner Stephen Hahn in 2020 may have helped the Texas firm Direct Biologics move their product ExoFlo forward inside the agency. Today I analyze the ExoFlo Phase I clinical trial paper used in that push on Hahn to get the firm the IND for a Phase II
Review of ExoFlo paper used to push Direct Biologics IND inside FDA finds red flags Read More »
My lab is focused in part on chromatin states in stem cells and cancer including heterochromatin. In fact, my lab’s website is chromatin.com. Heterochromatin is dense, often inactive chromatin. By H&E staining and electron microscopy, heterochromatin looks dark compared to the rest of the nucleus, largely composed of euchromatin. Toward the end of my postdoc
Weekly reads: heterochromatin, H3.3, Mesoblast bump Read More »
It’s that time of year again when I grade my previous year’s predictions for the stem cell & regenerative medicine space. Overall, I did better than a typical year. I give the 2022 predictions an A- overall. This exercise can be kind of fun but also humbling. For example, I tend to be too optimistic
Grading my 2022 regenerative medicine predictions Read More »
An FDA FOIA dump of text messages of former Commissioner Stephen Hahn suggests that a Texas regenerative firm called Direct Biologics benefited from political pressure on him in mid-2020. Then he was asked again to help in early 2021. This was shortly before he resigned at the start of the Biden Administration. The push came from
FDA leader Stephen Hahn was pressured to aid Texas firm Direct Biologics Read More »
Some unproven stem cell clinics like one called Giostar have multiple locations sprouting up. To me the concern with that spreading is the potential of multiplying risks to consumers. It can be hard to get a clear take on what these clinics are doing too. What’s in this article What is Giostar? | Giostar review |
Giostar stem cell clinic chain review, red flags, & lawsuit Read More »
What if some legit place like The Mayo Clinic charged people just for the opportunity to talk to a doctor about possibly enrolling in a clinical trial? Imagine this kind of conversation. “Hey, Doc, I have this medical problem and heard you have a relevant clinical trial. Tell me about it.” Then the doctor fills
Mayo Clinic charges patients just to talk about clinical trials? Read More »
The last few years in the stem cell and regenerative medicine arena have been complicated in many ways. Variables like surging stem cell clinics and COVID have made predictions harder. Even so, trying to make predictions is useful and it’s fun to go over past year’s predictions. You can see my scorecard on my 2021
16 predictions for stem cells & regenerative medicine in 2022 Read More »
The past year was all over the place for the stem cell and regenerative medicine field. As you can see in my scoring of my 21 predictions for 2021, quite a few things were surprises in terms of what did and didn’t happen. Here’s an overview of the top stories of the year in our
Top stem cell stories of 2021: COVID, diabetes, human embryos, clinics in court Read More »
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
Therapeutic misconception & the planned Duke Cryo-Cell cord clinic Read More »