Who is David Sinclair and why is he all over the media related to anti-aging efforts? This post is my effort to fact-check Sinclair’s statements in the context of the broader rejuvenation arena. In the process I also review his most recent paper from my view as a stem cell and cancer biologist interested in […]
Review of new David Sinclair paper, supplements & anti-aging glitz Read More »
Almost two years ago I publicly called on the FDA to freeze the unproven cord cell expanded access program (EAP) at the Duke Autism Center. Duke has been infusing kids with autism spectrum disorder (ASD) with unproven cord cells and requiring large payments for this. The cost was as much as $15,000. A halt and a
Why did Duke autism team halt its troubling pay-for-play program? Read More »
It’s funny how sometimes there are many new articles about one general topic like this week with heritable (and somatic) human CRISPR gene editing and related tech. There are clear reasons for optimism in the somatic arena given advancing trials. Germline editing remains highly questionable in my view even just technically. Then there are loads
Weekly reads: human CRISPR, MRT risks, private IRBs, skincare Read More »
Let’s start with a couple of new pieces on in vivo reprogramming. The idea here is to do something like making iPS cells but doing it inside organisms and not quite pushing cells all the way back to pluripotency. Just younger, healthier cells. Why do that? The goal is to achieve a kind of anti-aging
Weekly reads: reprogramming aging, astrocytes, cartilage, ChatGPT Read More »
The FDA seems oddly slow in oversight of unproven stem cell clinic-related firms like one here in California called Invitrx Therapeutics. I’ve written before about Invitrx, but interactions between them and the FDA have continued including a new warning letter. It’s become a puzzling situation. More broadly, the FDA has done relatively little in the past
3rd Invitrx warning highlights FDA oversight weakness Read More »
I started The Screamers a few years back as a biomedical science hype award. It’s kind of in the spirit of an Ig Noble Prize in the sense of an alternative “award”, but in this case for hype. In 2020, sadly the FDA Commissioner at the time Stephen Hahn won The Screamers award for a
2022 The Screamers Science Hype Award goes to The BBC 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 »
Patients regularly reach out and ask me about something called HSCT. “What is HSCT?” and is it proven as a therapy? Often the patients asking about this have multiple sclerosis (MS) or some other autoimmune disease. I’m not a physician so I can’t give medical advice, but as a stem cell biologist here at UC
What is HSCT & its possible roles in MS treatment? Read More »
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
What is an FDA warning letter & how should firms respond Read More »
There was a time when The Niche was just about the only stem cell blog or even stem cell-dedicated website more generally across the globe. I realized early on that I needed to reach people who don’t speak English or for whom English is not their first language. This goal was crucial for effective educational
The Niche foreign language outreach program: 2.5 million reads Read More »