One size doesn’t fit all? FDA may soften some cell therapy regs

dr. peter marks fda, cell therapy

The Pink Sheet just broke the story that the FDA may change up its oversight of the cell therapy space. This possible shift could drop the oversight bar somewhat for certain products. Most likely it’d be those with lower anticipated risks. The Pink Sheet piece by Sue Sutter is titled US FDA To Explore New Regulatory Pathways …

One size doesn’t fit all? FDA may soften some cell therapy regs Read More »

MO Rep Patricia Derges already indicted for alleged stem cell scheme, now sued by patient

patricia derges indictment for fake stem cells sm

The news just keeps getting worse for Missouri state lawmaker Patricia Derges, who was indicted last year by the feds for an alleged stem cell scheme. She is now also being sued by a former patient. Derges, who is not a physician but rather an assistant physician, was providing supposed stem cell or related biological …

MO Rep Patricia Derges already indicted for alleged stem cell scheme, now sued by patient Read More »

The Niche foreign language outreach program: 2.5 million reads

stem cells

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 »

Weekly reads: our new brain tumor paper, levitation, dear doctor, Japan, more

brain tumor, H3.3 K27M, ASCL1

There’s nothing quite like getting a new paper out as a scientist running a research lab so this week we can celebrate our new pediatric brain tumor study. I’ll start the weekly reads with that paper. Of course, getting new grants is amazing too but there’s more of a feel of completion after a paper …

Weekly reads: our new brain tumor paper, levitation, dear doctor, Japan, more Read More »

Thoughts on death of stem cell clinic leader Dr. Mark Berman

Elliot-Lander-and-Mark-berman-300x2331

Over the past dozen years as I’ve written about stem cell clinics here on The Niche I’ve gotten to know many of those running the clinics including Dr. Mark Berman of Beverly Hills. It was therefore kind of a shock to learn that Berman died of last month. Michael Hiltzik of the LA Times reported …

Thoughts on death of stem cell clinic leader Dr. Mark Berman Read More »

Overplaying N=1 in the stem cell therapy world

stem cell therapy, star patient

The regular emails and phone calls I get from patients asking questions about stem cell therapy are a powerful reminder of the fact that research in our field can be very personal. Sometimes individuals who receive experimental stem cell therapy (or other cell therapies) and seem to have a positive outcome can end up becoming …

Overplaying N=1 in the stem cell therapy world Read More »

Weekly reads: neural stem cells, CRISPR brain, Vertex, cytoplasm surprise

neural stem cells

Some people consider the brain to be equivalent to a living computer and in that sense it’s too bad that computers don’t have the equal of neural stem cells to help them fix themselves. Is the internet one big neural network-like web? There was a quake in the stem cell internet as CIRM’s main website …

Weekly reads: neural stem cells, CRISPR brain, Vertex, cytoplasm surprise Read More »

Nature paper claims young CSF fights brain aging in mice

old mice get young CSF

A new Nature paper argues that young CSF fights brain aging. Young CSF vs. young blood CSF is the cerebrospinal fluid that surrounds the brain, including those of young mice. The claim is that when young CSF is injected into the brain/CNS cavity of old mice, it makes the aged brains seem younger. And function …

Nature paper claims young CSF fights brain aging in mice Read More »

Google ads policy change to allow unproven cell & gene therapy educational material

Google ads policy, stem cell therapies

A planned change to the Google ads policy will allow some ads for unproven cell and gene therapies. This shift, allowing educational ads, was just announced. I have a few concerns about this change that will start in July. Google ads policy and stem cells This move seems to be a refinement of their “ad ban” policy …

Google ads policy change to allow unproven cell & gene therapy educational material Read More »

Weekly reads: Vertex hold, new type of cell division in fish, CAR-T

zebrafish cell division

I remember the first time I ever witnessed human cell division first hand and it was really excitement. I was working as a part-time tech in the Lane Lab at UC San Diego School of Medicine. We studied heart disease and grew human umbilical cord endothelial cell cultures. It was striking to see a plate …

Weekly reads: Vertex hold, new type of cell division in fish, CAR-T Read More »