The first time I heard CAR-T cells referred to as a regenerative medicine it made me stop and think. Are CAR-T therapies really a type of regenerative medicine? Generally, CAR-T cells are a designer immune cell therapy. They work by killing cancer cells and that’s what came to mind to me. I don’t tend to […]
What are CAR-T cells & are they regenerative medicine? Read More »
It’s been mostly a downbeat week on the stem cell news front including a deep revisit by Reuters to the Piero Anversa case that has new revelations. It’s ugly stuff involving other folks too. We’ll start on the iPS cell front, where a trial participant had a teratoma. I’ve had a long-standing interest in the
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 »
Dr. Paolo Macchiarini exemplifies how things can change quickly in the stem cell world and go from sky highs to deep lows. Stem cell rollercoasters Over the years, a few academic stem cell researchers as well as some operators in the unproven clinic sphere have had dizzying ups and downs. There’s John Kosolcharoen. His company
Paolo Macchiarini guilty in criminal stem cell case but does a Houdini again 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 »
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 »
If there’s one area of biologics where the FDA has been consistently busy lately it’s the perinatal cell therapy space. The agency has made it clear in the last year that allogeneic birth-related cell products are often drugs requiring premarket approval. This has mainly manifested at a practical enforcement level. We’ve seen actions taken in
End of FDA “grace period” impacted perinatal cell therapy biotechs Read More »
This has been one of those weeks where I spent some time thinking about taking risks in science. How much risk one should take? Risks can come in many forms. It could be at the core level at the bench doing specific experiments and not others. There’s risk in clinical trials, and even in advocacy. Sometimes
Weekly science reads: Macchiarini trial, somites, CRISPR babies Read More »
Today’s post lists the best stem cell blogs and more generally the top biology blogs as well as websites. Making lists of “the best” of anything is fun yet it can be tricky. However, I feel that it can also serve a purpose as a resource. You might also enjoy these other “top” lists I’ve
22 best biology & stem cell blogs for 2022 Read More »
In trying to figure out how unproven stem cell clinics get so many customers, I’ve found that these firms can in part thank Google. I recently wrote a guest piece on STAT News about this problem and called on Google to fix it. However, just this week I stumbled on another case of Google search
Google gets it dangerously wrong on stem cell side effects Read More »