Search Results for: stem cell therapy

Weekly reads: Scott Gottlieb v. RFK Jr., DNA typewriters, Arnold Caplan

Peter-Marks-Scott-Gottlieb-FDA

Remember former Trump’s FDA Commissioner Scott Gottlieb? Gottlieb’s back in the news in an interesting way related to the upcoming second Trump administration. I just wrote about what to expect from new FDA Commissioner nominee Marty Makary. In that piece, I noted that Scott Gottlieb first came to lead the FDA after a record of

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Weekly reads: Xist & autoimmune disease in women, Crohn’s disease, dumb headline of the week

Xist ,auto immune disease

Readers of The Niche have asked me many questions about stem cells for autoimmune disease but the puzzle of why women get these conditions more often than men hasn’t come up before here. For instance, why is MS so much more common in women than men? It’s remained somewhat of a mystery over the years.

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Weekly reads: Vertex & CRISPR Therapeutics, Arnold Caplan death, MS genetics

CRISPR Therapeutics

The biotechs Vertex and CRISPR Therapeutics have an interesting relationship as biotechs. They are partners are multiple levels but also are very different as companies including in size. There’s been a key development in one of their partnerships. Before we jump into that, please check out the video version of my 20 stem cell and

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Review of Docere Clinics run by Harry Adelson including total-body injections

Amy Killen, Docere Clinic

In today’s post, I reviewed a stem cell clinic firm called Docere Clinics. In my opinion, there are some concerning issues here and reasons for caution. One type of procedure at Docere is particularly surprising and raises risks in my view. What is Docere Clinics? | What kind of stem cells does Docere use? | What they

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Weekly reads: BioCardia, HeLa suit, illegal bio lab in CA

mesenchymal cells

A days ago the news came about Mesoblast not getting FDA approval for its MSC product for GvHD. The MSC area has had a rough few years with various clinical trials including for COVID. The “stem cells for heart disease” arena has also had a tough time. Here’s more news along these lines: BioCardia pauses enrollment in PhIII trial

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Weekly reads: NurOwn, key gene screen, MS, Croce mess

Nurown BrainStorm

I get a lot of questions about stem cells for ALS and more recently people have been specifically interested in NurOwn from BrainStorm Cell Therapeutics. Recently, the FDA denied BrainStorm’s request for a BLA for NurOwn. The company felt its Phase III trial was encouraging. It sounds like they will move forward with a follow-up

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FDA leader Stephen Hahn was pressured to aid Texas firm Direct Biologics

Former FDA Commissioner Stephen Hahn.

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

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Recommended reads: Dux, 3D printed ear brings Vacanti mouse to mind, AMD, more

Vacanti Mouse

Eight years ago two new Nature papers broke on the scene reporting supposed STAP cells with one of the senior authors, Charles Vacanti of Harvard, most well known previously for making the so-called “Vacanti mouse” along with his brother Joseph. The Vacanti mouse had a bioengineered human ear growing on its back. While STAP cells

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