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Another FDA letter to a stem cell clinic supplier: what’s the agency’s long game?

November 25, 2019 / Professor Paul Knoepfler, Ph.D. / 10 Comments

The FDA just sent another untitled letter to a producer of a potentially non-compliant perinatal “stem cell” product that may be an unapproved drug. This follows past non-warning letters and/or inspection reports made public to Liveyon, R3 Stem Cell, Stemell, and others. RAPS has more on the story of the new letter here. This newest […]

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MUSE cells are in 4 Japanese stem cell trials despite doubts

November 17, 2019 / Professor Paul Knoepfler, Ph.D. / 16 Comments

Professor-Mari-Dezawa-talking-about-MUSE-cells-on-national-TV-in-Japan.-Screenshot.

The stem cell universe is populated by sometimes mysterious acronyms (see an image of a whole alphabet stem cell acronym soup), many of which refer to specific kinds of stem cells including one nebulous type called MUSE cells. MUSE cells clinical trials I’m not convinced that MUSE cells exist, but oddly there appear to be

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Whatever happened to the STAP cell scientists including Haruko Obokata?

November 14, 2019 / Professor Paul Knoepfler, Ph.D. / 3 Comments

Once upon a time this blog and major outlets around the world were regularly writing about a Japanese stem cell researcher named Haruko Obokata (小保方晴子). Whatever happened to Obokata and the other folks directly involved in STAP cell research? First, a bit of background because maybe still a few people never heard of STAP cells

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MD Stem Cells purported Right To Try program

November 3, 2019 / Professor Paul Knoepfler, Ph.D. / 15 Comments

I’ve been concerned about a stem cell group called MD Stem Cells for many years. Now it comes under more scrutiny from a new must-read piece by Donna Young over at S&P Global. Young’s article reports a puzzling, purported right-to-try (RTT) program that MD Stem Cells appears to working on with Richard Garr. Note that

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My B grade to Google on early test of its stem cell clinic ad ban

October 20, 2019 / Professor Paul Knoepfler, Ph.D. / Leave a Comment

As of October 1, Google was supposed to have banned ads for unproven stem cell clinics and products. This was according to their own new policy. How’s that going? How’s this new Google approach to unproven stem cell marketing working out in the real wild world of the web? To test it, I did over

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ViaCyte Q&A: CRISPR Tx quick progress, ongoing diabetes trial, & more

September 25, 2019 / Professor Paul Knoepfler, Ph.D. / 9 Comments

ViaCyte is one of the most exciting stem cell and regenerative medicine biotech companies so I like to try to check in with them regularly. Today’s post is my new interview with ViaCyte leader Paul Laikind on recent developments. We had a great chat about the science and how things are looking upbeat for the

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Journal erred on Panama clinic stem cell for autism paper

September 15, 2019 / Professor Paul Knoepfler, Ph.D. / 22 Comments

The-Stem-Cell-Institute-stem-cells-for-autism, Panama Stem Cell

Amongst all that is bouncing around within the stem cell clinic maelstrom out there, one thing stands out for me as the most troubling. I’m talking about for-profit experimentation on children, such as injection of kids with unproven stem cells for autism or cerebral palsy by unproven clinics. In my opinion it’s almost always going

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Google to block unproven stem cell clinic & gene therapy ads

September 6, 2019 / Professor Paul Knoepfler, Ph.D. / 19 Comments

Watch-out-for-unapproved-stem-cells-FDA-video-Google

The Washington Post broke the story this morning that Google has a new biomedical ad policy that may really shake things up for stem cell clinics. The search giant announced the new policy on its blog that will restrict advertisements for unproven stem cell clinics, cellular and gene therapies. This is great news. Google new

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Our dragon book gets a flaming thumbs up in Nature review

August 25, 2019 / Professor Paul Knoepfler, Ph.D. / 1 Comment

When you write a book like our new dragon book, as the first reviews of it start coming in you just never know what they’ll be like. When the person or outlet doing the review has a huge audience, the stakes are higher. How have the early reviews been for our new How to Build

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What is stromal vascular fraction or SVF?

July 21, 2019 / Professor Paul Knoepfler, Ph.D. / 26 Comments

When people discuss “fat stem cells” they usually mean “stromal vascular fraction” or SVF. While references to fat or adipose stem cells can sometimes mean non-SVF materials, these days adipose SVF gets the most attention. But, does anyone have a clear picture of this biologic? Fortunately, it’s starting to come more into focus in recent years

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