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FDA news: warning letter pattern, cancer moonshot, CAR-T & gene-editing guidance

FDA-draft-guidance

The FDA has been busy with the COVID pandemic but it has many other things on its plate as well including cell therapies. Today I’m sharing some recent agency news and brief perspectives on it. FDA focus on clinic-related umbilical cord cell drug makers The agency warned an Idaho company that produces and sells umbilical …

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Tribute to pioneering stem cell scientist Meri Firpo

Tenneille Ludwig, Meri Firpo, and Rosario Isasi at a stem cell meeting (l-r).

Last week we lost Meri Firpo, a great scientist and dear friend in the stem cell community who touched many lives in positive ways. Today’s post is a tribute to Meri, who passed away from breast cancer. If you want to add a tribute please add a comment. Meri Firpo short bio Meri received her …

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Our new paper assessing trials of cell therapy for COVID-19

stem cells for covid 19 kim knoepfler 2021

After the COVID-19 pandemic started clinical trials quickly sprouted up to test various kinds of cell therapy for COVID-19 including stem cells. The most common rationale for this approach is to suppress damaging overactive immune responses. Trials of cell therapy for COVID-19 including stem cells I’ve written quite a lot about these cellular medicine and …

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Mesenchymal cells or MSCs: definition, clinical potential, challenges

mesenchymal cells, MSCs, mesenchymal stem cells

I confess that I’m old enough to remember when the acronym MSC stood unambiguously for “mesenchymal stem cells”, but should it refer to a broader term like “mesenchymal cells”? The field has moved in that direction. I think that’s the best way to go too and I’ll explain why. The goal of today’s post is …

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Head transplant update: fact check & perspectives

sergio canavero perhaps the leading advocate of head transplant technology

Is a head transplant actually going to be an option for extending life or changing what it means to be human? What about brain transplants? Let’s lump head and brain transplants together. Any possibility of this happening in coming decades? How close are we to that reality in 2022? In today’s post I give an …

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Recommended stem cell reads: retractions, aging, COVID, CRISPR soldiers

lu et al nature eye regeneration

This week we have some interesting new reading including both on the stem cell basic and translational fronts as well as on COVID-19 vaccines. COVID-19 vaccine considerations From Derek Lowe at In The Pipeline on COVID-19 vaccine expectations at Science Translational Medicine, Get Ready for False Side Effects. You can read my views on possible …

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CRISPR critters advancing science & agriculture

CRISPRd-goats-small

CRISPR applications in the real world The “breakthrough” gene-editing tool, CRISPR Cas9, has been utilized for various purposes since its popularization and commercialization in the early 2010s. While possible uses of gene editing in humans tend to get the most attention, the application of CRISPR-Cas9 also encompasses the animal world and the analysis of a …

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Overselling stem cells for COVID-19: WSJ article & UMN PR

EM-of-Novel-Coronavirus-SARS-CoV-2-that-causes-COVID-19

Many are  jumping on the bandwagon of trying stem cells for COVID-19 or testing other cellular therapies for the novel coronavirus disease, but there have been problems with either the rationales for the trials themselves or more often with how they portrayed. Sometimes there has even been outright hype. I’ve called this collective trend of …

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CRISPR often damages human embryo chromosomes

human-embryo-modification

Three new studies reported in preprints all show severe DNA damage to human embryos from CRISPR a surprisingly high percentage of the time including in some cases loss of heterozygosity (LOH). Anywhere from about a quarter to half of CRISPR’d embryos exhibited major genome damage. As readers of The Niche know, I never was a …

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Update on stem cells for COVID-19, Surgisphere scandal

Stem-cells-for-COVID-19-Maryland

The term Regenerative Medicine covers so much biomedical science these days including everything from just about any kind of cell therapy (not just stem cells) to CRISPR gene editing, and with the the COVID-19 pandemic, it seems this umbrella use of the term now includes potential treatment of viral illnesses. It can be hard to …

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