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Review of ExoFlo paper used to push Direct Biologics IND inside FDA finds red flags

ExoFlo from Direct Biologics

I wrote recently about how political pressure on FDA Commissioner Stephen Hahn in 2020 may have helped the Texas firm Direct Biologics move their product ExoFlo forward inside the agency. Today I analyze the ExoFlo Phase I clinical trial paper used in that push on Hahn to get the firm the IND for a Phase II […]

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Fact-checking exosome therapy: costs, risks, & lack of data

model of an exosome, exosome therapy

Exosome therapy is a still-experimental cell therapy approach aimed at treating specific diseases using secretions from cells. It’s novel since most attention on cell therapies has been given to using the actual cells themselves. In addition, this approach is a newer idea than using cells as the drug to treat diseases. Interestingly, the term “cell

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Regenerative reads: 3 CRISPR babies, FDA warning, diabetes, pubs

CRISPR-baby

If you celebrate the Thanksgiving holiday I hope you had a nice one and, right before it started a new article popped on the scene about the CRISPR babies. Before we discuss those three gene-edited people, who are now growing up into little kids, we hit a milestone on our YouTube Stem Cell Channel with

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$7.8 million verdict in stem cell clinics case against Neil Riordan

RMI

Those who follow the stem cell field might be familiar with stem cell clinic operator Neil Riordan. According to a recent press release and some news reports, Riordan just had some bad news in court related to a stem cell clinic in the U.S. Stem cell clinic lawsuit As background, why do those running stem

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Weekly reads: Stem cells for vision loss & recommended pubs

stem cells for vision loss ribeiro et al

I’m going to start off today’s recommended reads post with some stem cells for vision developments. I had some fun the last 2 weeks as people sent in their entries for our $100 stem cell picture contest. I’ll announce the winner this week. It’s going to be hard to choose given the great entries. Stem

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New lab-grown blastoids are strikingly similar to human embryos

blastoids nature paper figure 2

A new word has been added to the lexicon of human stem cell research – blastoids, aka “blastocyst-like structures.” Unlike the familiar three-layered embryo that emerges during the third week of prenatal development, the earlier blastocyst resembles a fluid-filled soccer ball, with a smear of cells on the interior face destined to develop into the

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Fact-Checking Panama stem cell institute: cost, safety, efficacy, docs

Somehow time has flown by so that I’ve been around for ages in the stem cell universe and some unproven stem cell clinic type firms, like the well-known Panama stem cell clinic that sells autism “treatments”, are also long-timers. It’s been an odd parallel existence for more than a decade. Today’s post is focused on

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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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Can Gene-Edited Stem Cells Treat Cystic Fibrosis?

human-IPS-cells-made-in-Knoeplfer-lab-stained-for-TRA-160

Drugs that restore the shape of the errant protein behind cystic fibrosis (CF) have, over the past eight years, helped the majority of patients, who have certain mutations. Gene-corrected stem cells might offer a “mutation agnostic” option to CF. CF results from a glitch in a glycoprotein with the unwieldy name “cystic fibrosis transmembrane conductance

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