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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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Weekly reads: NAM dubs 3 stem cell researchers, kick the 2 buckets, stem cell homing

Sally Temple, stem cell researchers

The National Academy of Medicine elected a cohort of new members including three stem cell researchers. It’s great to see our field and these great scientists get recognition. The new NAM stem cell researchers include Sally Temple, Connie Eaves, and Tippie MacKenzie. Here’s a little bit about each of them. Dr. Temple is a stem cell biologist

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Weekly reads: chimera cat vs. chimeric rat, cheap sequencing, more

Venus, cat chimera

When you are a stem cell biologist and especially if you do a blog, you sometimes run across very strange things like a chimera cat. In this case, I stumbled on the whole topic of chimeric cats because I was searching for info on chimeric rats on Google. Of course, I was. It’s kind of

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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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Review of cord banker Viacord: dubious autism claims & other concerns

Viacord is one of the most well known firms in the for-profit cord blood banking industry. Today’s post is a review of the firm. I see concrete reasons for concern. What is Viacord? | Dubious autism claims | Viacord cost | Overall Review | References What is Viacord? As a cord blood banking firm, Viacord freezes

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Is unproven stem cell therapy covered by insurance?

Does insurance cover stem cell therapy? Even at clinics? What about coverage from employers?

A common question I hear from readers of The Niche is some version of, “Is stem cell therapy covered by insurance?” Sometimes they also ask about Medicare coverage. To be clear, I’m talking about unproven stem cell “therapies” here. The type clinics sell. It’s not FDA approved so generally insurance companies and Medicare will not

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Histone code series: H3K27me3 & H3K27ac functions & roles in diseases like DIPG

ASCL1 in K27M tumors, H3K27me3 loss

Histone proteins such as histone H3 are often popping up in science writing and news sometimes includes specific modified forms of H3 including one that we scientists call H3K27me3. What is in this article What is H3K27me3? | The histone code | H3K27ac and H3K27me3 function | H3K27 and human disease | References The goal of today’s post

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ViaCyte purchase puts Vertex in driver’s seat on stem cells for diabetes

Doug Melton, Vertex, ViaCyte

When I’m asked about the most promising areas of stem cell clinical research, cell therapy for type I diabetes is near the top including work by a biotech called ViaCyte. Other firms are in the mix too, boosting the overall odds of success in the coming decade. It’s really that promising even though there are

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Weekly reads: freeze-dried cloning, FDA signals, stem cell escapees

Human-cloning

Cloning is one of those topics that both fascinates and kind of scares people, especially the idea of duplicating people. I regularly cover the topic here on The Niche because stem cell technologies are involved. Also, one form of the process sometimes called “therapeutic cloning” involves embryonic stem cells. Duplicating mammals has now long been

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Giostar stem cell clinic chain review, red flags, & lawsuit

Giostar

Some unproven stem cell clinics like one called Giostar have multiple locations sprouting up. To me the concern with that spreading is the potential of multiplying risks to consumers. It can be hard to get a clear take on what these clinics are doing too. What’s in this article What is Giostar? | Giostar review |

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