September 24, 2020

The Niche

Knoepfler lab stem cell blog

Recommended reads: FDA warning, COVID updates, stem cell pubs

Tao et al Stem Cell Reports 2020 Fig. 1c
Tao et al Stem Cell Reports 2020 Fig. 1c. Legend, “IF staining of β-catenin, OCT4, SOX2, and NANOG at 48 h after β-catenin knockdown compared with mock control ESCs. Scale bar, 25μm.”

What’s been going on in the stem cell and regenerative medicine field over the past week and what are some worthwhile things to read? Today’s post has recommended recent reads from the scientific literature and the media.

I’ve also got our weekly stem cell/regenerative medicine quiz question and the answer to last week’s. You can check out last week’s recommended reads here, which has last week’s quiz question.

Toward the bottom of the post there’s also a “blast from the past” link to a piece I did a decade ago on the travails of publishing and peer review.

How much has changed? It doesn’t seem like some of the core problems have really gotten any better.

Predictive Biotech gets FDA warning letter

Predictive Biotech received an FDA warning letter this week, sparked for a number of reasons it seems, but primarily related to their umbilical cord derived product CoreCyte. The agency defines CoreCyte as an unapproved and misbranded drug product:

“CoreCyteTM is an unapproved new drug under section 505 of the FD&C Act, 21 U.S.C. § 355.  Furthermore, this product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. § 352.”

The FDA also raised issues about the marketing of the product.

Predictive popped up on my radar screen last year including in part related to a blog post by Derek Lowe that stirred things up. Also a few months back I had a news blurb about Predictive as well with more bad news for the firm: “Predictive Technology Group ($PRED) had its stock suspended for its COVID19 testing claims. Predictive’s stem cell claims stirred controversy last year.”

Studies in mice give clues to combatting changes in aging muscle stem cells

COVID-19 updates

New pub on stem cells for COVID

Signal Transduction and Targeted Therapy, Human umbilical cord-derived mesenchymal stem cell therapy in patients with COVID-19: a phase 1 clinical trialThe paper is not conclusive as to whether there is any benefit, but argues for a relative solid safety profile.

Children with COVID could be hard to spot at school

From Nature, Coronavirus research updates: Why infected primary-school pupils could be hard to spot

IPS cell heart study OK’d in Japan

Keio University gets OK for iPS-based heart cell transplant plan. A key part of the article: “The research will be carried out by a team led by Prof. Keiichi Fukuda for three people between 20 and 74 suffering from dilated cardiomyopathy, which lowers the heart’s power to pump blood. The first transplant will be conducted by the end of this year at the earliest.”

Note that a different team at Osaka University got approval for the first IPS cell-based heart procedure two years ago and did the first procedure using a product from IPS cells on a patient last year.

Stem Cell Pubs

Blast from the past

I Hate Your Paper: Dr. No and the Editors that are ruining peer review

A decade ago this post sparked a lot of discussion and it seems many of the exact issues are in play now.

This week’s stem cell quiz question and the answer to last week’s question

This week’s question

What is a blastema and why is it so important in one area of potential regenerative medicine?

Shinya Yamanaka, history of iPS cells
Screenshot of Shinya Yamanaka slide on the history of iPS cells.

Last week’s answer

Last week I asked what scientist at the Fred Hutch in a way helped lay a foundation for Shinya Yamanaka’s development of reprogramming to make iPS cells. The answer is Hal Weintraub, whose pioneering work on MyoD and muscle differentiation demonstrated the power of defined factors to dictate cell fate.

See Yamanaka’s Nobel lecture, which has a nod to Weintraub. You can see a screenshot from one key slide from Dr. Yamanaka above, where he gives an overview of what led up to IPS cells. Dr. Yamanaka is not only a great scientist, but also a class act who honors other scientists and scientific history.

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