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.”
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 trial. The 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
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
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?
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.