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

March 17, 2022 / Professor Paul Knoepfler, Ph.D. / Leave a Comment

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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Weekly reads: aging, CRISPR delivery, hair, oocytes, paralysis

January 23, 2022 / Professor Paul Knoepfler, Ph.D. / Leave a Comment

The big news of the week was the launch of Altos labs and their ambitious plan to tackle aging through cell therapies. Altos has recruited a large number of top cell biologists away from academia. That team plus top biotech execs and a $3B war chest make Altos one to watch in coming years. I

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

November 28, 2021 / Professor Paul Knoepfler, Ph.D. / 3 Comments

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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Weekly reads: New FDA guidance, brains, MSCs, senescence

October 10, 2021 / Professor Paul Knoepfler, Ph.D. / 1 Comment

This week marked the release of new draft FDA guidance on cell and gene therapies. Is the FDA kind of like the guidance counselor at school or more like the principal? It probably depends on many factors. I also find it funny how pretty much everyone in academia and biotech industry works to be compliant

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The Niche weekend reads: Editas mess, The Niche updates, papers

October 3, 2021 / Professor Paul Knoepfler, Ph.D. / Leave a Comment

The news of the week relates to an interim clinical trial report from gene-editing firm Editas on its CRISPR trial for a form of vision loss. On to that in a minute. What have you been reading the past week? Below, I include our weekly list of recommended reads. However, first I wanted to give

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Weekly reads: Orchard punts on life-saving SCID trial, cardioids with cavities, more

May 23, 2021 / Professor Paul Knoepfler, Ph.D. / 5 Comments

Sometimes things in the stem cell world get complicated and this week is no exception with news of Orchard Therapeutics dropping a seemingly life-saving clinical trial. There are hundreds of kids who could possibly benefit. Rotten apple decision from Orchard Therapeutics From David Jensen at California Stem Cell Report we have something of a scoop:

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Weekly reads: oncodevelopmental factors, iPSC cancer vaccine, more

May 9, 2021 / Professor Paul Knoepfler, Ph.D. / 1 Comment

One of my main research interests is in oncodevelopmental factors. These include factors that are important both for normal stem cell biology and development as well as driving cancer when misregulated. One example includes the MYC family of proto-oncogenes. When I was a postdoc I got especially interested in trying to understand the normal role

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Autologous vs allogeneic: all you need to know on therapy

March 22, 2021 / Professor Paul Knoepfler, Ph.D. / 4 Comments

There are many ways to classify different stem cells. These differences include yours versus someone else’s cells. Another distinct in a clinical sense is what we call an autologous vs allogeneic stem cell transplant. This post is focused on the difference between allogeneic (someone else’s cells) and autologous (your own) stem cell injections. As a

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Regenerative reads: brain organoids, Clinicaltrials.gov change

February 28, 2021 / Professor Paul Knoepfler, Ph.D. / 1 Comment

Sometimes change takes a very long time, but with brain organoids or advocating for better information for patients at Clinicaltrials.gov, after waiting you can see some interesting developments. These are two of the regenerative medicine stories of the week, along with some striking research papers. Clinicaltrials.gov Some of us have been advocating for improvements at

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