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Perspectives: Nature editorial on stem cell oversight & clinics gets it right

July 7, 2016 / Professor Paul Knoepfler, Ph.D.

The journal Nature published an excellent editorial earlier this week on stem cell oversight and stem cell clinics. The piece, entitled ” FDA should stand firm on stem-cell treatments. US regulators must regain the upper hand in the approval system” struck just the right balance. It correctly supported the FDA’s data-centered approach to stem cell oversight and […]

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Do Patients Have a Fundamental Right to Choice?

May 14, 2015 / Professor Paul Knoepfler, Ph.D. / 9 Comments

What is the “proper” amount of freedom of choice for patients in medicine? What if the treatments in question are experimental and come with their own baggage of associated risks, personal costs, and potential costs to society? More broadly, do patients have a fundamental right to medical choice? These questions seem particularly appropriate today on

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FDA & Japanese Health Ministry (厚生労働省) To Develop iPS cell clinical rules

July 12, 2013 / Professor Paul Knoepfler, Ph.D. / 1 Comment

In a rare sign of stem cell international regulatory unity, the Japanese Health Ministry (厚生労働省) and the US FDA have agreed to develop a joint, unified regulatory framework for clinical studies of human iPS cells for use in treating retinal diseases. Presumably the rules would also guide clinical use of iPS cells to treat other

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Why the extreme religious right are turning against iPS cells

May 9, 2013 / Professor Paul Knoepfler, Ph.D. / 5 Comments

Dr.-Oz-told-Oprah-and-Michael-J.-Fox-religious-right

There was a time, not so long ago, when the religious right hailed the discovery of induced pluripotent stem (iPS) cells. Headlines blared from the extreme right on the Internet such as, “Embryonic stem cells obsolete”. Even the same kind of thing, saying, “The stem cell debate is dead”. You see opponents of embryonic stem

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Truly frightening questions for stem cell field on Halloween

October 31, 2012 / Professor Paul Knoepfler, Ph.D. / 2 Comments

The Stem Cell Meeting on the Mesa is going on in my former hometown of La Jolla, Ca on Halloween. I wish I could have been there, but I’m too swamped with a lot of stuff right now including teaching. If I was there, I’d be asking questions including, I hope, tough ones. Here are

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As stem cell industry explodes, can a static FDA keep up?

September 19, 2012 / Professor Paul Knoepfler, Ph.D. / 8 Comments

There are legitimate arguments about the degree to which the FDA should regulate stem cell clinics and the point-of-care, for-profit stem cell industry. I’ve held debates about that on my blog with argument on both sides including a very valuable debate between Dr. Chris Centeno and Doug Sipp. However, increasingly it is looking like the

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Great interview with Lee Buckler on stem cell industry, regulatory issues, and Celltex

July 3, 2012 / Professor Paul Knoepfler, Ph.D. / 8 Comments

As I’ve been writing this blog for the last couple years it has served as a catalyst for me to meet dozens of really interesting people. One such person is Lee Buckler, a true stem cell industry guru. Given all the complex events of late in the stem cell field, I asked Lee if he

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Trying to understand the Catholic ban on the Komen Charity

July 31, 2011 / Professor Paul Knoepfler, Ph.D. / 1 Comment

The Susan G. Komen Foundation is an awesome organization. It has raised nearly $2 billion dollars in less than 2 decades for breast cancer research. It also has a variety of educational programs. This is an organization that has likely saved hundreds of women’s lives and I think will save thousands of lives through its

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Q&A with Kyle Cetrulo of The Perinatal Stem Cell Society on the FDA, state laws, & more

May 15, 2024 / Professor Paul Knoepfler, Ph.D. / 5 Comments

Kyle Cetrulo, Perinatal Stem Cell Society

I was interested to see that an organization called The Perinatal Stem Cell Society seems to have been upbeat about the new Utah stem cell law. That law sets up a likely conflict with the FDA and federal law over stem cells. In a nutshell, Utah now says you can sell non-FDA-approved stem cells in

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Weekend reads: stem cells, CRISPR, glioma, stroke, RTT & more

September 29, 2019 / Professor Paul Knoepfler, Ph.D. / 8 Comments

Every so often I realize I’ve accumulated a bunch of tabs on my browsers of things I need to dive into as time permits, which sometimes translates into a collection of recommended reads here on The Niche. Here are some recommended recent reads in the stem cell/regenerative medicine field and childhood cancer space. It includes

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