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The backstory on my opinion piece in SF Chronicle critical of CIRM lobbying

June 19, 2016 / Professor Paul Knoepfler, Ph.D. / 3 Comments

Today an opinion piece that I wrote about CIRM was published in the San Francisco Chronicle. The unusual element here is that the article is critical of CIRM. More specifically I raised concerns about a recent political trend at CIRM under its new President Randy Mills lobbying for dramatically weaker stem cell regulatory oversight. The Chronicle piece was first posted […]

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Alliance for Regenerative Medicine (ARM) Opposes REGROW Act, Risks to Patients Cited

April 10, 2016 / Professor Paul Knoepfler, Ph.D. / 31 Comments

The biggest debate today in the stem cell world is over how much regulation is needed for new, investigational stem cell therapies that are not as yet approved. Sometimes it feels very lonely being out there publicly advocating for appropriately thorough regulation of stem cell therapies and at times I get a lot of heat for

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Bioheart on the edge in 2015?

May 6, 2015 / Professor Paul Knoepfler, Ph.D.

Stem cell biotech company Bioheart ($BHRT) has had a rough 2015 so far. Could this year be a decisive, negative tipping point for the company? It has a number of clinical trials going, but from my view things seem increasingly uncertain. An oddity amongst stem cell biotechs, Bioheart and its leadership have at times seemed to toy

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Interview with Bioheart CSO, Kristin Comella including on FDA

April 21, 2015 / Professor Paul Knoepfler, Ph.D. / 13 Comments

I invited the Chief Scientific Officer (CSO) of Bioheart, Kristin Comella, to do an interview after hearing some buzz that this could be a critical time for the company and that it might have been recently visited by the FDA. Note that Comella not just Bioheart CSO, but also the primary instructor for physician training in stem

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Clinicaltrials.gov Mission At Risk From Proliferating For-Profit Trials

October 14, 2014 / Professor Paul Knoepfler, Ph.D. / 3 Comments

It’s hard to even imagine the world of investigative medicine without the wonderful resource of Clinicaltrials.gov, the global hub for clinical trial listings. I recently interviewed the Director of Clinicaltrials.gov, Dr. Deborah Zarin here, which is a fascinating read. As great as Clinicaltrials.gov is as a resource, unfortunately it faces a new, rapidly growing problem that is a serious

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Blog readers investigate BioGatekeeper, the Yamanaka patent challenger

August 19, 2014 / Professor Paul Knoepfler, Ph.D. / 26 Comments

Who is trying, via the name BioGatekeeper, Inc., to nullify Yamanaka’s patent on cellular reprogramming to produce induced pluripotent stem (iPS) cells? The readers of this blog never cease to amaze me. What an informed, energetic, bright group. Within just days they may have collectively shed some light on an intriguing mystery in the stem cell field surrounding the

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Reflecting on Regenerative Medicine As A Brand

July 25, 2014 / Professor Paul Knoepfler, Ph.D. / 4 Comments

Stem cell-based Regenerative Medicine has huge power for good in the clinic and at the same time great potential for economic development. Those two things go hand in hand. As I argued in my stem cell book, biotech commercialization of stem cells is not a bad thing, but rather if it is done responsibly it

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23andMe and the FDA: Perspectives on Warning Letter

November 27, 2013 / Professor Paul Knoepfler, Ph.D. / 5 Comments

What’s the deal with this week’s FDA Warning Letter to 23andMe? First some background. I’m a researcher who studies stem and cancer cell genomics and epigenomics. I’m also a human being who has battled prostate cancer and is curious about my genome. With this background, I decided some time ago to take the plunge and experience what

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Interview with Regenerative Surgeon, Dr. Allan Wu

February 19, 2013 / Professor Paul Knoepfler, Ph.D.

Over the last few weeks, I have enjoyed talking with and interviewing Dr. Allan Wu, of The Morrow Institute on stem cell cosmetic procedures. I was impressed greatly by his talk at the World Stem Cell Summit last year. Dr. Wu is a fellowship trained Surgical Molecular Biologist with a background in Molecular Embryology and a board

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The Moriguchi iPS transplant fable: key lessons & where do we go from here

October 12, 2012 / Professor Paul Knoepfler, Ph.D. / 1 Comment

More and more evidence is accumulating that the alleged iPS cell transplantation in human patients by Dr. Hisashi Moriguchi was bunk. Nature today has a piece out today on the story providing more quotes about the case that suggest the whole thing was made up. Rather than re-hash all the details, in this post I’m going

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