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Regenerative reads: brain organoids, Clinicaltrials.gov change

February 28, 2021 February 28, 2021 / By 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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FDA outlines potential crackdown on Clinicaltrials.gov offenders

September 23, 2018 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 11 Comments

Clinicaltrials.gov is a wonderful resource for its many users, whether a patient searching for a clinical trial to actually participate in or someone doing research as I have done, but it’s not perfect and some sponsors have been breaking the rules regarding its use. It’s a major problem in fact. Based on new draft guidance …

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

October 14, 2014 February 1, 2021 / By 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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Interview with Clinicaltrials.gov Director Deborah Zarin

September 24, 2014 March 6, 2021 / By Professor Paul Knoepfler, Ph.D. / 4 Comments

This post is the first in a series about the Clinicaltrials.gov website. This piece is an interview the Director, Dr. Deborah Zarin. I want to thank her for taking the time to answer my questions. Later, I will post Part 2 in which I discuss my concerns about the trend of for-profit stem cell clinic trials …

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US Stem Cell says it & 10 others face malpractice suits

May 12, 2023 May 12, 2023 / By Professor Paul Knoepfler, Ph.D. / 3 Comments

Unproven stem cell clinic firm US Stem Cell and many others are apparently facing potential malpractice lawsuits. How it came to light via US Stem itself is somewhat surprising. US Stem Cell and malpractice notice The news popped up in an SEC filing by US Stem Cell, which I wasn’t even sure was still active …

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Long telomeres link to disease suggests caution on anti-aging push

May 9, 2023 May 8, 2023 / By Professor Paul Knoepfler, Ph.D. / 5 Comments

Are long telomeres better than short ones? What about older folks lengthening their telomeres somewhat or stabilizing the length? Could this counter aging? As with many things, the story is far more complicated than we might hope. For background, telomeres are special structures protecting the ends of chromosomes. I remember as a young student that …

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Can stem cell therapy for back pain work?

May 3, 2023 May 3, 2023 / By Professor Paul Knoepfler, Ph.D. / 3 Comments

I often get asked about where things stand with stem cell therapy for back pain, which is the focus of today’s post. Back pain is a complex condition with many potential causes. New treatments are needed as existing approaches often don’t work that well. What about stem cells? Stem cell therapy or other cell therapy …

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Where Kimera Labs fits into sphere of exosome companies

March 16, 2023 March 16, 2023 / By Professor Paul Knoepfler, Ph.D. / 2 Comments

Today’s post takes a close look at the exosome manufacturer Kimera Labs in the context of the main exosome companies. What are exosomes? Exosomes are microscopic bubbles or vesicles produced by cells. Exosomes contain many cellular substances that are biologically active. Some of these materials may be helpful clinically, while others could pose risks. Clinical outcomes …

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WHYY oh WHYY: NPR puff piece on risky stem cell microneedling

March 14, 2023 March 24, 2023 / By Professor Paul Knoepfler, Ph.D. / 2 Comments

I usually associate NPR with solid journalism so I was scratching my head about a recent puff piece by WHYY on stem cell microneedling. Is this journalism or product promotion? The NPR piece by Maiken Scott doesn’t ask important questions. Scott received stem cell microneedling herself using a product from a company called AnteAGE. How …

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Heart stem cells trial mostly disappoints but is oversold

March 2, 2023 March 13, 2023 / By Professor Paul Knoepfler, Ph.D. / 6 Comments

Are there endogenous adult heart stem cells that are useful in cardiac disease or can stem cell infusions help ailing hearts? As to the first question, the adult heart does not appear to have meaningful numbers of true stem cells. Further, testing the idea of infusions of stem cells for heart disease has so far been giving …

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