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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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FDA outlines potential crackdown on Clinicaltrials.gov offenders

September 23, 2018 / 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 Based on new draft guidance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 / 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 / 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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Capricor seeks FDA approval of deramiocel for Duchenne based on encouraging data

November 8, 2024 / Professor Paul Knoepfler, Ph.D. / Leave a Comment

The cell therapy biotech Capricor recently released new data from their Duchenne Muscular Dystrophy (DMD) trial work. The data have generated excitement in the patient advocacy community. The stock has skyrocketed. How exciting are these new data? CEO Linda Marbán is quite upbeat and I think it’s justified. The firm is now seeking FDA approval

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FDA’s CBER fires off 3 more warning letters on cellular biologics for a total of 12 in 2024

October 29, 2024 / Professor Paul Knoepfler, Ph.D. / Leave a Comment

Something seems to have dramatically changed with the FDA at its Center for Biologics Evaluation and Research or CBER. Did they start handing out free Red Bull by the case? So many recent FDA warnings on cell and tissue biologics CBER is the part of the FDA that regulates regenerative medicine products like stem cells,

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New review of stem cell supplements and pills

September 18, 2024 / Professor Paul Knoepfler, Ph.D. / 5 Comments

Today’s post is a review and fact-check of stem cell supplements. This is the second time I have looked at the state of stem cell supplements. If anything, it seems things have gotten more complicated and problematic in the last two to three years. Supplements | Stem cell supplements claims | Supplement ads and products | Visiclear,

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Neuralink on the brain: another person gets implant

August 8, 2024 / Professor Paul Knoepfler, Ph.D. / 3 Comments

Neuralink has had a rollercoaster ride in the last few years with many ups and downs. They just recently deployed a brain implant into a second clinical trial participant. So it’s a good time to update where things stand. This more general area of science is often called brain-computer interface (BCI) research. The implants are

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