Search Results for: clinicaltrials.gov

Regenerative reads: brain organoids, Clinicaltrials.gov change

brain organoids sm

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

Anderson-et-al-Clinicaltrials.gov_

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 Based on new draft guidance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

slickstem

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

clinicaltrials.gov_

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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Weekly reads: GIOSTAR stem cell clinic IND, cadaver marrow, NIH under Trump 2.0, tweets from a stem cell

Giostar

What happens if unproven stem cell clinic firms like GIOSTAR start getting okays from the FDA to do clinical trials? On the one hand, it could reflect a positive trend of stem cell clinic firms working with the FDA and toward compliance. Having more robust data. However, I worry about some of these types of

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Capricor seeks FDA approval of deramiocel for Duchenne based on encouraging data

Linda Marbán, Capricor

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

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

Stem cell supplements

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

Neuralink, BCI

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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Recommended reads: Stem cells in Japan, iPS cells for COVID & hearts, He Jiankui

fruit fly intestine, stem cells in Japan

How are things going with regenerative medicine and stem cells in Japan? It’s still an exciting time there, but I’ve noted a sense that it is a time of transition too in some ways. For example, government funding is perhaps less certain than in the past. Let’s start with a few articles on how the

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