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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 Based on new draft guidance …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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3 cell therapy companies doing well: Vertex, Vericel, & Regeneron

November 15, 2023 November 15, 2023 / By Professor Paul Knoepfler, Ph.D. / 3 Comments

Cell therapy companies face many hurdles. I wrote recently about four cell therapy biotechs that have been really struggling. Blogging here at The Niche for more than a dozen years, I’ve seen many companies even go under. That’s bad news for the field, for patients, and for investors. Today I wanted to highlight some cell therapy …

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Weekly reads: stem cells for epilepsy from Neurona Therapeutics, diabetes, contagious cancer

October 8, 2023 October 7, 2023 / By Professor Paul Knoepfler, Ph.D. / 2 Comments

Neurona Therapeutics, stem cells for epilepsy

People often ask me what are the most promising stem cell therapies in development and new data suggest we should add stem cells for epilepsy to the list based on work by Neurona Therapeutics. I’ll start off the weekly recommended reads with this new mouse paper on cell therapy for epilepsy. Neurona Therapeutics: stem cells …

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Weekly reads: CRISPR sickle cell, Parkinson’s, pig-human chimera concerns

September 10, 2023 September 9, 2023 / By Professor Paul Knoepfler, Ph.D. / Leave a Comment

CRISPR gene editing has made rapid progress heading from bench to bedside. Perhaps the fastest has been its progress toward clinical use to combat sickle cell disease. We’ll start with a new paper on one major effort here. CRISPR gene editing. This process often involves cutting DNA, which then can be used as an opening to …

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Weekly reads: BioCardia, HeLa suit, illegal bio lab in CA

August 6, 2023 August 5, 2023 / By Professor Paul Knoepfler, Ph.D. / Leave a Comment

A days ago the news came about Mesoblast not getting FDA approval for its MSC product for GvHD. The MSC area has had a rough few years with various clinical trials including for COVID. The “stem cells for heart disease” arena has also had a tough time. Here’s more news along these lines: BioCardia pauses enrollment in PhIII trial …

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Update on stem cells & cell therapy for COVID trials

July 26, 2023 August 3, 2023 / By Professor Paul Knoepfler, Ph.D. / Leave a Comment

From the beginning of the pandemic, I have been mostly skeptical about the idea of cell therapy for COVID including stem cell therapies. However, at the same time, I’ve closely followed the data, especially up until 2022. Now having just had a nasty bout with COVID myself for the first time this summer, I recently …

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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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