clinicaltrials.gov

FDA outlines potential crackdown on Clinicaltrials.gov offenders

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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 Based on new draft guidance …

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Clinic biz US Stem Cell reports SEC subpoena, adding to uncertainty on its future

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The last few years for the publicly-traded stem cell clinic biz, US Stem Cell, Inc., which goes by the ticker $USRM, have seemed like a rollercoaster to me as an observer. I can see four main areas of news that to me make the future seem uncertain for this firm. First, the US Stem was linked to the …

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Sen. Grassley asks tough questions for FDA on U.S. Stem Cell, blinded women

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Early in 2016, we started hearing about patient allegations of having been blinded in Florida by at least one stem cell business and several allegations seemed linked to a publicly-traded company called U.S. Stem Cell, Inc. (USRM). In turn, there have been a number of lawsuits involving USRM, including one filed just a few months …

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Stem cell clinic-related biz threatens researcher with lawsuit, wants retraction

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University of Minnesota bioethicist Leigh Turner has been threatened with a lawsuit by a stem cell clinic-related business. Lawsuit threats in this arena come up every so often and as much as they are unpleasant realities, they can also reveal some important aspects of the stem cell arena. Ars Technica reported yesterday that Leigh’s recent paper …

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NEJM paper links 3 blinded patients to publicly-traded stem cell clinic

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Do 3 blinded stem cell clinic patients with major or complete vision loss constitute a significant adverse outcome? I would say so and a new paper details how this happened apparently at a particular publically-traded South Florida stem cell clinic business. You can see the damaged retinas of one such patient below in an image from a …

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Predatory stem cell clinics are winning: what can we do?

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For years I have been working to educate the community about the predatory stem cell clinics out there. These clinics prey on vulnerable patients and their families. The clinics use hope as a marketing tool. A weapon. As the number of such clinics has mushroomed in the US and elsewhere the risk to both patients …

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Stem cell clinics, FDA, & giant, unapproved for-profit human experiments

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When I started blogging in 2010 the stem cell arena was a very different place including the fact I could count the number of US stem cell clinics on one hand. This blog, called The Niche for many years, was just “Knoepfler Stem Cell Blog” back then. Also, back then the hot topic was the …

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Super Cells exhibit and why we bother with public outreach

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Guest post by Lisa Willemse Last month, on this blog, Paul wrote an article about loopholes in the clinicaltrials.gov database that allows for-profit companies to advertise their “therapies” under the guise of a registered clinical trial. This is a real concern for our community, especially those among us who have recommended the clinicaltrials database as …

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

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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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