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 Based on new draft guidance …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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FDA leader Stephen Hahn was pressured to aid Texas firm Direct Biologics

Former FDA Commissioner Stephen Hahn.

An FDA FOIA dump of text messages of former Commissioner Stephen Hahn suggests that a Texas regenerative firm called Direct Biologics benefited from political pressure on him in mid-2020. Then he was asked again to help in early 2021. This was shortly before he resigned at the start of the Biden Administration. The push came from …

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Paper sparks renewed interest in transdifferentiation & clinical potential

transdifferentiation, iOPCS

There was a time when I thought transdifferentiation based approaches might quickly move into clinical trials. Then things kind of cooled off. We didn’t see many papers reporting methods to transdifferentiate cells. I still think that this technology, sometimes called direct reprogramming, has major potential. A new paper on making human brain cells this way got …

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Fact-checking exosome therapy: costs, risks, & lack of data

model of an exosome, exosome therapy

Exosome therapy is a still-experimental cell therapy approach aimed at treating specific diseases using secretions from cells. It’s novel since most attention on cell therapies has been given to using the actual cells themselves. In addition, this approach is a newer idea than using cells as the drug to treat diseases. Interestingly, the term “cell …

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In big shift Dr. Robert Lanza exits Astellas

Dr. Robert Lanza

The recent news of Vertex Pharma buying small stem cell biotech ViaCyte and Doug Melton moving to Vertex brought to mind an old stem cell biotech called Advanced Cell Technology (ACT) and its leader, stem cell biologist Dr. Robert Lanza. Years ago, big pharma firm Astellas bought ACT and Lanza moved to be a leader of regenerative …

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ViaCyte purchase puts Vertex in driver’s seat on stem cells for diabetes

Doug Melton, Vertex, ViaCyte

When I’m asked about the most promising areas of stem cell clinical research, cell therapy for type I diabetes is near the top including work by a biotech called ViaCyte. Other firms are in the mix too, boosting the overall odds of success in the coming decade. It’s really that promising even though there are …

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Giostar stem cell clinic chain review, red flags, & lawsuit

Giostar

Some unproven stem cell clinics like one called Giostar have multiple locations sprouting up. To me the concern with that spreading is the potential of multiplying risks to consumers. It can be hard to get a clear take on what these clinics are doing too. What’s in this article What is Giostar? | Giostar review | …

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