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 Based on new draft guidance …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: stem cell good news, bad news on sickle cell, MS, IPSCs

victoria gray family crispr sickle cell b

Let’s start with some stem cell good news on evolving approaches to treat sickle cell disease involving stem cells. Then on another related front things were more concerning. Stem cell good news on sickle cell disease, a complication Sickle Cell Disease News reports Adding Briquilimab Boosts Success of Sickle Cell Stem Cell Transplant. This is a …

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Wrinkles in pitch of celeb fav Augustinus Bader cream

Kris Jenner, Jennifer Aniston, Augustinus Bader cream

Many celebs seem to be into cosmetics called Augustinus Bader cream products that claim to do something related to stem cells. The brand is wildly expensive. What’s this all about? Augustinus Bader is both a person and a line of cosmetic products. The goal of today’s post is to fact-check the claims and products of the Augustinus …

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Fact-checking stem cell stroke therapy: hope but not there yet

Stem cell stroke therapy

Stem cell stroke therapy research has generated buzz over the years. The goal of today’s post is to fact-check claims about supposed stem cell stroke therapies and educate readers on where clinical research stands. There is some real hope here in the long run, but things have been greatly exaggerated at times. Some clinics are …

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Weekly reads: Gamida Cell, Siddhartha Mukherjee, CRISPR in viruses

Abigail L. Jenkins, Gamida Cell

Hematopoietic stem cells have many clinical applications and a company called Gamida Cell has an interesting product in this area called Omidubicel that may have several applications.  I’m going to start the weekly reads with news there. Gamida Cell and the FDA A recent piece discussed how Omidubicel is progressing with the FDA. FDA extends …

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Updates on CRISPR therapy development and clinical trials

When I first heard of CRISPR gene editing I was excited for my lab to try it out, but it seemed a long way from the field having even one CRISPR therapy available to treat human disease. In the Knoepfler lab, we study genetic and genomic programming in human development and disease. Gene editing seemed …

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Review of ExoFlo paper used to push Direct Biologics IND inside FDA finds red flags

ExoFlo from Direct Biologics

I wrote recently about how political pressure on FDA Commissioner Stephen Hahn in 2020 may have helped the Texas firm Direct Biologics move their product ExoFlo forward inside the agency. Today I analyze the ExoFlo Phase I clinical trial paper used in that push on Hahn to get the firm the IND for a Phase II …

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