Search Results for: clinicaltrials.gov

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 Based on new draft guidance …

FDA outlines potential crackdown on Clinicaltrials.gov offenders Read More »

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 …

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

Behind the scenes at Clinicaltrials.gov with 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 …

Behind the scenes at Clinicaltrials.gov with Director Deborah Zarin Read More »

Bluebird Bio sickle cell gene therapy trial halted on cancer worry

bluebird bio, sickle cell gene therapy

Recently I was going through a list I’m updating of regenerative medicine biotech companies including Bluebird Bio. Now just a few days later the world seems turned upside down for the firm and maybe to some degree for other companies doing related work. Bluebird Bio blues: 2 trial participants get cancer News broke today that …

Bluebird Bio sickle cell gene therapy trial halted on cancer worry Read More »

Mesenchymal cells or MSCs: definition, stem cell fraction, & trial map

mesenchymal cells, MSCs, mesenchymal stem cells

I confess that I’m old enough to remember when the acronym MSC stood unambiguously for “mesenchymal stem cells”, but should it refer to a broader term like “mesenchymal cells”? The field has moved in that direction. I think that’s the best way to go too and I’ll explain why. The goal of today’s post is …

Mesenchymal cells or MSCs: definition, stem cell fraction, & trial map Read More »

What are induced pluripotent stem cells or IPS cells & clinical prospects?

induced pluripotent stem cells clinical trials map

Induced pluripotent stem cells or IPS cells just might be the most exciting development in the stem cell field over the last 15 years. They have unique potential for clinical impact for regenerative medicine too, both through their use to produce differentiated cellular therapies and indirectly via disease modeling as well as drug screening. The …

What are induced pluripotent stem cells or IPS cells & clinical prospects? Read More »

What are totipotent stem cells & what can they do?

very early human embryos totipotent stem cells

Sometimes patients or my students ask me, “What are the best stem cells?” what information are they looking for? I think they often are looking for the most powerful stem cells so perhaps they should be asking, “What are totipotent stem cells?” Other times it seems what patients specifically want to know is what might …

What are totipotent stem cells & what can they do? Read More »

More Duke autism program backstory: stem cell ‘magic’ & money

Duke-Curemark-autism-study-pamphlet

Last week I wrote a long post detailing the troubling multimillion-dollar reverberations between the Duke autism program and a for-profit stem cell clinic in Panama called The Stem Cell Institute. The potential entanglements between the Duke group and the Panama clinic raise a bunch of questions and concerns. They center on questionable, unproven autism “treatments”. …

More Duke autism program backstory: stem cell ‘magic’ & money Read More »

Overview of IPS cell prospects for clinical impact

IPS-cell-clincial-trials-map

IPS cell research is a growing area of promise for regenerative medicine. These stem cells, also known as iPSCs or more formally as Induced Pluripotent Stem Cells, are engineered cells that are programmed to function the same way as embryonic stem cells. They can be differentiated into possibly any type of cell that is needed for …

Overview of IPS cell prospects for clinical impact Read More »

Does Duke autism team partly have Panama stem cell clinic to thank for $10s of millions?

Drs.-Neil-Riordan-and-Joanne-Kurtzberg-MSCs-for-autism

What do a Panama stem cell clinic and the Duke autism program have in common? More than I might have imagined. There is a puzzle when it comes to the controversial idea of using cord blood for autism, because two of the strongest proponents are the autism cord blood program at Duke and for-profit, unproven …

Does Duke autism team partly have Panama stem cell clinic to thank for $10s of millions? Read More »