Search Results for: stem cell clinics

ARM Asks FDA for Clarification on Draft Guidance on Minimal Manipulation

Alliance-for-Regenerative-Medicine

In the last few months the FDA has taken steps toward crystalizing regulatory oversight of stem cell and more broadly cell and tissue-based therapies. These steps come in the form of several draft guidances  (see here, here, and here) . The Alliance for Regenerative Medicine (ARM) has responded to the draft guidance on Minimal Manipulation. For example, ARM has […]

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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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Comments Policy

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Comments are encouraged. Those comments submitted to this blog will be posted at the sole discretion of the editor. Comments also may be edited for content. For example, comments cannot include person attacks, promotional material for stem cell clinics, or other inappropriate content. Commenters are encouraged to use their real names, but anonymous comments are

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The Moriguchi iPS transplant fable: key lessons & where do we go from here

More and more evidence is accumulating that the alleged iPS cell transplantation in human patients by Dr. Hisashi Moriguchi was bunk. Nature today has a piece out today on the story providing more quotes about the case that suggest the whole thing was made up. Rather than re-hash all the details, in this post I’m going

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Real and imaginary conflicts of interest: a helpful guide

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What are Conflict of Interests (COI)? The term COI is sometimes used inappropriately as a weapon by one party to attempt to discredit others. We see this more and more frequently in the stem cell field with boosters of for-profit, non-FDA vetted adult stem cell clinics attacking scientists for supposed COIs for what…..apparently for simply

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NASA’s wickedly up & down week: broader lessons about science & medicine

All science, whether biology or physics, whether microscopic or at the solar system level, is about experiments. Sometimes we as a society forget that. In fact, experiments are at the heart of investigations as diverse as studying cells to exploring space to medical treatments. For NASA, the last week has been a tale of two

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Dr Lookgood, dermatologist to the stars, gets FDA warning letter

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If you ever had a really bad day, March 13, 2012 might have been just such a bad day for one Dr. Steven Victor, aka “Dr LookGood”, because he received an official warning letter from the FDA. Why? Dr. Victor, who reportedly greets each patient with the catch phrase “You look so much more beautiful than your picture”, is

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