Search Results for: US Stem Cell

Wouldn’t you like to be a RAT too? Stem cell clinics apply for new FDA accelerated approval path

RAT-RMAT-designation

Are stem cell clinics going to somehow get the FDA to approve their stem cell interventions? To get recognized as legit? It seems they are trying now more than ever. Remember the REGROW Act that would have greatly reduced regulations on investigational stem cells and then how the 21st Century Cures Act passed with some […]

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Splashy SacBee Ad for Stem Cell Clinic Nervana Raises More Questions

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This morning my local paper The Sacramento Bee ran a full-page, super splashy ad for the local stem cell clinic, Nervana. Remarkably the ad says, “As Seen in The Sacramento Bee”, referring to an article by reporter Claudia Buck that ran in the past in the SacBee Insight section that raised many concerns and questions about Nervana. I may have

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On Duke stem cells for autism trial, did new CNN article hit the mark?

DawsonKurtzberg

What’s the scoop on stem cells for autism? Could stem cells make a real difference for autism patients and their families? CNN has a big, high-profile new article out today on the Duke stem cell trial for autism that has been ongoing for a while and I’m wondering how good a job CNN did on

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LA Times Reports Stemgenex Doc Gets 3-Year Probation from State Medical Board

Stemgenex-Doctors

The world of stem cell clinics is on edge right now with a number of negative patient outcomes reported and lawsuits in play such as San Diego stem cell clinic Stemgenex being a defendant in a proposed class action lawsuit focusing in part on alleged problematic marketing claims on their website (see archived posts on the lawsuit).

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FDA warns Northwestern’s Richard Burt on reporting patient deaths, other issues in stem cell trials

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The FDA recently issued a lengthy warning letter to Northwestern University over the clinical trial practices of its Dr. Richard Burt and this letter just popped up on the FDA website. To my knowledge this is an unprecedented event as I’m not aware of another warning letter to a major university for a stem cell trial. Burt received the FDA

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Guest Post from the Maryland Stem Cell Research Fund

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By Amritha Jaishankar Happy Maryland Day from the Maryland Stem Cell Research Fund (MSCRF) at Maryland Technology Development Corp. (TEDCO)! This year, here at MSCRF, we are skipping the crabs, old bay and beer and choosing instead to spend the weekend engaged in scientific review! As we commemorate the day the first settlers stepped on to

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Does stem cell clinic IRB approval mean much? Insights from blinding cases

stem-cells-eyes, stem cell therapy side effects.

Could the blinding of three women at a stem cell clinic have been prevented by better oversight or was the clinic acting outside of the scope of oversight by its institutional review board (IRB)? More broadly, when is an IRB conducting proper oversight and how do we know? When on the other hand is it

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A tale of two stem cell retractions: stark contrast between Macchiarini & Egli

Macchiarini-retraction

A paper retraction is a major, painful step in science, but sometimes it is necessary and in the past few weeks we’ve seen news of two high-profile stem cell paper retractions. However, these retractions were handled entirely differently by those involved and were prompted by very distinct situations. Update: for some background on stem cell

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