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Surprising FDA audit report of Celltex a blow to dubious stem cell clinics

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As I first reported, the FDA conducted a two-week audit of Texas adult stem cell firm, Celltex, sometime in April. Today I received a copy of the so-called “483 report” of that audit. It is basically a summary of problematic issues that the FDA says need to addressed. The FDA report is cause for some …

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Rick Perry’s Texas two step spin on stem cells

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The Texas State Medical Board reportedly approved new rules for the use of adult stem cells. The ruling was at least in part a result of Texas Governor and former GOP presidential hopeful, Rick Perry, strongly pushing the issue. Perry himself received a controversial, non-FDA approved stem cell transplant in 2011 as part of a …

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Claim of Liz Parrish DIY gene therapy linked to unlicensed stem cell clinic

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In a strange, but fascinating tale recounted by Antonio Regalado in an article over at MIT Tech Review, we hear the first claim of a do-it-yourself (DIY) gene therapy. The owner of a small biotech called BioViva, Liz Parrish, reportedly traveled from her home in Seattle to get an unapproved, experimental gene therapy in another …

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Celltex FDA FOIA Letter #3 Raises Key New Questions

This is the fourth post in a series I’m doing on an FOIA release of letters between Texas stem cell clinic Celltex and the FDA. The first three posts, which include helpful background and discussion of other FOIA material from Celltex, can be found here, here, and here. Today’s post is focused on a newly …

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