Search Results for: California Stem Cell Treatment Center

Reactions to California’s new stem cell law on non-FDA approved clinic offerings

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What does the wide stem cell and regenerative medicine community think of California’s new stem cell law requiring that clinics selling non-FDA approved stem cell offerings make specific disclosures to prospective customers and that the state medical board keep track of how this all unfolds? You probably already know that I am supportive of the […]

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New FDA Inspection 483s: Insights on Stem Cell Clinic & Cell Surgical Network

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Two new FDA inspection reports called 483s provide fresh insights on a stem cell clinic, the network of clinics that it belongs to, and adverse events in patients. These reports detail issues the FDA found at the stem cell clinic California Stem Cell Treatment Center and its parent chain of clinics, Cell Surgical Network. The

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Stem cell clinic group, Cell Surgical Network, fires PR back at FDA

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Cell-Surgical-Network

The FDA took some big action last week and issued a major statement today on stem cell clinics (see my post here). I asked Dr. Mark Berman of the Cell Surgical Network if he had any statement regarding the recent action and statement from the FDA today that involved flagship network member clinic, California Stem Cell

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Six questions as FDA takes new shot at stem cell clinics

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FDA

The FDA issued a historic statement today promising to more clearly define its regulatory policies on stem cell therapies and to take strong action on some stem cell clinics that it views as “bad actors”. I’ve never the FDA use such clear-cut language before. I give big kudos to new FDA Commissioner Scott Gottlieb. It already

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Narrowed Stemgenex suit proceeds as court implies stem cell clinic loopholes

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Stemgenex

Can California stem cell clinics make questionable marketing claims about their experimental, non-FDA approved offerings as long as they are not demonstrably false? Do such clinics not bear any legal requirement to provide informed consent to patients? A new court ruling raises such striking questions. San Diego stem cell clinic Stemgenex sells non-FDA approved experimental stem

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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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Asterias interview: stem cell spinal cord injury trials advance

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Asterias

Recently I had the opportunity to talk with the leadership of Asterias, a California biotech doing exciting clinical research using stem cells as the basis for treatment of spinal cord injury. The interview covers the past (Geron patients), present, and future. I spoke with Asterias President and CEO Stephen Cartt and CMO Edward Wirth. How

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Stem cell clinic Nervana new ad claims no side effects & FDA OK

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Stem cell clinics like Nervana are spreading like wild-fire across the U.S. A few months back the Sacramento area got a new stem cell clinic selling amniotic stem cell therapies for a variety of ills including most prominently arthritis and pain. This clinic is called Nervana Stem Cell Center. I first noticed it via a

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Eureka: Endogenous Stem Cells Regrow New Lens for Cataracts

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A team of researchers from Sun Yat-sen University in China and here in California at my graduate alma mater UCSD has published a remarkable, new report in Nature reporting human lens regeneration in cataracts. This is a truly amazing idea that endogenous stem cells can regrow new lenses. I wonder if we are on a path to someday

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