stem cell law Archives - Page 3 of 4

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

October 5, 2017 / Professor Paul Knoepfler, Ph.D. / 6 Comments

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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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Groundbreaking new California stem cell law gives consumer protections on clinics

October 3, 2017 / Professor Paul Knoepfler, Ph.D. / 12 Comments

California now has a first-of-its-kind stem cell law that requires clinics pitching non-FDA approved stem cell offerings to be upfront with patients. It’s a bill that will help to protect patients. How? With Jerry Brown’s signature yesterday, the new California law mandates that stem cell clinics in our state take some steps to inform patients

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REGROW Act to do reappearing act?

October 30, 2016 / Professor Paul Knoepfler, Ph.D. / 1 Comment

One of the biggest stem cell news stories of 2016 has been the REGROW Act, a bill intended to accelerate investigational stem cell and regenerative medicine therapies to patients by lessening FDA oversight, but in the last couple months REGROW has mostly disappeared from the news. Will REGROW do a reappearing act like some kind

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REGROW Act 2.0 still no-go with big risks to patients & field

July 5, 2016 / Professor Paul Knoepfler, Ph.D. / 10 Comments

The REGROW Act is a bill that seeks to lessen the regulatory burden to accelerate getting stem cells to patients more quickly, but it over-reaches so much that it would almost certainly do harm to patients and maybe to the stem cell field as a whole. The REGROW Act, which is sponsored by Senator Mark

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Is REGROW Act anti-embryo research? Pluripotent stem cells excluded

May 4, 2016 / Professor Paul Knoepfler, Ph.D. / 10 Comments

The REGROW Act has attracted both support and criticism, including on this blog, for the changes it would mandate in the way the FDA regulates stem cell products. More specifically it would greatly reduce regulation of experimental stem cell products. I believe that would be dangerous to patients and to the stem cell field more

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Alliance for Regenerative Medicine (ARM) Opposes REGROW Act, Risks to Patients Cited

April 10, 2016 / Professor Paul Knoepfler, Ph.D. / 31 Comments

The biggest debate today in the stem cell world is over how much regulation is needed for new, investigational stem cell therapies that are not as yet approved. Sometimes it feels very lonely being out there publicly advocating for appropriately thorough regulation of stem cell therapies and at times I get a lot of heat for

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REGROW Act is Attack on Science-Based Stem Cell Trial Oversight

March 28, 2016 / Professor Paul Knoepfler, Ph.D. / 21 Comments

Senators Mark Kirk, Joe Manchin, and Susan Collins have proposed new legislation in the form of the REGROW Act that would substantially interfere with the FDA’s ability to properly regulate the development of new stem cell and regenerative medicine therapies based on hard science. The REGROW Act would force the FDA to allow rushed introduction of experimental stem

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More on alleged stem cell clinic fraud: statement from David Audley

January 16, 2015 / Professor Paul Knoepfler, Ph.D.

This week the big Winnipeg Free Press story on the Regenetek/Doug Broeska alleged stem cell fraud case broke (covered here on this blog). David Audley was quoted in the story as a Regenetek spokesperson so I asked him for further comment and below is what he emailed me for this post. David Audley: “1. GoodPartners

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What would federal prison be like for a non-compliant stem cell doc?

June 28, 2013 / Professor Paul Knoepfler, Ph.D. / 6 Comments

About a year ago, I heard from multiple credible sources that there were ongoing federal probes into potential criminal activities related to bogus or dangerously noncompliant stem cell medical interventions, which could lead to prison time. Since then it has been relatively quiet….that is until the last couple months when again I am hearing from

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Refuting potential downsides to stem cell drug court ruling

July 26, 2012 / Professor Paul Knoepfler, Ph.D. / 9 Comments

There was a burst of feeling last night in the stem cell community as word began circulating that a federal court had ruled in favor of the FDA defining manipulated stem cell products as drugs. However, not everyone was pleased with the court ruling. The clinics most directly affected by the ruling were understandably upset,

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