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Wall Street Journal Op Ed Calls Out FDA’s Cell Regulation Nonsense

“Common sense is not so common”-Voltaire This spring, an important Wall Street Journal Op-ed by the ex-FDA commissioner called out the FDA for inhibiting progress by classifying our cultured Regenexx-C procedure a drug, pointing out the FDA’s cell regulation nonsense.  Yesterday morning the Wall Street Journal published a second op-ed on the cells=drugs issue and the FDAs…
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Cells=Drugs Update-The End of the First Half of our Landmark Case

Cells=Drugs Update-The End of the First Half of our Landmark Case  As many of you know, the US FDA believes that our Regenexx-C cultured stem cell procedure is a drug. We disagree for a number of reasons, not the least of which is if the FDA can declare your cells under certain circumstances drugs, then you can no longer…
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ACA Ruling and “One Sized fits All” Medical Care

For those of you that follow this blog, you know that it was only a matter of time before I commented on the ACA and the ACA ruling by the Supreme Court. Regardless of your personal politics, as a physician, I can see a few things I like and many things that are a serious problem for…
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Knee Injections for Arthritis-How recent Research about Hyaluronic Acid shows we have a Problem with our Research System

The most common knee injections for arthritis is likely cortisone-which causes severe side effects including death of a significant number of knee stem cells and cartilage cells. The second most common is SynVisc or some other form of hyaluronic acid (HA). HA is an injectable gel that replaces lost lubricating fluid in the knee. I tell my patients…
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Petition to Change the FDA’s “Your Cells=Drugs” Policy

We’ve been a staunch opponent of the FDA’s cells=drugs initiative as it makes little common nor public health policy sense. Recently, ex-FDA commissioner Dr. Andrew von Eschenbach jumped in through publishing a Wall Street Journal Op Ed and and agreed that the policy was stifling innovation. What’s the issue?  Under certain circumstances, the cells in your body can be classified as drugs.…
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How Big would the FDA have to be to Supervise Physician Stem Cell Use?

The Texas Medical Board ruling that stem cell use is the practice of medicine and not the creation of a new drug has brought up some interesting issues. Continuing along the lines of the cells= drugs discussion, what happens if I turn your cells into drugs? There are certainly bioethical concerns like whether you can use them to save your life-you can’t…
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Texas Medical Board puts Rules around Stem Cell Use

As I have blogged before, Texas is shaping up to be a showdown over physician innovation with stem cells. In the Texas Medical Board stem cells ruling the Texas Medical Board (TMB) voted 11-4 yesterday to pass a new rule (Chapter 198) that allows physicians to use stem cells that are not FDA approved under the…
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Cells=Drugs takes a Scientific Hit

Transplanting organs is difficult because the host’s body rejects the foreign tissue. Since mesenchymal stem cells are anti-inflammatory and can modulate an immune response, one company has been trying to help the dreaded disease of severe organ rejection (GVHD or Graft vs. Host Disease). This company placed someone else’s mass manufactured stem cells in a vial in a…
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