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Originally Posted by Mathmarm
My neighbor had frozen stem cells injected in each knee. Fresh ones cost twice as much. Her ortho surgeon did it. Said it was new and FDA approved.
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I know you are just repeating what you were told, but if bad information is not challenged people remember the lie.
The FDA did not approve of the treatment your neighbor received.
From the FDA website
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Stem cells, like other medical products that are intended to treat, cure or prevent disease, generally require FDA approval before they can be marketed. FDA has not approved any stem cell-based products for use, other than cord blood-derived hematopoietic progenitor cells (blood forming stem cells) for certain indications...FDA cautions consumers to make sure that any stem cell treatment they are considering has been approved by FDA or is being studied under a clinical investigation that has been submitted to and allowed to proceed by FDA.
FDA has approved only one stem cell product, Hemacord, a cord blood-derived product manufactured by the New York Blood Center and used for specified indications in patients with disorders affecting the body’s blood-forming system.
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Additionally, the majority of the unregulated stem cell clinics at least will only use your own harvested cells from your own fat tissue. That way they are injecting your cells back into you. No issues with transmitting disease or causing immune issues. This is a loophole the stem cell clinics use to say they do NOT need FDA approval as they are just giving you back your own tissue. This is a slimy, IMO, twisting of the phrase FDA approved.
From Regenexx's website on this issue:
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Are the Regenexx procedures performed in the U.S. approved by the FDA?
Yes – The Regenexx procedures performed in the United States are compliant with CFR 21 Part 1271 and fall under the same surgery exemption discussed in 1271.15 (b).
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See what they did there? They wrote the question with the word "approved", but answered "yes ..are compliant". What that means is that they are operating under an exemption from needing approval as there is no foreign material being injected, just your own cells. So not really approved, in fact, they depend on NOT needing approval because they claim to be exempt.
Clinics which claim to be using anonymous donor cells? Frozen? How were the donors screened? Keep in mind the clinic already lied to you about FDA approval of their procedure. And using other person's cells is not exempt. There are FDA approved studies of stem cells. But then you would have been given an informed consent that you were in a study and likely not been charged anything for your willingness to be a study subject.