Many unscrupulous regenerative medicine clinics are telling patients that because their clinic is doing a “study”, or sometimes an “IRB study”, their procedures are allowed by the FDA. This is simply not true. Many orthobiologics are regulated by the FDA and if there are claims of stem cells in the product, then the FDA definitely is involved. As we have seen in recent publications, the birth tissue products do not have living functional stem cells when thawed in a doctor’s office in 5 minutes so all of those products tested to date by independent university level researchers have shown no significant stem cells in them! Furthermore, if they DID have stem cells in them, they would still be in violation of FDA regulations because they would be need to be regulated as biologic drugs and none of those companies have applied or paid or done the research necessary to type of regulatory clearance from the FDA. The best advice? Avoid ANY clinic trying to sell you stem cells that are not from your own body.
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