Category: Amniotic Fluid/Umbilical Cord Blood/Wharton’s Jelly/Placenta

FDA Just Reaffirmed That You Can’t Use Umbilical Cord Blood in Orthopedics Without A Drug License Or Specific Permission Thru a RMAT Or Other FDA Program

3/29/2019
https://lnkd.in/eR7Jpq2
FDA clearly states that umbilical cord blood is NOT exempt from registering as a biologics drug under section 351.
FDA states that “….using the umbilical cord blood products to treat orthopedic conditions is not homologous use as defined in 21 CFR 1271.3(c).”
If you are using or selling umbilical cord blood for use in orthopedics, regardless of stem cell claims or not….you better register thru section 351 or get a RMAT!!!

#orthopedics #stemcells #stemcell #regenerativemedicine #orthobiologics #orthopedicsurgeon #scams

Stop the “Umbilical Cord Blood is a Stem Cell Injection” Scam

Don’t get scammed by a clinic selling “umbilical cord blood as a living stem cell”. The clinic in question has been in Plano and Arlington Texas for a long time defrauding patients….

Hello XXXX XXXX, DC, I saw a patient today to whom your clinic was attempting to sell a knee stem cell injection from umbilical cord blood for osteoarthritis. There are no living stem cells in umbilical cord blood which is why these products are registered as section 361 products with the FDA. If there were actually living stem cells in the product, then your clinic would be noncompliant with FDA regs by injecting an allograft stem cell product in a non homologous use into a non 1st/2nd deg. relative, without a RMAT designation or an IND/BLA with the FDA. I have now had 3 former patients asking if I will support a potential consumer fraud lawsuit against your clinic. Selling 1-2cc of umbilical cord blood as a FDA compliant living stem cell injection is indeed fraudulent in my opinion and is harmful to patients seeking out your clinic for professional care. I am taking the time to write you because I think these people have the truth and are angry at the deceit and fraud. You and your partners should realize the medico-legal liability you are assuming in case you didn’t have a clue before.

Just released Amniotic Fluid “Stem Cell” Documentary exposes one common scam…

I tell all patients that the easiest thing to remember is that for an orthopedic stem cell procedure to be legal, verifiable, and to have published human clinical outcomes for the condition being treated…..the stem cells HAVE to come from their own bone marrow.

Please avoid the “Stem cell out of a bottle scams that are still common in this growing field”

Another Blog Review With A Summary Of Amniotic Fluid/Umbilical Cord Blood/Placental Tissues

The use of these products in orthobiologics is not illegal.  Selling and promoting them as actual stem cell injections would mean that they have been approved by the FDA as a biologic drug…..and none of these products have passed that standard.  Patients need to be very sure of what they are paying for with orthobiologic procedures so that they aren’t charged and given a procedure that is not what was advertised!

The link is to a blog post by Chris Centeno, MD who is the Chief Medical Officer of Regenexx which has published more literature in orthobiologics over the past 10 years than any other clinic, physician, or vendor.

FloGraft Review: Does this Product Contain Live Stem Cells?