John Knab, M.D.’s Post

John Knab, M.D.

I can figure out why you hurt, and how to help. Without drugs. Without surgery.

5mo Edited

Today's effort at patient education: "Are Stem Cells Illegal?" MSK and Spine autologous cellular therapy injections (like #BMAC and #mFAT) may be considered "exempt" from FDA regulation --- when performed under the proper circumstances, and when specific criteria are met. On the other hand, there are currently ZERO (Zero.Point.Zero) FDA -approved "Stem Cells in a Vial" products for use in the treatment of MSK and Spinal Conditions in the USA. So if you got an invitation for the "Informational Seminar on Stem Cells" at your local steakhouse in the mail, and you show up and they start talking about Exosomes, Wharton's jelly, umbilical cord blood, and amniotic fluid, you might want to skip dessert and skeedaddle. I can't believe that these companies are still getting away with advertising, promoting, and distributing these products in 2024! Hopefully this video helps to clarify! https://lnkd.in/e4EBcuKV

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Transcript

Are stem cells illegal? Well, first of all, here's a pro tip. We don't actually call them stem cells anymore. Nowadays we call them MSC's, which stands for medicinal signaling cells. In the fields of orthopedics and spine in the United States, when we talk about stem cell therapy. We're really talking about BMAC, which is short for Bone marrow aspirate concentrate or M fat, short for Micro Fragmented Adipose Tissue. And the reason we don't call them stem cells anymore is because the cells were getting. From our bone marrow in fat don't actually grow directly into new cartilage, ligament, or bone. Instead, right after we inject them using precise ultrasound, precise fluoroscopy. Whichever mode we choose, they stick to damaged areas of tissue and begin secreting natural biologic chemicals that attract other cells from your body to the areas of damaged tissue. And this is how these cells actually. Function and help to reduce pain and improve function. Unfortunately, so far we're not really able to say that injecting BMAC or Mfat allows us to grow new tissue. Sorry. BMAC and MFAT are not approved by the FDA. Does this make them illegal? No, it does not. As long as the BMAC are empat are taken from your body in a specific way. On the same day that they're going to be injected back in. They are exempt from FDA regulations. If your doctor believes you might benefit from the injection of B Mac or Mfat, this is allowed and it's called the practice of medicine. So what kind of stem cells and products in the regenerative medicine field are illegal? Since 2017, the FDA has been very clear, extremely clear about their position on certain products when they're being used. Orthopedic problems. These things are commonly referred to as stem cells in a vial. They go by names like Amniotic Membrane, Amniotic Fluid, Wharton's Jelly, Umbilical Cord, Blood and Exosomes. And even though for very specific conditions like eye disease and wound care, they're 100% legit and legal, in all other cases they're not allowed. The main reason that these products are not allowed by the FDA is safety. These are biologic products, and the FDA considers them to be drugs in In order to get your product approved by the FDA as a drug, you gotta spend a ton of money. And go through lots of steps and take years and years of time to ensure that these drugs are both safe and effective. And a lot of these companies just weren't taking those steps. They thought they didn't have to. Now these products come from afterbirth, like the placenta and umbilical cord, and then are taken to a lab and processed into sellable products by manufacturing companies. Have you ever been in a live birth? I have. It's not a sterile process, kids. There's blood, body fluids, and yes, even pee and poo. And when some of these companies were collecting the placenta and umbilical cord, they weren't taking the proper sanitary steps and the birth tissue became contaminated. Bacteria and viruses got into the products and they were injected into people right here in the US. Some people got very sick and some even died. These products were injuring people, even though they were coming from official looking companies with slick marketing and what appeared to be sterile glass files. But they weren't sterile. Even though these birth tissue products are considered illegal by the FDA, believe it or not, you can still buy them. And many doctors are still doing this, some of them because they don't know any better. Man, just continue believing what their sales reps tell them or what they see in an e-mail. And others just really don't care about the safety issues. If you're trying to avoid surgery or you've been told that you can't have surgery. Fix your orthopedic or spinal condition. You may start looking at stem cell therapy as an option. If so, you really need to take ownership of your own care and find out exactly what type of cells are going to be injected into your body. Hopefully you're working with the legitimate Doctor Who knows what they're doing and knows the laws. If not, and they start mentioning exosomes, Wharton's Jelly or other things. Find a new Doctor immediately. The only types of stem cells which you now know are called MSC's you should be talking about with your doctor or the ones that come from you. If they're coming from a glass vial, beware. Thanks guys.

Dr V. R. Ravi MS (Ortho)

Dr V. R. Ravi MS (Ortho)

Director at Mothercell Regenerative Centre

5mo

In every Conference or CME program I attend almost every month,for the last 2 years I have been talking on only "Indian govt DCGI/FDA approved stemcell therapy products - Stemone from Alkem for Osteoarthritis and Regenacip for diabetic nonhealing foot ulcers and Burger's disease". These 2 are stemcells available in a bottle/ bag for any Orthopedic surgeon or vascular surgeon in India. While "BMAC is already a procedure and not a product and hence not under our mandate ' is what our Drug controllers have repeatedly told in our conferences whenever invited to discuss about the regulatory framework for Regenerative medicine techniques.

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John Knab, M.D.

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