I recently visited a local stem cell therapy practice to ask some questions. I then sent them an email summarizing the information that was presented to me and ask more questions. Below is the email exchange in response to such. It is a look into alternatives to medicine and the thinking of its proponents.
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HER: Thank you, Tom, for reaching out. Our services are certainly not FDA approved and I apologize if someone at our office gave you that impression. The kits that are used to harvest the stem cells are FDA cleared to harvest and process the cells. However, there is no FDA approval on treating joint pain with stem cells. Did someone at our office tell you differently? We also don’t have any record of you coming in today or even calling the clinic. I just want to verify that you were told by us at (redacted) and not somewhere else.
ME: I walked in a few days ago and the person specifically told me that the treatment was FDA approved and has been for 5 years. She was clear that it was for treatment and not for research.
HER: I apologize that happened Tom. No one in our office should’ve ever told you that. I will make sure I say something to the team today. Again there must’ve been some confusion on her end in terms of FDA approval for treatment or the harvesting process. I would be happy to give you a lay of the land on the FDA stance and all this if you want to give me a call personally on my cell phone at (redacted). We’ve been doing this for almost 6 years and I can give you a really in-depth breakdown of how the FDA feels about all the stuff. I look forward to hearing from you And again I apologize for any confusion.
ME: Thanks (redacted). I was just curious about how you folks can practice without FDA approval.
HER: I would be happy to explain if you want to give me a call.
ME: "Please know that if you are being charged for these products or offered these products outside of a clinical trial, you are likely being deceived and offered a product illegally. Likewise, FDA is aware that patients and consumers are being referred to clinicaltrials.gov, or are told that a product is registered with FDA, as a way to suggest that the products being offered are in compliance with FDA laws and regulations. This is often false. The inclusion of a product in the clinicaltrials.gov database or the fact that a firm has registered with FDA and listed its product does not mean the product is legally marketed."
https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and-consumer-information-about-regenerative-medicine-therapies
If you have information contradicting the FDA, I would be interested in being enlightened. Otherwise, I am not interested, I think I understand the situation.
HER: I appreciate your passion for the subject. This June 2021 ruling has been in the making for 3 1/2 years. What it essentially did was shut down all of the "off the shelf" products as those were the ones making false claims and treating for systemic issues. As far as stem cells from your own body, OrthoCarolina, for example, does bone marrow aspirate injections for OA, despite not having FDA approval, so this is nothing our clinic or other stem cell clinics are just doing roughly on our own. If you are interested in further reading, check out the FDA distinction between a 361 vs a 351 in terms of cellular products. Autologous stem cells are considered a 361 and not a drug and a 351 has to be registered as a drug. There are many holistic and alternative procedures in medicine that are being used on people every day that are not FDA approved. I would agree with the FDA in that many of these are making false claims because they are not regulated by any agency, but there are also some really good products out there helping people.
ME: I assume from your response that the materials you folks are using are in the 361 category. Thus, they have not been tested for safety and effectiveness. Are you clearly telling your patients such?
Your sentence (" There are many holistic and alternative procedures in medicine that are being used on people every day that are not FDA approved. I would agree with the FDA in that many of these are making false claims because they are not regulated by any agency, but there are also some really good products out there helping people.") is troubling.
The use of "holistic" and "alternative" suggests quackery. How do you know that your procedures are safe and effective without research testing? All of what you are doing could just as well be a placebo (and an expensive one at that).
HER: There are all kinds of scientific research out there, studies, white papers, clinical research, etc on the effectiveness of stem cells treating OA. Please feel free to do a google search and you will see how much it is out there. We believe the science is there to support the treatments we offer. And like anything, FDA approved or not, you will see plenty of negative to go along with the positive :) Stem cell therapy has been studied for years. Again, the safety and effectiveness of harvesting the stem cells is FDA 510k cleared and has been extensively researched for safety. What we are really talking about here is the actual treatment of OA with stem cells. Does it really help or doesn't it?
In my opinion, there is much more than just effectiveness as to why the FDA has not approved any of these treatments. Stem cell therapy is a threat to the cash cow of big pharma and the hospital medical system that currently exists. X-ray or your knee, a cortisone shot (plenty of scientific research out there now showing that extensive cortisone shots will deteriorate a joint). Didn't work. MRI of your knee. Lets try another cortisone shot, maybe some gel shots or some pain medications. That didn't work, lets do a $40,000 surgery. Many of these pain medications people have received are FDA approved, yet are so addicting and ruined lives.
Although I do agree with you using the word "holistic" or "alternative" can suggest quackery, I do think it is unfair to label those terms as 100% negative. Like anything professional, there are good and bad. There are good doctors and bad doctors, there are good restaurants and bad restaurants, there are good lawyers and bad lawyers, etc. I personally enjoy going to a Chiropractor for aches and pains. I also prefer to take natural supplements for ailments vs medications.
I am not sure what the end game of this conversation is, but from my point of view, we are having a healthy debate on the topic. I hope that is the way you see it too. I respect your position and your beliefs and the last thing I want to come out of this conversation is anything negative.
ME: Thanks for the respectful dialogue. I see no reason to continue. Take care and have a good day.
HER: Same to you, Tom.
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