Anybody hear of Wharton's Jelly?

Posted by cindiwass @cindiwass, Nov 28, 2021

If so and more specifically, were there positive reviews? A newspaper here (South Florida) has an ad about Wharton's Jelly as a treatment for joints like knees, claiming that Medicare will pay for it. So I wonder -- anyone know personally if it relieves pain? Specifically hip and knee. Anyone tried it?

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Well, Cindi, I learn something new from Connect every single day.
Certainly the concept of using umbilical cord substances to help repair our bodies sounds wonderful. I suspect there is much work to do before it is ready, but it would be exciting to get into a trial to deal with the arthritis that is attacking spine, knees, elbows, shoulders...and has already done a lot of damage to my hands and hips!

Here is a recent article that points to the fact that numerous studies are underway, but there a few if any published peer reviewed studies that I can find yet.

The FDA says these cells are human tissue, and are regulated as such and must be administered by a qualified medical professional. Currently they do not appear to have given final approval for any specific treatment. As of August 2020 they were not covered by Medicare.
As of June - August 2021, the FDA issued letters stating there were no products approved for administration outside of clinical trials.

There is one company named Regenerative Labs which recently issued notice that they have 2 FDA approved products covered by Medicare/Medicaid, but I cannot find independent corroboration.

Where did you hear about this? Are you thinking about checking further into trying it?
Sue

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Hi, Sue. I read about it in an ad in the local newspaper here. South Florida. (Sun-Sentinel) It says it's "covered by Medicare," so I figured it must be some sort of legitimate therapy, but I don't like doing anything now in my old-er age unless I have to. My knee and hip are giving me so much pain and instability but I am loathe (very reluctant) to get operations. However, I may not be able to avoid this in the long-short run. Time is running out -- I'm 78 now. But my mobility and energy are severely limited due to the pain. I've been to many doctors, had multitude of x-rays taken, they all tell me I need to be operated on. I want to learn more about it, both for the substance and how it is harvested as well as comments from those who have had it or know someone who has. I'll be reading some reports about it which I found on line.
P.S. Yes, the company in the ad is Regenestem.

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@sueinmn

Well, Cindi, I learn something new from Connect every single day.
Certainly the concept of using umbilical cord substances to help repair our bodies sounds wonderful. I suspect there is much work to do before it is ready, but it would be exciting to get into a trial to deal with the arthritis that is attacking spine, knees, elbows, shoulders...and has already done a lot of damage to my hands and hips!

Here is a recent article that points to the fact that numerous studies are underway, but there a few if any published peer reviewed studies that I can find yet.

The FDA says these cells are human tissue, and are regulated as such and must be administered by a qualified medical professional. Currently they do not appear to have given final approval for any specific treatment. As of August 2020 they were not covered by Medicare.
As of June - August 2021, the FDA issued letters stating there were no products approved for administration outside of clinical trials.

There is one company named Regenerative Labs which recently issued notice that they have 2 FDA approved products covered by Medicare/Medicaid, but I cannot find independent corroboration.

Where did you hear about this? Are you thinking about checking further into trying it?
Sue

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I read this interesting article now about it, Sue. I still want to do some more research. https://www.drneelaminmd.com/contents/treatments/stem-cells

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@cindiwass

I read this interesting article now about it, Sue. I still want to do some more research. https://www.drneelaminmd.com/contents/treatments/stem-cells

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Cindi - I don't know what your pain tolerance is, but I found the pain relief from surgery, plus the increased quality of life in being able to function again were well worth the surgery and rehab. I lost count of my ortho surgeries for arthritis, and I always forget the work of rehab until I am doing it, but each operation has been worthwhile.

I cannot find any evidence that Regenestem or Dr Neil Amin's company has FDA approval for Wharton's Jelly, which has been declared an "allograft" - use of human tissue from one human in the body of another - which does in fact require approval. Stem cells are a different story, and have been approved for some uses.

Here is what the FDA has to say: https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and-consumer-information-about-regenerative-medicine-therapies

Let me know what you find, both about FDA approval of specific Wharton's Jelly suppliers, and about whether Medicare actually covers the service.
Sue

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Hi Cindi, I would really be cautious. Like Sue, I think it might not help you and has a possibility of making things worse. Here's some information I found from 2021 on the topic.

"Orthobiologic injections, for example the placenta- and umbilical cord–derived Wharton’s jelly, are currently being harvested and sold by companies as an off-the-shelf “stem cell” injection for conditions including back pain and osteoarthritis. For example, a 36-year-old male was injected with Wharton’s jelly for low back pain, and within 24 h he developed fevers, chills, polyarthritis, and Achilles tendon enthesitis [60]. Infectious disease work-up was negative. Inflammatory markers were elevated, and he was positive for HLA-B27 antigen. Initial treatment included methylprednisolone and sulfasalazine. This example highlights the unknown dangers of these allogenic injections, and physicians should remain cautious about their use until further study and regulation can ensure patient safety."
--- Reactive Arthritis Update: Spotlight on New and Rare Infectious Agents Implicated as Pathogens: https://link.springer.com/article/10.1007/s11926-021-01018-6

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OK, I've been doing some research on the product, and the ad here (Fort Lauderdale) says it is covered by Medicare, which makesme think it's ok. But after reading the above posts, I get scared. I'm scared of everything anyway. Yet I'm working on getting my pressure down so that I can have a hip operation, followed by a knee operation. Not looking forward to it, but hoping my pain level goes down once I get the operations. So thanks.

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@sueinmn

Cindi - I don't know what your pain tolerance is, but I found the pain relief from surgery, plus the increased quality of life in being able to function again were well worth the surgery and rehab. I lost count of my ortho surgeries for arthritis, and I always forget the work of rehab until I am doing it, but each operation has been worthwhile.

I cannot find any evidence that Regenestem or Dr Neil Amin's company has FDA approval for Wharton's Jelly, which has been declared an "allograft" - use of human tissue from one human in the body of another - which does in fact require approval. Stem cells are a different story, and have been approved for some uses.

Here is what the FDA has to say: https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and-consumer-information-about-regenerative-medicine-therapies

Let me know what you find, both about FDA approval of specific Wharton's Jelly suppliers, and about whether Medicare actually covers the service.
Sue

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I checked the website from the fda you have above. Fwightening is all I can say. Glad you provided it. I will check with the FDA if I can. Too bad - it looked so alluring. 🙁

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@cindiwass

OK, I've been doing some research on the product, and the ad here (Fort Lauderdale) says it is covered by Medicare, which makesme think it's ok. But after reading the above posts, I get scared. I'm scared of everything anyway. Yet I'm working on getting my pressure down so that I can have a hip operation, followed by a knee operation. Not looking forward to it, but hoping my pain level goes down once I get the operations. So thanks.

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I had both hips replaced a year and a day between the two. Made life bearable. Now my left knee is begging for relief. I am 73 and had polio as an infant. Totally paralyzed from it. The pain in the knee keeps me too sedentary and the older we get the more risk anesthesia causes brain fog which may not go away. Have your surgeries from a competent surgeon and spare yourself pain, worry, and immobility. Best to you. Would be skeptical about whartons jelly if I had seen the ad.

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@tarmansbks

I had both hips replaced a year and a day between the two. Made life bearable. Now my left knee is begging for relief. I am 73 and had polio as an infant. Totally paralyzed from it. The pain in the knee keeps me too sedentary and the older we get the more risk anesthesia causes brain fog which may not go away. Have your surgeries from a competent surgeon and spare yourself pain, worry, and immobility. Best to you. Would be skeptical about whartons jelly if I had seen the ad.

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Yes, I looked up the info provided here about Wharton's Jelly and am not convinced it's safe for me to use, no matter what the providers say right now. I've had several operations (starting about 60 years ago because someone knocked me down in a h.s. basketball game and my knee got damaged -- that started it all, had an operation to remove part of the cartilege (that's what I remember they said). It was "ok" for some years after that (I was young) but when I was in my 30's the knee would swell up and they would extract fluid from it. That's what they did back then. That hurt when they did that, also I would get cortisone injections from time to time. The doctor 'kindly' said [sarcasm here] that I would be crippled by the time I was 50. OK, I lasted until about 10 years ago or so when my hip must have been sympathetic with my dear knee, even though it appeared to be stronger than my left leg. Anyway -- I've been holding off having an operation because I'm -- scared. HOWEVER, the quality of my life is so bad that I can't keep putting it off. As I said, I finally went to a recommended surgeon here who said in order for him to operate I'd need to get my pressure down. So I'm working on that. I'm also having thyroid problems, so -- it may be I won't be able to have an operation, I'll keep working on it. Thanks for your experience. It always helps to hear from others. When you say you are totally paralyzed from polio as an infant, what do you mean? I know someone who is in my age category who contracted polio as a child and has one leg smaller than the other. But how are you doing?
Yes, if I could bear the pain and could do daily chores I would not consider the operation. But -

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There is a great deal of hope and a great deal of hype about stem cell treatment. That is why Mayo Clinic offers a free consult service. When you call the consult service, they will tell you about the availability of approved stem cell therapy at Mayo Clinic and elsewhere, and for what conditions. They can also tell you about research studies that are actively recruiting participants. Furthermore, you can add your name to a database to be notified when additional studies and information become available. You can learn more about the Consult Service here http://www.mayo.edu/research/centers-programs/center-regenerative-medicine/patient-care/clinical-services/regenerative-medicine-consult-service.
Or call 1-844-276-2003 to speak with one of our experts.

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