Maybe SOME Good News from the FDA

Curious when they said you may get some benefits from the procedure? Have you gotten any thus far if so, what are they? Have you experienced any side effects that you weren’t told?

Sure… Stay woke, son.

I will and you keep the blinders on and make them happy.

According to the doctors who treated me, the results should become apparent within 1-3 months, but sometimes as long as 6-9 months (Frequently Asked Questions About Regenexx Cayman). Presently I’m 16 days out and have had minimal pain in all of the treated joints since the procedure despite being off all NSAIDs; however, the symptoms normally wax and wane over time, so it’s still too soon to assess the results. I also haven’t resumed working out yet, which will be the real test. The only adverse effect was some pretty bad swelling around my ankles after the injections, but that has since subsided.

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Cool. If I remember correctly, this has been giving you grief for a long time. Politics and whatnot aside, I hope you’ve found something that brings you relief.

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For your procedure(s), were your MSC’s ‘bone marrow derived’ or ‘adipose derived’?

I ask because the former is completely legal here in the US. (obviously, it’s also a much more invasive extraction as compared to the latter)

As for the latter, the FDA currently considers it “drug therapy” because collagenase is a required addition to the liposucted(?) adipose, in order to free up the MSC’s therein.

And there are stateside doctors who’ve successfully petitioned for FDA-exemptions for therapeutic usage of adipose-derived MSC’s.

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The cells used for my treatment were bone marrow derived, but the crucial issue is that they were culture-expanded to increase their numbers from about 1M original cells to a final count of about 250M. It’s the culturing process that FDA considers tantamount to drug manufacture, and they would never consider an exemption for my purposes.

Very cool, thanks for sharing.

Also, how many hours (days?) did it take to get to that 250x proliferation?

I’m not sure how long the cells were in culture but it was probably about 2-3 weeks total. You have to make two trips to the Grand Cayman for this reason. The cells were frozen in cryostorsge for three months between the second and third passages and only brought out for the third a few days before my return visit—in that short time they went from 44M to over 250M.

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Please keep us posted on your results.

Any legitimate reasons why stem cell therapy should not be allowed in this country? Not the smoke in mirrors excuse from the FDA at the behest of Big Pharma, most likely like the “consumer protection” aspect. Just making the public suffer, in the meantime, so more money can be made. Totally disgraceful.

Even before science caught up a little the public already knew the benefits of medicinal marijuana without the double-blind randomized studies. So those who believe that no treatment ought to be legalized until it is confirmed by studies, you have egg on your face. Cannabis and Cannabinoids (PDQ®)–Patient Version - NCI

Stem Cell support and the importance of EPC’s The Importance of Endothelial Cells for Aging and Health - Stem-Kine

Tell me, Zep, have you ever read up on the history of hormone-replacement therapy for women of menopausal age and it’s presumed benefit for cardiovascular disease?

If you haven’t, here’s a quick primer:

For a couple decades, it was presumed that post-menopausal women would experience cardioprotective benefits from estrogen therapy. This was based primarily on expert opinion, anecdotal evidence, and non-randomized observational studies. The belief was so strongly entrenched that, in fact, that many doctors argued it would be unethical to randomly assign patients in a double-blind study, because they were so sure that estrogen therapy was cardioprotective.

I’ll let you look up the results of the HERS-I, HERS-II, and WHI studies to see how that turned out.

After 6.8 years, hormone therapy did not reduce risk of cardiovascular events in women with CHD. Postmenopausal hormone therapy should not be used to reduce risk for CHD events in women with CHD.”

“Overall health risks exceeded benefits from use of combined estrogen plus progestin for an average 5.2-year follow-up among healthy postmenopausal US women. All-cause mortality was not affected during the trial. The risk-benefit profile found in this trial is not consistent with the requirements for a viable intervention for primary prevention of chronic diseases, and the results indicate that this regimen should not be initiated or continued for primary prevention of CHD.”

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That’s exactly why we do the studies, even when the answer is ‘obvious.’

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And why isn’t this related to medicinal marijuana where there is a huge lack, if any, studies done to prove it;s benefits? Should the public suffered while it waited for confirmation? And what of all the tens of thousands who are being helped with stem cell therapy?

So what about the million plus of public fools who are saying they’re receiving benefits from medicinal marijuana? Not to mention the tens of thousands of people who have been helped with stem cell therapy, should they be made to wait or be able to make their own decisions about their own health?

I guess you missed this, but the point of the hormone-replacement example above is that “confirmation” isn’t always as “confirmative” as you think it’s going to be; in fact, sometimes studies that are supposedly going to be just “confirmatory” tell us that a therapy which is widely perceived to be helpful is ineffective, or sometimes even dangerous. That’s why studies are important. It’s not about making the public suffer while they wait for confirmation; you’re looking at it through the wrong end of the glass. It’s about making sure the therapy is actually working before it’s widely approved. Otherwise, you end up with stories like the HRT experience.

I’ve explained this too many times by now to go over it again.

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I guessed you missed the fact that tens of thousands of people have already had a far better outcome with stem cell therapy than others who’ve tried the garbage drugs from pharma that are designed to manage symptoms rather than treat the cause.

Over 1M people have used medicinal marijuana. In fact they prefer it over the garbage drugs offered by pharma. Since it was legalized 20 years ago in California why have 27 other states + D.C. followed suit despite there being no double-blind randomized studies? If we followed your logic this would still be illegal and people would be suffering left without the choice.

I’ve explained this too many times by now to go over it again. You may have tried to explain it but your reasoning is incredibly weak. The FDA is doing nothing but protecting markets for Big Pharma all the while making the public suffer. You are looking at things wrongly. We probably have the worst “healthcare” system in the industrialized world in terms of it’s treatment of chronic/degenerative diseases. The public spends roughly twice as much as anyone else in the world and the U.S. is ranked 37th in overall outcomes. It is time we join the rest of the world and adopt some form of single-payer system. Our’s is run primarily for the benefit of Big Pharma.

Endothelial Progenitor Cells. The Importance of Endothelial Cells for Aging and Health - Stem-Kine