Autologous mesenchymal stem cells are turning out to be one of the most underappreciated advancements in medicine today, and scandalously the FDA is slowing progress in the field by seeking to prevent doctors from harvesting and reintroducing one's own stem cells back into the body.
MSC's can be harvested from one's own adipose tissue with a little bit of liposuction.
The process of separating the stem cells from fat is called stromal vascular fraction.
It's an astoundingly easy process to do [1]. The equipment is inexpensive, and so far the procedure has been shown to be safe.
MSC's have been shown to improve COPD, and reduce the allergic response that triggers asthma. Skin damage healed, cartilage and joint injuries repaired, and even MS put in to remission,
MSC's administered via IV flock to areas of inflammation and damage and begin to repair it. The cells know what to do. Local administration is even better, as in this study or in cases of back pain and joint injuries.
Autologous treatments should not be considered biological drugs and subject to monopolization by biotech companies through decade long clinical trials and FDA approval.
These are our own cells from our own bodies. Doctors should be free to practice and innovate in this sphere, and in this case innovation is mostly just dosage, frequency and delivery method because the cells know what to do.
I believe that in the next decade or two, autologous stem cell treatments will be basic preventative care for everyone, a treatment each year will repair damage before it becomes pathology.
I've been working with MSCs for more than 15 years, mostly in stroke, and I agree completely. It's worth noting that this trial used donor cells, and that might be part of the reason they don't remain after a couple of months. There is evidence that autologous cells persist longer, likely because they aren't swept up by immune rejection.
What we and others have found is that age of the donor inversely correlates to their therapeutic potential. For that reason, I founded Forever Labs, Inc. http://www.foreverlabs.co/
We bank young MSCs so that they can be preserved for therapy later in life. I banked my own two months ago.
We prefer bone marrow MSCs as the BM also contains blood progenitor and stem cells, whereas adipose tissue does not.
*We are fast expanding and raising; email in bio. ;)
> and scandalously the FDA is slowing progress in the field by seeking to prevent doctors from harvesting and reintroducing one's own stem cells back into the body.
According to this article, what you're referring to is just the FDA putting stem cells under the same regulatory burden as most drugs.
They have escaped this previously because the stem cells came from the patient, and not much was done to the cells before re-injection, so it's closer to plastic surgery.
I happen to think that that FDA is probably way too conservative (both on stem cells and drugs) and seriously inhibits progress, but I think it's misleading to suggest that they are slowing progress in a way specific to stem cells. The FDA has always had a mission to not just protect patients from harm, but also from being fleeced by useless sham therapies.
The FDA has a lot of blood on its hands. Everyone, especially a chronically ill person on their deathbed, should be free to choose whatever experimental medical procedure they want. Not only is this a recognition of self-ownership, but it would provide invaluable medical research and could accelerate getting effective treatments to the ill.
My grandfather died of COPD, and likely so will my Dad. He has COPD. And was diagnosed in his 50s. I am fearful of it myself, but thankfully unlike both of them I've never smoked.
It is a shot in the dark, but do you know anything off hand of having him participate in something like this in the US?
The brain is immune privileged, so there is more leeway to use donor cells if that is the destination. Which isn't the case in most uses of stem cell transplants, as you point out.
The FDA is protecting people against sham treatments. The whole reinjecting things that come from your body canard has been around awhile -- look at PRP treatments for example. No compelling evidence exists that it actually works, but tons of clinics offer it because Tiger Woods got it once. There is a legitimate danger with stem cells that you could introduce cancer (this has happened in some studies).
I suspect that the processes to produce these will get patented if not the results, but it's still encouraging that new treatments can be made by using cells from our own bodies.
The primary difference between this and most of the stem cell therapies delivering mesechymal stem cells - which are more or less the standard type of cell to use for the moment, the most studied and most characterized, no-one got fired for using mesenchymal stem cells, etc - such as those widely available via medical tourism is the delivery to the brain. That isn't something clinics do, for all the obvious reasons.
So I'm inclined to think that this is one of a number of different studies in recent years to demonstrate that the delivery methodology makes just as much of a difference as the type of cell lineage and any tinkering done to that cell lineage.
They've been doing this kind of thing over in China for some time now[1]. Science with a capital 'S' doesn't happen until the U.S does it though, and until that point and time all procedures are considered risky and dangerous. Even if you're going to die before any of it gets approved, you better not do any of this stuff.
Many people are aware that soon after President Obama took office, he authorized federal funding of embryonic stem cell research, which President Bush had resisted. The Obama administration made a big deal out of it at the time:
What got swept under the rug was that at the same time, President Obama specifically rescinded a previous executive order that directed the HHS to "conduct and support" research using adult stem cells:
I don't think the Obama administration ever spelled out why, at the same time it was promoting ESCR, it decided to also deprioritize adult stem cell research, but I think this latest news -- along with all of the other advances of the past eight years -- has shown that moral issues aside, adult stem cell research is paying high dividends.
> I don't think the Obama administration ever spelled out why, at the same time it was promoting ESCR, it decided to also deprioritize adult stem cell research
It was all part of the same EO, which was accompanied on the same day by a Presidential Memorandum on scientific integrity in government decisionmaking on science and technology, and the rationale for the set of policy changes was explicitly to move toward allowing decisions on what avenues of science to pursue (not the goals, but the routes to the goals) to be guided by science rather than politics.
It wasn't deprioritizing adult stem cell research, it was letting the relative priority of adult stem research be set, and adjusted, over time based on science, rather than being set by political directive.
yeah, they say that the stem cells actually disappear after about a month but improvement continues well afterward. and they say its because of growth factors released by these cells.
Is it possible that the procedure itself, the act of drilling and poking needles into the brain, stimulated the improvement? The stem cells didn't linger and they're precursors to skeletal muscular cells so maybe they actually had no effect on the outcome? Is it possible/ethical to do studies where they drill and poke into the brain without injecting stem cells?
You should compare that 7/18 with what happened to other 18 in the same condition. 1 year after stroke, it is quite safe to say that 0/18 would have any improvement in 1 month (the patients were testes also 1 month after).
"Significant improvement" is 10 points on a 0-100 scale. Maybe others had what to their family would be significant improvement, but it didn't quite exceed the marker.
With one intervention using donor cells in 12 months, for stroke patients, that could be a big deal.. with improvement to the procedure or combining with other treatments maybe more could be achieved.
What I found to be worrying is that the researchers seems to be unclear about how MSC is causing the improvements.
Also the improvements continues after the stem cells have disappeared. This seems to suggest the effect doesn't come from the MSC, but rather the chemicals the cell produces. Does that mean if we can synthesis the chemicals, we don't need the cell?
[+] [-] willholloway|9 years ago|reply
MSC's can be harvested from one's own adipose tissue with a little bit of liposuction.
The process of separating the stem cells from fat is called stromal vascular fraction.
It's an astoundingly easy process to do [1]. The equipment is inexpensive, and so far the procedure has been shown to be safe.
MSC's have been shown to improve COPD, and reduce the allergic response that triggers asthma. Skin damage healed, cartilage and joint injuries repaired, and even MS put in to remission,
MSC's administered via IV flock to areas of inflammation and damage and begin to repair it. The cells know what to do. Local administration is even better, as in this study or in cases of back pain and joint injuries.
Autologous treatments should not be considered biological drugs and subject to monopolization by biotech companies through decade long clinical trials and FDA approval.
These are our own cells from our own bodies. Doctors should be free to practice and innovate in this sphere, and in this case innovation is mostly just dosage, frequency and delivery method because the cells know what to do.
I believe that in the next decade or two, autologous stem cell treatments will be basic preventative care for everyone, a treatment each year will repair damage before it becomes pathology.
[1] https://www.miltenyibiotec.com/~/media/Files/Navigation/Rese...
[+] [-] markkat|9 years ago|reply
What we and others have found is that age of the donor inversely correlates to their therapeutic potential. For that reason, I founded Forever Labs, Inc. http://www.foreverlabs.co/
We bank young MSCs so that they can be preserved for therapy later in life. I banked my own two months ago.
We prefer bone marrow MSCs as the BM also contains blood progenitor and stem cells, whereas adipose tissue does not.
*We are fast expanding and raising; email in bio. ;)
[+] [-] jessriedel|9 years ago|reply
According to this article, what you're referring to is just the FDA putting stem cells under the same regulatory burden as most drugs.
https://www.statnews.com/2016/02/08/fda-crackdown-stem-cell-...
They have escaped this previously because the stem cells came from the patient, and not much was done to the cells before re-injection, so it's closer to plastic surgery.
I happen to think that that FDA is probably way too conservative (both on stem cells and drugs) and seriously inhibits progress, but I think it's misleading to suggest that they are slowing progress in a way specific to stem cells. The FDA has always had a mission to not just protect patients from harm, but also from being fleeced by useless sham therapies.
[+] [-] ancap|9 years ago|reply
[+] [-] mgr86|9 years ago|reply
My grandfather died of COPD, and likely so will my Dad. He has COPD. And was diagnosed in his 50s. I am fearful of it myself, but thankfully unlike both of them I've never smoked.
It is a shot in the dark, but do you know anything off hand of having him participate in something like this in the US?
[+] [-] echelon|9 years ago|reply
[+] [-] reasonattlm|9 years ago|reply
http://www.san-bio.com/product/
The brain is immune privileged, so there is more leeway to use donor cells if that is the destination. Which isn't the case in most uses of stem cell transplants, as you point out.
[+] [-] guelo|9 years ago|reply
[+] [-] dataangel|9 years ago|reply
[+] [-] Natsu|9 years ago|reply
[+] [-] rhizome|9 years ago|reply
[+] [-] unknown|9 years ago|reply
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[+] [-] atomical|9 years ago|reply
[+] [-] Omnius|9 years ago|reply
[+] [-] umanwizard|9 years ago|reply
[+] [-] reasonattlm|9 years ago|reply
So I'm inclined to think that this is one of a number of different studies in recent years to demonstrate that the delivery methodology makes just as much of a difference as the type of cell lineage and any tinkering done to that cell lineage.
[+] [-] narrator|9 years ago|reply
[1] https://www.reddit.com/r/IAmA/comments/fu2ub/as_requested_i_...
[+] [-] jawns|9 years ago|reply
https://www.whitehouse.gov/the-press-office/removing-barrier...
What got swept under the rug was that at the same time, President Obama specifically rescinded a previous executive order that directed the HHS to "conduct and support" research using adult stem cells:
https://www.cellmedicine.com/obama-executive-order/
I don't think the Obama administration ever spelled out why, at the same time it was promoting ESCR, it decided to also deprioritize adult stem cell research, but I think this latest news -- along with all of the other advances of the past eight years -- has shown that moral issues aside, adult stem cell research is paying high dividends.
[+] [-] dragonwriter|9 years ago|reply
It was all part of the same EO, which was accompanied on the same day by a Presidential Memorandum on scientific integrity in government decisionmaking on science and technology, and the rationale for the set of policy changes was explicitly to move toward allowing decisions on what avenues of science to pursue (not the goals, but the routes to the goals) to be guided by science rather than politics.
It wasn't deprioritizing adult stem cell research, it was letting the relative priority of adult stem research be set, and adjusted, over time based on science, rather than being set by political directive.
[+] [-] mrfusion|9 years ago|reply
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[+] [-] Malician|9 years ago|reply
With one intervention using donor cells in 12 months, for stroke patients, that could be a big deal.. with improvement to the procedure or combining with other treatments maybe more could be achieved.
[+] [-] lintiness|9 years ago|reply
[+] [-] nialv7|9 years ago|reply
Also the improvements continues after the stem cells have disappeared. This seems to suggest the effect doesn't come from the MSC, but rather the chemicals the cell produces. Does that mean if we can synthesis the chemicals, we don't need the cell?
[+] [-] rpedela|9 years ago|reply
[+] [-] imjustsaying|9 years ago|reply
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[+] [-] paxcoder|9 years ago|reply
[+] [-] dang|9 years ago|reply
https://news.ycombinator.com/newsguidelines.html
https://news.ycombinator.com/newswelcome.html
[+] [-] ceejayoz|9 years ago|reply