15 ms·

Autologous mesenchymal stem cells are turning out to be one of the most underappreciated advancements in medicine today, and scandalously the FDA is slowing pro

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. [1] https://www.miltenyibiotec.com/~/media/Files/Navigation/Research/Stem%20Cell/SP_MSC_lipoaspirate_protocol.ashx https://www.miltenyibiotec.com/~/media/Files/Navigation/Rese...

echelon 10y ago
Wouldn't there be the concern that the cells would regulate themselves differently when introduced into a new environment?
- willholloway 10y ago
  The procedure has been done tens of thousands of times all over the world, so far it's been incredibly safe.
  - mrfusion 10y ago
    Are there other countries that are starting to specialize in this? Do you think we might see a black market form in the us?
    - mernster 10y ago
      There are companies in the US that will set you up in Mexico or the Cayman islands where the regulations are more favorable (in that they do not exist). It's pretty exciting. FDA is lagging, but it's hard to blame them for caution given all the troubles they've experienced since the 90s.
    - willholloway 10y ago
      There are still clinics in the US that will perform this procedure, despite FDA pressure. I am not an expert in the specifics of why or how, but I do know that this is reducing the number of doctors treating patients with MSCs and increasing the cost. I don't want to travel to Mexico or Thailand or even Europe to have this simple procedure, and I don't want to wait 10 or 15 years and then have to pay monopolist, proprietary pricing for what would be an inferior technique compared to what a free, open source medical science would inevitably produce.
reasonattlm 10y ago
Not autologous in this case. http://www.san-bio.com/product/ 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.
- markkat 10y ago
  Actually, the brain is not as immune privileged as was long thought. Only last year, lymphatic vessels were identified in the brain. https://www.nih.gov/news-events/nih-research-matters/lymphatic-vessels-discovered-central-nervous-system https://www.nih.gov/news-events/nih-research-matters/lymphat...
markkat 10y ago
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/ 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. ;)
- willholloway 10y ago
  I think you just landed yourself a customer :) MSC benefits are fantastic at replacing lost or damaged cells, however they are not bio-rejuvenation in the sense of turning back the clock with younger cells, unless one were to bank one's own younger cells? If that is true, it would be, in a sense, an early SENS hack. Very interesting. Will contact.
  - markkat 10y ago
    Sounds great! :) There has been some animal work that suggests transplantation may have that effect: http://www.ncbi.nlm.nih.gov/pubmed/23967009 http://www.ncbi.nlm.nih.gov/pubmed/23967009 http://www.ncbi.nlm.nih.gov/pubmed/25707248 http://www.ncbi.nlm.nih.gov/pubmed/25707248 There is much research to be done, but the technology to transplant young bone marrow stem cells to one's older self exists today. To be honest, that is part of my personal motivation. 'Autologous stem cell time travel' is low hanging fruit. We preserve the cells in multiple aliquots with the assumption that they might be used for multiple purposes, including expansion.
- msane 10y ago
  If you banked your cells today at the age of 30, how much therapy can be hypothetically produced from that in the future? Is it a store that depletes as you use it? Or can banked stem cells be replicated to create more reserves?
deleted 10y ago
[deleted]
jessriedel 10y ago
> 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. https://www.statnews.com/2016/02/08/fda-crackdown-stem-cell-clinics/ 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.
- willholloway 10y ago
  In this case the therapy is not useless or a sham, and it is autologous which has traditionally been an exempt area in this respect. That the FDA has overturned its own history and precedent is the scandal, imho. A benefit has been shown, to what degree and in which circumstances is being ironed out. There is some hope, the FDA has liberalized to some degree in recent years and biotech has been a top performing sector. We live in miraculous times.
  - jessriedel 10y ago
    I don't think you disputed my point. > In this case the therapy is not useless or a sham More precisely, in this case you believe there is enough evidence that the therapy is effective, but the FDA does not yet agree that has been established. Then, in congruence with its policy on unproven medical procedures, the FDA has severely constrained stem cell procedures. > and it is autologous which has traditionally been an exempt area in this respect. It's clear that there was little/no enforcement in this area previously, but now they have announced clarification that it is to be enforced. You may call that a change in the regulatory environment, but it doesn't appear to be a change in general policy. The situation is very similar to 23andMe. 23andMe was flying under the radar and, when the FDA cracked down on them, they experienced a changed in their effective regulatory environment, but this is not reasonably interpreted as the FDA changing its tune (or overturning history or precedent or whatever). Again, I wish the FDA allowed more of these things to proceed (including 23andMe and stem cells) but I don't think this is change.
mgr86 10y ago
> MSC's have been shown to improve COPD 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?
- willholloway 10y ago
  There are clinics and doctors that have been performing the procedure, lowest cost I have seen is $7k for a treatment. They can harvest, isolate and deliver his own MSC via IV and perhaps nebulizer. It seems like the doctors that have been performing are silos of information right now. There is not a lot published on the web of their experience as practicing doctors, some of the best on the ground info I have found is from interviews of doctors practicing. There are also very many published MSC trials showing a benefit. It is a terrible thing to not be able to breathe well. I hope that this can help.
  - mgr86 10y ago
    Thanks! I will try my best to look into this and hope he is willing. He doesn't talk about it much.
ancap 10y ago
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.
- nbb 10y ago
  So every con artist should be unrestricted in selling false hope to the most desperate of us?
  - kafkaesq 10y ago
    Do you realize that this a straw man argument?
    - nbb 10y ago
      I don't realize that because it's not.
      - rhizome 10y ago
        It wasn't a strawman, but it was a pretty aggressive argument in bad faith.
        marshray 10y ago
        You've never worked in a specialist medical clinic. Edit: not intended to sound ad hominem
        rhizome 10y ago
        a) How do you know? b) The phrase you're looking for is "argument from authority," which it is.
guelo 10y ago
If the cells are already in your body what's the point of extracting them just to reinject them back in?
- smt88 10y ago
  The cells are not injected into the same part of the body that they were extracted from.
rhizome 10y ago
Incredible post, thank you so much for a clear and concise overview.
Natsu 10y ago
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.
atomical 10y ago
What about androgenic alopecia? Is there potential there?
dataangel 10y ago
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).

echelon 10y ago

Wouldn't there be the concern that the cells would regulate themselves differently when introduced into a new environment?

willholloway 10y ago
The procedure has been done tens of thousands of times all over the world, so far it's been incredibly safe.
- mrfusion 10y ago
  Are there other countries that are starting to specialize in this? Do you think we might see a black market form in the us?
  - mernster 10y ago
    There are companies in the US that will set you up in Mexico or the Cayman islands where the regulations are more favorable (in that they do not exist). It's pretty exciting. FDA is lagging, but it's hard to blame them for caution given all the troubles they've experienced since the 90s.
  - willholloway 10y ago
    There are still clinics in the US that will perform this procedure, despite FDA pressure. I am not an expert in the specifics of why or how, but I do know that this is reducing the number of doctors treating patients with MSCs and increasing the cost. I don't want to travel to Mexico or Thailand or even Europe to have this simple procedure, and I don't want to wait 10 or 15 years and then have to pay monopolist, proprietary pricing for what would be an inferior technique compared to what a free, open source medical science would inevitably produce.

reasonattlm 10y ago

Not autologous in this case. http://www.san-bio.com/product/ 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.

markkat 10y ago
Actually, the brain is not as immune privileged as was long thought. Only last year, lymphatic vessels were identified in the brain. https://www.nih.gov/news-events/nih-research-matters/lymphatic-vessels-discovered-central-nervous-system https://www.nih.gov/news-events/nih-research-matters/lymphat...

markkat 10y ago

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/ 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. ;)

willholloway 10y ago
I think you just landed yourself a customer :) MSC benefits are fantastic at replacing lost or damaged cells, however they are not bio-rejuvenation in the sense of turning back the clock with younger cells, unless one were to bank one's own younger cells? If that is true, it would be, in a sense, an early SENS hack. Very interesting. Will contact.
- markkat 10y ago
  Sounds great! :) There has been some animal work that suggests transplantation may have that effect: http://www.ncbi.nlm.nih.gov/pubmed/23967009 http://www.ncbi.nlm.nih.gov/pubmed/23967009 http://www.ncbi.nlm.nih.gov/pubmed/25707248 http://www.ncbi.nlm.nih.gov/pubmed/25707248 There is much research to be done, but the technology to transplant young bone marrow stem cells to one's older self exists today. To be honest, that is part of my personal motivation. 'Autologous stem cell time travel' is low hanging fruit. We preserve the cells in multiple aliquots with the assumption that they might be used for multiple purposes, including expansion.
msane 10y ago
If you banked your cells today at the age of 30, how much therapy can be hypothetically produced from that in the future? Is it a store that depletes as you use it? Or can banked stem cells be replicated to create more reserves?

deleted 10y ago

[deleted]

jessriedel 10y ago

> 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. https://www.statnews.com/2016/02/08/fda-crackdown-stem-cell-clinics/ 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.

willholloway 10y ago
In this case the therapy is not useless or a sham, and it is autologous which has traditionally been an exempt area in this respect. That the FDA has overturned its own history and precedent is the scandal, imho. A benefit has been shown, to what degree and in which circumstances is being ironed out. There is some hope, the FDA has liberalized to some degree in recent years and biotech has been a top performing sector. We live in miraculous times.
- jessriedel 10y ago
  I don't think you disputed my point. > In this case the therapy is not useless or a sham More precisely, in this case you believe there is enough evidence that the therapy is effective, but the FDA does not yet agree that has been established. Then, in congruence with its policy on unproven medical procedures, the FDA has severely constrained stem cell procedures. > and it is autologous which has traditionally been an exempt area in this respect. It's clear that there was little/no enforcement in this area previously, but now they have announced clarification that it is to be enforced. You may call that a change in the regulatory environment, but it doesn't appear to be a change in general policy. The situation is very similar to 23andMe. 23andMe was flying under the radar and, when the FDA cracked down on them, they experienced a changed in their effective regulatory environment, but this is not reasonably interpreted as the FDA changing its tune (or overturning history or precedent or whatever). Again, I wish the FDA allowed more of these things to proceed (including 23andMe and stem cells) but I don't think this is change.

mgr86 10y ago

> MSC's have been shown to improve COPD 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?

willholloway 10y ago
There are clinics and doctors that have been performing the procedure, lowest cost I have seen is $7k for a treatment. They can harvest, isolate and deliver his own MSC via IV and perhaps nebulizer. It seems like the doctors that have been performing are silos of information right now. There is not a lot published on the web of their experience as practicing doctors, some of the best on the ground info I have found is from interviews of doctors practicing. There are also very many published MSC trials showing a benefit. It is a terrible thing to not be able to breathe well. I hope that this can help.
- mgr86 10y ago
  Thanks! I will try my best to look into this and hope he is willing. He doesn't talk about it much.

ancap 10y ago

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.

nbb 10y ago
So every con artist should be unrestricted in selling false hope to the most desperate of us?
- kafkaesq 10y ago
  Do you realize that this a straw man argument?
  - nbb 10y ago
    I don't realize that because it's not.
    - rhizome 10y ago
      It wasn't a strawman, but it was a pretty aggressive argument in bad faith.
      - marshray 10y ago
        You've never worked in a specialist medical clinic. Edit: not intended to sound ad hominem
        rhizome 10y ago
        a) How do you know? b) The phrase you're looking for is "argument from authority," which it is.

guelo 10y ago

If the cells are already in your body what's the point of extracting them just to reinject them back in?

smt88 10y ago
The cells are not injected into the same part of the body that they were extracted from.

rhizome 10y ago

Incredible post, thank you so much for a clear and concise overview.

Natsu 10y ago

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.

atomical 10y ago

What about androgenic alopecia? Is there potential there?

dataangel 10y ago

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).