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. ;)
Different therapies will likely require different numbers of cells, and most clinical trials using MSCs involve preliminary expansion of the cells. We store multiple aliquots of your cells so that only a portion may be thawed at a time.
We don't expand the cells at this time, but will likely offer expansion services in the future.
Yes, by expanding you could create a very large reserve of cells.
Hm, this will make me sounds like a smart-ass, but ever since I learned about stem cells I was wondering why one does what you do. I mean, in some fundamental way it's kind of obvious. If your cells get damaged with age, why not store young cells and reintroduce them later? I realize that this isn't nearly as simple as I described, but the fundamental concept intuitively makes sense.
I'm glad to hear about your company. And I'd kind of proud that my intuition proved correct, even though I don't know much about the field.
Can people from other countries use your service (by traveling to one of your locations?)
At what (maximum) age would the max potential benefit be achieved from harvesting? (ie, I assume it doesn't make sense for an infant to have this procedure, but assuming it's available throughout one's life, when would be the optimal time to do it?)
>Can people from other countries use your service (by traveling to one of your locations?)
Yes.
>At what (maximum) age would the max potential benefit be achieved from harvesting?
Functional data of cells harvested from donors of different ages shows much variability between individuals, but after about 40, a slow trend in decreased differentiation potential, proliferation, and other measures, appears. The decline depends upon the measure, but in general, suggests 20-40yo is the best window, and closer to 20 is likely better. The functional decline continues, but seems to get steeper around 60. Between 70-80, some studies report that the numbers of stem cells start to drop in addition to function. Here is a representative study: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2398731/
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.
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.
- you're using bone marrow stem cells and using the same confusing acronym as mesenchymal stem cells. As someone who has been out of active research for several years, what is the difference? And are there other acronyms that are accepted?
- BM stem cells through bone marrow harvest used to be the order of the day for repopulating immune systems following irradiation of marrow for some leukemias. Nowadays the state of the art is that those stem cells can be harvested by fractioning whole blood, so you only have the hassle of a blood donation, rather than the serious and not to be sneezed at act of penetrating cortex to harvest marrow. Is there any reason you can't get this from whole blood?
People often use 'marrow stromal cells' or 'mesenchymal stem cells' interchangeably as scientific terms (but of course, there is debate) that refer to adherent colony-forming multipotent cells. We use 'bone marrow stem cells' as a non-scientific term that includes MSCs as well as hematopoietic stem cells and endothelial stem cells.
>Is there any reason you can't get this from whole blood?
The blood harvest process uses a machine, takes a few hours, and requires the prior administration of a protein that stimulates stem cell proliferation and release into the blood. It is preferable for some procedures, but for those reasons, not for ours.
We are based in Ann Arbor, MI. We are currently opening operations in the Piedmont of NC, and CA (SF) will follow soon after. More cities after that.
If you are interested, contact us, and let us know where you are at.
The procedure is done with a local anesthetic. The entire procedure takes about 15 minutes from lying down to standing up. It is drawn from the upper part of your pelvis bone on your lower back. The most discomfort is a muscle cramp-like feeling that lasts about 5 seconds upon the draw itself. Personally, I rated it a 3.5 out of 10, as did my wife. Consensus is 3-4. Our CEO is a self-professed wimp, and he said it was a 4. :) I'd much prefer it to a cavity being filled. There is no recovery, just a bruise-like tenderness at that exact spot for a few days. I walked across town for lunch afterwards.
As mentioned in the article, transplanted MSCs have not been found to carry risk of tumor formation, and this is seen as one of their advantages.
Induced stem cells (IPS), or stem cells that are genetically modified may carry these risks, as there is overlap in the signaling mechanisms that maintain the undifferentiated state of stem cells, and that of tumor. In fact, stem cells naturally express more tumor-suppressing proteins as they age, which is thought to be a mechanism to prevent tumorigenesis resulting from damage accrued in the cells over time.
> 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.
> 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.
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.
When the original commenters said "Everyone, especially a chronically ill person on their deathbed, should be free to choose whatever experimental medical procedure they want", it's safe to assume he meant "within reason".
The "within reason" part is very important: As in, someone on their deathbed might have to go through certain hoops to get not-yet-approved treatment X (like signing waivers saying they understand the risks, etc); and there might other minimalist safeguards in place (such as that the chemicals are manufactured at regulated facilities; that the persons involved in administering the treatment have no criminal records or major fraud convictions against them) -- but ultimately, they can get access to treatment X.
By tweaking this to an extreme absolutist position -- "there should be no regulation of end-of-life treatments, of any kind, whatsoever; even if the person offering the trade is a convicted criminal and/ con-artist" you are standing up a false argument that the original commenter wasn't making.
thank you! fda is a leading cause of death in US in my opinion; from killing off inovation that would prevent death.
I worked at a medical startup that was bought by JNJ, it was high end surgery technolgy.
We made the first gen of our product, and it took 14 months to clear fda. Even though we made lots of improvments to the devices after, we never released them; that would have caused another horible fda clearance process.
I'm similarly lazy, but hopefully this paragraph captures some of the ideas:
> Caplan suggested that giving Josh the drug through the compassionate-use protocol might endanger its approval by the FDA. In the worst case, Josh would die after taking brincidofovir, and that outcome would “be held against the drug and the company until they can show the drug did not kill him.” In the meantime, other patients would find their access to the drug severely restricted. What’s more, an online campaign powered by photographs of a sick little boy raised hard questions about fairness. “Those who are not very cute get less attention in their pursuit of unproven drugs,” Caplan wrote. “If Josh had parents who did not understand how to use social media, he would already be out of luck.”
Interesting, but does that not highlight even more so the backwardness of the FDA? If they are willing to take some anecdotal case where someone died who happened to be taking a drug--blaming it on the drug company, despite the clinical research which had been done, further delaying their going to market--that doesn't sound like a compelling argument for the efficacy of the FDA in these cases.
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?
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.
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.
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.
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.
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...