Amniotic tissue products don't contain living cells...

IPSIS: Formerly the Spine Intervention Society
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This is why doctors, especially orthopedic surgeons, are perpetuating one of the biggest scams in medicine when offering "stem cell" injections to the shoulders, knees, spine, etc using these freeze dried sources with no live stem cells.
 
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Interesting...

But here are some other interesting articles (not posters)....

Koob, Thomas J., et al. "Biological properties of dehydrated human amnion/chorion composite graft: implications for chronic wound healing." International wound journal 10.5 (2013): 493-500.

Koob, T.J., J.J. Lim, M. Massee, et al., Properties of dehydrated human amnion/chorion composite grafts: Implications for wound repair and soft tissue regeneration. J Biomed Mater Res B Appl Biomater, 2014. 102(6): p. 1353-62.

Maan, Z.N., R.C. Rennert, T.J. Koob, et al., Cell recruitment by amnion chorion grafts promotes neovascularization. J Surg Res, 2015. 193(2): p. 953-62

Massee, M., K. Chinn, J. Lei, et al., Dehydrated human amnion/chorion membrane regulates stem cell activity in vitro. J Biomed Mater Res B Appl Biomater, 2015.

Massee, M., K. Chinn, J.J. Lim, et al., Type I and II diabetic adipose derived stem cells respond in vitro to dehydrated human amnion/chorion membrane allograft treatment by increasing proliferation, migration, and altering cytokine secretion. Adv Wound Care, 2015.

Koob, TJ; Lim, JJ; Massee, M; Zabek, N; Rennert, R; Gurtner, G; Li, WW. “Angiogenic Properties of Dehydrated Human Amnion/Chorion Allografts: Therapeutic Potential for Soft Tissue Repair and Regeneration.” Vascular Cell. 2014;6:10.
 
Outside of the overt fraud being committed by doctors that tell their patients they are being given stem cells when in fact they are not, are there any good randomized studies showing positive outcomes in humans or is this $2000-$6000 treatment just hopeful medicine? In such cases are patients being told the degree of scientific support (or lack thereof) that exists to support such treatments?
 
so Ovation Repair Cellular Matrix does have cells?
 
algosdoc said:
This is why doctors, especially orthopedic surgeons, are perpetuating one of the biggest scams in medicine when offering "stem cell" injections to the shoulders, knees, spine, etc using these freeze dried sources with no live stem cells.
Click to expand...

Original thought process for using amniotic products was that it improved the mechanical properties of the joint, not that "stem cells" were involved
Shimberg M. The use of amniotic-fluid concentrate in orthopaedic conditions. Journal of Bone and Joint Surgery. 1938;20(1):167-177
not sure what you're getting at here

Gelhorn has a new case study coming out:
http://www.pmrjournal.org/article/S1934-1482(16)31283-7/fulltext
 
What I am getting at is that patients are being told by their doctors they are getting stem cell therapy or stem cells when they are not. It doesn't matter the mechanism of action- what matters is that the doctors are defrauding people by using the schtick of stem cells in order to lure people into a therapy that has nothing to do with stem cells. It is called lying. Fraud. Misrepresentation. It is also illegal, even if no insurer or government program is involved. The crime of larceny applies to a person who, with intent to deprive another of his property, obtains, takes or withholds the property by means of trick, embezzlement, false pretense, false promise, including a scheme to defraud, or other similar behavior. Grand larceny is a felony, in different degrees depending on the amount of money involved.
 
Gauss said:
Original thought process for using amniotic products was that it improved the mechanical properties of the joint, not that "stem cells" were involved
Shimberg M. The use of amniotic-fluid concentrate in orthopaedic conditions. Journal of Bone and Joint Surgery. 1938;20(1):167-177
not sure what you're getting at here

Gelhorn has a new case study coming out:
http://www.pmrjournal.org/article/S1934-1482(16)31283-7/fulltext
Click to expand...

3 mo follow up. Lame. Why bother allowing this in journal. Get 12 mo data min.
 
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algosdoc said:
What I am getting at is that patients are being told by their doctors they are getting stem cell therapy or stem cells when they are not. It doesn't matter the mechanism of action- what matters is that the doctors are defrauding people by using the schtick of stem cells in order to lure people into a therapy that has nothing to do with stem cells. It is called lying. Fraud. Misrepresentation. It is also illegal, even if no insurer or government program is involved. The crime of larceny applies to a person who, with intent to deprive another of his property, obtains, takes or withholds the property by means of trick, embezzlement, false pretense, false promise, including a scheme to defraud, or other similar behavior. Grand larceny is a felony, in different degrees depending on the amount of money involved.
Click to expand...

Welcome to medicine. I've seen FP's give antibiotics to viral symptoms. Total Fraud. I've seen spine surgeons fuse patients for back pain. Total fraud.

I don't think this is so much more fraudulent then many things we tell our patients. And I suspect if physicians are saying this, maybe they believe it.

I know (based on the articles I linked above) that AmnioFix doesn't contain stem cells, but it certainly attracts a tremendous amount of stem cells to the area after injection - so in a way...yes, it IS stem cell therapy. I make this very clear to them - that AmnioFix doesn't contain stem cells, but it attracks the patient's own stem cells. How is that not stem cell therapy?
 
Because it is inaccurate. Stem cell therapy is the injection of stem cells in order to achieve an effect. Augmentation of stem cells is speculative since in humans we have no idea of the degree of this effect, if any, nor whether any such effect is clinically relevant. Does it make a difference in human outcome or is there another effect occurring that would be just as logical explanation? Remember all drugs may not be effective....for instance epidural saline injections may be just as effective as glucocorticoid injections. But you are giving informed consent to your patients- spine surgeons clearly are not since i have a large number of patients in my practice that indeed believe the had stem cells injected when they did not.

Sent from my SM-G930U using SDN mobile
 
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cord blood is supposed to be the "better" tissue for higher about of signaling cells that are viable vs amnio or placental due to lack of viable cells. Also because these manufacturers say they have susch and such no of cell does not mean they are actually "VIABLE CELLS" so its important to look at how they quantified these no of cells. Was the tissue rehydrated and grown invitro then counted. Or did they just count the cells in the dehydrate frozen tissue sample which contain all DEAD cell which are completely NOT VIABLE. Its tricky sorting this out.
 
epidural man said:
Welcome to medicine. I've seen FP's give antibiotics to viral symptoms. Total Fraud. I've seen spine surgeons fuse patients for back pain. Total fraud.

I don't think this is so much more fraudulent then many things we tell our patients. And I suspect if physicians are saying this, maybe they believe it.

I know (based on the articles I linked above) that AmnioFix doesn't contain stem cells, but it certainly attracts a tremendous amount of stem cells to the area after injection - so in a way...yes, it IS stem cell therapy. I make this very clear to them - that AmnioFix doesn't contain stem cells, but it attracks the patient's own stem cells. How is that not stem cell therapy?
Click to expand...

interesting rationale.

True that much of what we do in medicine has meager evidence.
 
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Doctodd said:
Yea just read that.....who pissed in Centeno's corn flakes?
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We've got several chiropractic clinics that advertise stem cell therapy and charge 5 to $10,000. We have an elderly population that doesn't know better. The same chiropractors also offer weight loss and treatment for diabetes. They buy you a free dinner at Ruth's Chris Steak House to coax you in
 
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lobelsteve said:
We've got several chiropractic clinics that advertise stem cell therapy and charge 5 to $10,000. We have an elderly population that doesn't know better. The same chiropractors also offer weight loss and treatment for diabetes. They buy you a free dinner at Ruth's Chris Steak House to coax you in
Click to expand...

Combat health fraud with education. It would be great if SIS, AAPMR, ASIPP, IOF, NASS, and other specialty societies making money on Regen Med CME activities would kick a little of that back toward patient safety, education, and fraud prevention activities.

https://www.bizjournals.com/portlan...egon-patients-should-beware-of-stem-cell.html
 
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lobelsteve said:
We've got several chiropractic clinics that advertise stem cell therapy and charge 5 to $10,000. We have an elderly population that doesn't know better. The same chiropractors also offer weight loss and treatment for diabetes. They buy you a free dinner at Ruth's Chris Steak House to coax you in
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Ruth's Chris? I'd go for that.

In my area they usually offer Golden Corral. Haha!
 
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14995408894991308531713.jpg
 
Does anyone have an update from TOBI and Wenchun Qu's research on intradiscal BMAC for DDD. Ongoing study but not sure if there was talk of this or not in Vegas.
 
lobelsteve said:
We've got several chiropractic clinics that advertise stem cell therapy and charge 5 to $10,000. We have an elderly population that doesn't know better. The same chiropractors also offer weight loss and treatment for diabetes. They buy you a free dinner at Ruth's Chris Steak House to coax you in
Click to expand...

Yea but I don't recall him ever taking on a large multi center group like that one. Crazy that a Chiro can own such a large operation.
 
chiro giving one of the talks....seems legit

Stem Cells for DDD
Degenerative cascade for DDD
New imaging modalities o Preclinical data
Clinical data
W. Mark Erwin, DC, PhD
 
Doctodd said:
chiro giving one of the talks....seems legit

Stem Cells for DDD
Degenerative cascade for DDD
New imaging modalities o Preclinical data
Clinical data
W. Mark Erwin, DC, PhD
Click to expand...

hey, but the guy is a PhD. it must be legit!
 
Ligament said:
How FDA Plans to Help Consumers Capitalize on Advances in Science | FDA Voice
Click to expand...

"Our Center for Biologics Evaluation and Research (CBER) is implementing the Regenerative Medicine Advanced Therapy, or RMAT designation. This new process provides another pathway to access FDA’s existing expedited programs, and is available for certain cell therapies, therapeutic tissue engineering products, and certain combination products. The goal of these efforts is to help foster the development and approval of these novel products. We’ve already received almost two dozen requests for RMAT designation and granted four such designations to date. To continue to advance these opportunities, we’ll be announcing this September a comprehensive framework for the development and proper FDA oversight of regenerative medicine. This new policy effort will comprise a series of new guidance documents covering many aspects of the regulation of regenerative medicine products. It will be announced as part of our Innovation Initiative. It will delineate our policies for appropriate and efficient regulatory oversight of regenerative medicine products, in order to demonstrate their safety and effectiveness. It will also create an accessible framework that will enable providers to more easily collaborate on proving these principles for regenerative products that are advanced within local medical institutions. We want to help facilitate these scientific advances, which hold out tremendous potential for treating and even curing diseases. To achieve these goals, we need to make sure that we have a modern regulatory framework in place that can allow innovators to meet the statutory requirements for demonstrating safety and effectiveness."

...taken at face value, there's never been a more important time than NOW for stakeholders in the Pain, Spine, and Interventional Ortho realm to step up to the plate...
 
Ligament said:
https://www.regenexx.com/stem-cell-institute-america-plot-thickens/
Click to expand...

Centrino is creating a straw man - I think.

I am a huge supporter of AmnioFix (a chorion/amnion product) - mostly because they have very good science behind their EpiFix product and seem to be doing honest science and doing their best to leave pseudo-science behind. (For more on this, see their primer titled "A primer on Amniotic Membrane Regenerative Healing" which I have a digital copy and can send to anyone asking...too big to attach.) They say, all over their printed material, that their product DOES NOT contain live cells. Yet Centrino makes it seem like the product is "not what it seems" and all that crap by creating a straw man argument.

However, if practitioners are CLAIMING that AmnioFix contains live cells, you can't blame the company for that. But you also can't then discredit the product because others are not telling the truth about it either.
 
Had a patient today. Muay Thai fighter. Got intradiscal stem cell injection in Vegas 4 months ago. New onset radic and same low back pain.

Got a fu MRI to check for discitis. Unchanged from MRI prior to stem cell.

Ask me five different ways why his MRI hadn't changed and the annular tear hadn't healed.... couldn't get his head around it. Believed in it so badly.

No one know if the 1stem cell per billion cells in bmac does anything. None of the negative studies by the docs with their hands in the cookie jars will ever get published.

I think regenerative medicine is an exciting frontier but like most other miracles in medicine the odds are it doesn't work.
 
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nvrsumr said:
Had a patient today. Muay Thai fighter. Got intradiscal stem cell injection in Vegas 4 months ago. New onset radic and same low back pain.

Got a fu MRI to check for discitis. Unchanged from MRI prior to stem cell.

Ask me five different ways why his MRI hadn't changed and the annular tear hadn't healed.... couldn't get his head around it. Believed in it so badly.

No one know if the 1stem cell per billion cells in bmac does anything. None of the negative studies by the docs with their hands in the cookie jars will ever get published.

I think regenerative medicine is an exciting frontier but like most other miracles in medicine the odds are it doesn't work.
Click to expand...

Way Yin published his negative study.
I believe we talked about depalma paper with results not appearing as rosy as conclusions.
 
nvrsumr said:
Had a patient today. Muay Thai fighter. Got intradiscal stem cell injection in Vegas 4 months ago. New onset radic and same low back pain.

Got a fu MRI to check for discitis. Unchanged from MRI prior to stem cell.

Ask me five different ways why his MRI hadn't changed and the annular tear hadn't healed.... couldn't get his head around it. Believed in it so badly.

No one know if the 1stem cell per billion cells in bmac does anything. None of the negative studies by the docs with their hands in the cookie jars will ever get published.

I think regenerative medicine is an exciting frontier but like most other miracles in medicine the odds are it doesn't work.
Click to expand...
Duh.

Stem cells die after injection. Engraftment is a real issue.

You're better off injection something that is dead already - that moderates and accelerates angiogenisis and tissue rebuilding/remodeling (I'm not paid by AmnioFix, but dammet - I should be!)
 
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Always thought provoking...beware of salespeople selling vials of magic potions...

https://www.regenexx.com/regen-america-review/

The stem cell wild west gets worse every month. This past year, we’ve seen the entry of chiropractic groups offering stem cell therapies, representing a paradigm shift in the treatment of orthopedic injuries. As a result, the hyperbole factor and targeting of the elderly has increased. Today I’d like to perform a review on Regen America, one such chiropractic stem cell group.
 
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once it becomes the purview of chiropractic care, the likelihood that it will become evidence based useful medical practice in the future markedly diminishes...
 
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Ducttape said:
once it becomes the purview of chiropractic care, the likelihood that it will become evidence based useful medical practice in the future markedly diminishes...
Click to expand...

Only if you allow it....only if we allow it.....by remaining silent and discrediting our colleagues instead of helping them. Plenty of orthos in on this as well
 
the chiropractors arent injecting on their own. they need docs to do the actual procedure (i think). this really is a MEDICINE issue, not a chiro issue.
 
SSdoc33 said:
the chiropractors arent injecting on their own. they need docs to do the actual procedure (i think). this really is a MEDICINE issue, not a chiro issue.
Click to expand...

The biz model is to hire/employ CRNA's or NP's and use them as injection techs. I'm sure that there are MD/DO's involved in these schemes which I think is disgusting. The people perpetuating this kind of health fraud are filthy.
 
drusso said:
The biz model is to hire/employ CRNA's or NP's and use them as injection techs. I'm sure that there are MD/DO's involved in these schemes which I think is disgusting. The people perpetuating this kind of health fraud are filthy.
Click to expand...

A Chiro friend of mine brought his mom to me.....80 y/o woman who still worked 8-12 hour shifts at Macy's on her feet. She did great and kept working. Shortly thereafter I saw he started doing some type of PRP/MSC with an aRNP in his office.
 
comparison of PRP and amniotic
 

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Wenchun Qu gave another talk at AAPM this week... he is beating the drum for science behind stem cells and other biologics, but isn’t promising moonbeams and rainbows with BMAC, so all the guys excited to sign up for a year of “fellowship” with companies selling this to patients left and right (not naming names) roll their eyes when the focus is on research, and what is/isn’t known. I like that this forum seems to be concerned with evidence based medicine - and honest about what works, what doesn’t.

What we know is that MSCs (especially in the minimally manipulated, autologous, point of care form offered today) are safe. (Of course as long as procedures are performed competently.) What isn’t known is long term efficacy. Agree that we need long term follow up, prospective, randomized controlled studies taking a closer look, and standardized recommendations regarding doses and parameters (esp for PRP products). Maybe products that are culture expanded and genetically modified - not yet ready for prime time - will hold more promise. But good, unbiased research takes time and resources. Hopefully there is patience for studies, and there won’t be too many people doing unsafe procedures (think injecting fat into eyeballs) to muck up the investigative process.
 
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LoveMyBuckeye said:
But good, unbiased research takes time and resources. Hopefully there is patience for studies, and there won’t be too many people doing unsafe procedures (think injecting fat into eyeballs) to muck up the investigative process.
Click to expand...

The problem is that the people doing the "unbiased" research aren't always "content experts" in the field they're researching. While they may not have financial COI's, they usually have ideological COI's or have jobs that depend upon publishing research for career advancement and salary increases. Usually, they're "health service utilization" experts. So, using poorly adapted tools of applied social science and meta-analysis, these "experts" often don't find results because they are mixing "apples and oranges."

https://www.regenexx.com/meta-analysis-blood-products-achilles-tendinopathy/

"My concern with this study is that policymakers who don’t understand the differences in blood products that I’ve described above won’t look at this new meta-analysis critically. They may not understand why it’s a garbage study. In the meantime, now you understand a little about how a meta-analysis works and also how different PRP treatment preps can impact healing in different ways!"

Big Data: The Danger in Knowing Less and Less about More and More | The Lund Report

"Thus, the real danger of meta-analysis is putting a premature end to a discussion based upon biased interpretation cloaked in quantitative authority. Contrary to the ideal of policymakers carefully weighing all evidence on complex issues before making rules and allocating resources, all too often policymakers have used research politically, selectively drawing on evidence to support already held views."
 
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Stem cells injections as they are practiced in the US are the wet dreams of tort attorneys. It will be interesting to see when the explosion of litigation cases will occur and when attorney generals will start fraud proceedings against those promising the moon or as an inducement into human experimentation...e.g. "stem cells have been used for.....x, therefore we offer stem cell therapy for you"
 
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