NYT: Stem Cell Treatments Flourish Despite Evidence

[SommeRiver]

I wonder if we will ever have good answers in the chronic pain realm.

Think about this. Ten patients have shoulder pain, all with rotator cuff tears. One patient hurts because of a nociceptive and inflamed bursa, and the other have pain because of moms with fibro, they tend to catastrophize everything, business is failing, and some just found out their son wants to transition. Now add a treatment that is legit and works for inflamed bursa extremely well. Would we every be able to figure that out? I doubt it.

I agree with you, and this example is exactly the reason that pain...which is by definition an emotional experience...will always be sort of fringey relative to most other specialties. Art of medicine and bedside manner IMO.

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[Ducttape]

That is an indictment as to the waste of medical dollars spent on interventional therapy, compared to focusing more on the psyche, since injections cost much more than pain psychology...

 

[SommeRiver]

That is an indictment as to the waste of medical dollars spent on interventional therapy, compared to focusing more on the psyche, since injections cost much more than pain psychology...

Pain psychology only works if the pt will go regularly and they take it seriously, and while you or I would definitely go if we were a chronic pain pt your avg American simply isn't gonna do it. Modern society with social media and immediate gratification demands? Not to mention it isn't as simple as just making a referral like you would to a urologist or a pulmonologist. I was sending ppl to a pain psych guy who I later found out was doing over the phone visits, and was doing them while grocery shopping. My fellowship was at a major pain psych institution and I simply wasn't impressed by it.

 

[GH253]

That is an indictment as to the waste of medical dollars spent on interventional therapy, compared to focusing more on the psyche, since injections cost much more than pain psychology...

Just what pain sufferers need, to be dismissed as crazies and patronized by mental health professionals who have no evidence behind anything they do.

 

[callmeanesthesia]

Just what pain sufferers need, to be dismissed as crazies and patronized by mental health professionals who have no evidence behind anything they do.

You’re right, pain is a totally physical phenomenon. The mind and mental health play no role. Since it’s so objectively measurable, it should probably be a vital sign or something shouldn’t it?

 

[Ducttape]

Just what pain sufferers need, to be dismissed as crazies and patronized by mental health professionals who have no evidence behind anything they do.

and narcotics and marijuana are solving the problem as we post.

 

[GH253]

and narcotics and marijuana are solving the problem as we post.

Regenerative medicine is making the first inroads toward treating the causes of pain and all some people can do is talk it down and hope it fails just because it supplants what they were taught.

 

[Aether2000]

If regenerative medicine= stem cells for Alzheimers, macular degeneration, and MS without scientific and medical proof, delivered in outpatient clinics for $15,000 a pop, then I would brand this as human experimentation and so does the FDA. If regenerative medicine= stem cells delivered from dead cells acquired from amnionic tissue and there is no medical and scientific proof of efficacy, then yes, I hope it fails to put out of business all the flim flam surgeons who have used this over the past 6 years in their patients, and hope their medical license is at risk. If regenerative medicine is use of stem cells for knees with appropriate selection criteria and patients are given the data published showing reduction in pain both short and long term and the known risks before coughing up $5 grand, then yes, that is appropriate use of regenerative medicine.

 

[drusso]

Pain psychology only works if the pt will go regularly and they take it seriously, and while you or I would definitely go if we were a chronic pain pt your avg American simply isn't gonna do it. Modern society with social media and immediate gratification demands? Not to mention it isn't as simple as just making a referral like you would to a urologist or a pulmonologist. I was sending ppl to a pain psych guy who I later found out was doing over the phone visits, and was doing them while grocery shopping. My fellowship was at a major pain psych institution and I simply wasn't impressed by it.

I've been offering chronic pain patients integrated behavioral health and substance use treatment for eight years. It started with me and my partner opening up our wallets and sinking money and resources into it to get it going. I've never seen it done before in private practice interventional pain. Eight years later it is still a money loser. The reimbursement s*cks ****.

It is not the solution most people think it is, but for SOME patients it is a life-saver.

 

[SommeRiver]

I've been offering chronic pain patients integrated behavioral health and substance use treatment for eight years. It started with me and my partner opening up our wallets and sinking money and resources into it to get it going. I've never seen it done before in private practice interventional pain. Eight years later it is still a money loser. The reimbursement s*cks ****.

It is not the solution most people think it is, but for SOME patients it is a life-saver.

Yes. Also to say that pain psych is much cheaper than an occasional injxn just isn't true. IF you can convince a pt to go they will be paying for those visits. Reimbursement sucks and frequently the psychologist doesn't take insurance and it is like $150 a visit, and you have to go all the time.

 

[Ducttape]

an office visit at $150 a pop (which is 2 1/2 times more than Medicare rate) is 2 1/2 times less expensive than a lumbar epidural injection done by a non-employed physician at an in network ASC. its also about 80 times less expensive than that $5000 PRP injection...

the rest of your post suggests what we should be doing in terms of public perception - change the societal norms and mores of the average American mindset to be more in line with the rest of the world. for chronic pain, no miracle cures. and the patient actually needs to make an actual commitment to get better or be accepting that s/he will have chronic pain.

 

[SommeRiver]

an office visit at $150 a pop (which is 2 1/2 times more than Medicare rate) is 2 1/2 times less expensive than a lumbar epidural injection done by a non-employed physician at an in network ASC. its also about 80 times less expensive than that $5000 PRP injection...

the rest of your post suggests what we should be doing in terms of public perception - change the societal norms and mores of the average American mindset to be more in line with the rest of the world. for chronic pain, no miracle cures. and the patient actually needs to make an actual commitment to get better or be accepting that s/he will have chronic pain.

I agree with your second paragraph absolutely, but your first isn't my experience. If you pay cash for an epidural with us it is like $600. You don't go to Pain Psych once, you go repeatedly for weeks and weeks.

Your suggestion that my quote of $150 being 2.5 Medicare is the point exactly, and that's the reason psychologists so often refuse insurance. You're going to keep your lights on with Medicare? No, you're going to charge cash or accept a few select insurance companies and pray to God the pt will keep seeing you bc their doctor told them to...

Edit - The public perception statement I couldn't agree with more dude. I tell just about every pt of mine to expect good days and bad days, and mild to moderate pain. If it gets severe we can stick you with a needle, do more PT, try new meds, etc...but you haven't died yet so your multilevel stenosis and facet disease will not go away. No one can make it go away, but it doesn't have to for you to feel better and have a high QoL.

 

[drusso]

an office visit at $150 a pop (which is 2 1/2 times more than Medicare rate) is 2 1/2 times less expensive than a lumbar epidural injection done by a non-employed physician at an in network ASC. its also about 80 times less expensive than that $5000 PRP injection...

the rest of your post suggests what we should be doing in terms of public perception - change the societal norms and mores of the average American mindset to be more in line with the rest of the world. for chronic pain, no miracle cures. and the patient actually needs to make an actual commitment to get better or be accepting that s/he will have chronic pain.

If a $5,000 PRP injection (never seen a such a thing) staves off a $10,000 arthroscopy for just 5 years; it's a winner every time just on the SOS arbitrage alone. Not even counting loss time from work, PT, potential procedural complications, etc.

 

[Ducttape]

But that is almost impossible to quantify. And it is the same argument that has not really worked for epidurals.

I used to tell ppl “we will do this injection so that you won’t need surgery”, but generally there is no logical conclusion, as enough ppl will get the epidural, not get enough relief, and be convinced they have to have surgery.

Now I tell them the injection will help with the pain while you work on improving functionality and CBT to improve quality of life and don’t get screwed (literally) because in 5 years you’ll be right back here, but with screws...

 

[drusso]

But that is almost impossible to quantify.

It's being documented and quantified as we speak...

Procedural Comparison

regenexxcorporate.com

 

[drusso]

But that is almost impossible to quantify. And it is the same argument that has not really worked for epidurals.

I used to tell ppl “we will do this injection so that you won’t need surgery”, but generally there is no logical conclusion, as enough ppl will get the epidural, not get enough relief, and be convinced they have to have surgery.

Now I tell them the injection will help with the pain while you work on improving functionality and CBT to improve quality of life and don’t get screwed (literally) because in 5 years you’ll be right back here, but with screws...

"I have yet to see a single bench scientist admit that he or she is only offering one opinion in an academic debate. In the same way, I have yet to see a single story on orthobiologics where the journalist has sourced opinions from both sides of campus."

do bench scientists have an ethical duty to report that their point of view is not the only one

Advanced regenerative orthobiologic injection treatments for injuries, arthritis, athletes & more. Regenexx is the trusted alternative to surgery.

regenexx.com

 

[Ducttape]

no offense... but quoting position papers from a company who essentially is stem cell therapy is kinda like, well, asking BP or Exxon if gasoline is good for the environment... or Marlboro if the cigarettes they sell will cause their smokers to die.


as to your other point, the article makes a fatal flaw in their argument. to wit: "bench scientists are now merely offering an opinion in a debate with two sides. Hence, they now have an ethical duty to the public to inform journalists that their opinion is merely one opinion that would be opposed by other academic professors."

no, bench scientists are supposed to look at the science and the results of scientific research.

they do not offer an opinion. they are supposed to offer a hypothesis or theory based on the available data. completely different from an "opinion", and to say so belittles their work.

 

[Doctodd]

can u stop saying plain PRP injections are $5000?

 

[lobelsteve]

can u stop saying plain PRP injections are $5000?

$4499 with coupon.

 

[emd123]

I wonder how many are putting steroid and/or visco in their prp/stem cell injections. That way the patient actually gets some relief for a period of time and psychologically feels "It worked, but just didn't last. I guess I am just too bad off and need the surgery." That way the doc can claim at least they got some relief for their $5,000, but "The shot worked but your OA is worse than I thought. You do need a knee replacement."

Is that how the scam is done?

 

[drusso]

I wonder how many are putting steroid and/or visco in their prp/stem cell injections. That way the patient actually gets some relief for a period of time and psychologically feels "It worked, but just didn't last. I guess I am just too bad off and need the surgery." That way the doc can claim at least they got some relief for their $5,000, but "The shot worked but your OA is worse than I thought. You do need a knee replacement."

Is that how the scam is done?

Someone presented a paper about this at IOF...some have found effects, others not.

J Biol Regul Homeost Agents. 2019 Mar-Apr;33(2 Suppl. 1):21-28.
The combined use of platelet rich plasma and hyaluronic acid: prospective results for the treatment of knee osteoarthritis.
XIX CONGRESSO NAZIONALE S.I.C.O.O.P. SOCIETA' ITALIANA CHIRURGHI ORTOPEDICI DELL'OSPEDALITA' PRIVATA ACCREDITATA, Papalia R1, Zampogna B1, Russo F1, Torre G1, De Salvatore S1, Nobile C2, Tirindelli MC2, Grasso A3, Vadalà G1, Denaro V1.
Author information

Abstract
Osteoarthritis represents an important social economic burden with a high incidence worldwide. Conservative management of knee OA consists in several therapeutic options: pharmacologic therapy such as analgesics, non-steroid and steroid anti-inflammatory drugs, physical therapy, and injective therapy with hyaluronic acid (HA) and platelet-rich plasma injections (PRP). The aim of our study is to evaluate the effect of combined autologous PRP and HHA (Hybrid Hyaluronic Acid) viscosupplementation on clinical outcomes of patients with knee OA, by assessing the subjects before and after injective treatment. The study was conducted on 60 patients with an age between 40 and 70 years old affected by unilateral symptomatic knee osteoarthritis (stage II and III of Kellgren-Lawrence scale) nonresponsive to pharmacologic and rehab treatment. We divided the patients in two groups, and we treated the group A with injection of HHA and group B with HHA+PRP. Each patient received 3 injections at an interval of 1 week for 3 consecutive weeks. The patients were evaluated by the Knee Injury and Osteroartrhitis Outcome Score (KOOS) and Visual Analog Scale (VAS) at 3, 6 and 12 months after treatment. Statistical comparison between groups showed a significantly better result for the group B concerning the KOOS value, at 3 months and at 6 months. This difference, although clinically relevant, lost the statistical significance at 12 months. The VAS trend differently showed a significant difference at 3 and 12 months, while at 6 months the superiority of group B did not achieve statistical significance. Few studies investigated the effects of HA+PRP combined treatment for knee OA. Numerous studies demonstrated the efficacy of HA injection therapy in knee OA for a clinical point of view, reducing the pain and improving the quality of life. PRP preparations also improved functional outcome scores compared to hyaluronic acidand placebo in patients affected by knee OA. Based on our results we can conclude that the combined PRP and HHA treatment is not only a safe and efficacious procedure which can provide functional benefit but is also significantly better than HHA injective therapy alone, as demonstrated by the comparison within our cohort.
KEYWORDS:
combined treatment; hyaluronic acid; intra-articular injection; knee osteoarthritis; platelet-rich plasma


Am J Sports Med. 2017 Feb;45(2):339-346. doi: 10.1177/0363546516665809. Epub 2016 Oct 21.
Hyaluronic Acid Versus Platelet-Rich Plasma: A Prospective, Double-Blind Randomized Controlled Trial Comparing Clinical Outcomes and Effects on Intra-articular Biology for the Treatment of Knee Osteoarthritis
Cole BJ1,2,3,4,5, Karas V6, Hussey K1, Pilz K1,5, Fortier LA7.
Author information

Erratum in

• Corrigendum. [Am J Sports Med. 2017]

Abstract
BACKGROUND:
The use of platelet-rich plasma (PRP) for the treatment of osteoarthritis (OA) has demonstrated mixed clinical outcomes in randomized controlled trials when compared with hyaluronic acid (HA), an accepted nonsurgical treatment for symptomatic OA. Biological analysis of PRP has demonstrated an anti-inflammatory effect on the intra-articular environment.
PURPOSE:
To compare the clinical and biological effects of an intra-articular injection of PRP with those of an intra-articular injection of HA in patients with mild to moderate knee OA.
STUDY DESIGN:
Randomized controlled trial; Level of evidence, 1.
METHODS:
A total of 111 patients with symptomatic unilateral knee OA received a series of either leukocyte-poor PRP or HA injections under ultrasound guidance. Clinical data were collected before treatment and at 4 time points across a 1-year period. Synovial fluid was also collected for analysis of proinflammatory and anti-inflammatory markers before treatment and at 12 and 24 weeks after treatment. Several measures were used to assess results: (1) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale; (2) International Knee Documentation Committee (IKDC) subjective knee evaluation, visual analog scale (VAS) for pain, and Lysholm knee score; and (3) difference in intra-articular biochemical marker concentrations.
RESULTS:
There were 49 patients randomized to treatment with PRP and 50 randomized to treatment with HA. No difference was seen between the groups in the primary outcome measure (WOMAC pain score). In the secondary outcome measure, linear contrasts identified a significantly higher IKDC score in the PRP group compared with the HA group at 24 weeks (mean ± standard error [SE], 65.5 ± 3.6 vs 55.8 ± 3.8, respectively; P = .013) and at final follow-up (52 weeks) (57.6 ± 3.37 vs 46.6 ± 3.76, respectively; P = .003). Linear contrasts also identified a statistically lower VAS score in the PRP group versus the HA group at 24 weeks (mean ± SE, 34.6 ± 3.24 vs 48.6 ± 3.7, respectively; P = .0096) and 52 weeks (44 ± 4.6 vs 57.3 ± 3.8, respectively; P = .0039). An examination of fixed effects showed that patients with mild OA and a lower body mass index had a statistically significant improvement in outcomes. In the biochemical analysis, differences between groups approached significance for interleukin-1β (mean ± SE, 0.14 ± 0.05 pg/mL [PRP] vs 0.34 ± 0.16 pg/mL [HA]; P = .06) and tumor necrosis factor α (0.08 ± 0.01 pg/mL [PRP] vs 0.2 ± 0.18 pg/mL [HA]; P = .068) at 12-week follow-up.
CONCLUSION:
We found no difference between HA and PRP at any time point in the primary outcome measure: the patient-reported WOMAC pain score. Significant improvements were seen in other patient-reported outcome measures, with results favoring PRP over HA. Preceding a significant difference in subjective outcomes favoring PRP, there was a trend toward a decrease in 2 proinflammatory cytokines, which suggest that the anti-inflammatory properties of PRP may contribute to an improvement of symptoms. Registration: ClinicalTrials.gov (Identifier: NCT02588872).

 

[lobelsteve]

Those studies kinda show it doesn’t work.

 

[drusso]

Those studies kinda show it doesn’t work.

The only place I've seen any synergy is in the femoracetabular joint with autologous alpha-2-macroglobulin, not PRP.

Phys Med Rehabil Clin N Am. 2016 Nov;27(4):909-918. doi: 10.1016/j.pmr.2016.06.008.
α2-Macroglobulin: Autologous Protease Inhibition Technology.
Cuéllar JM1, Cuéllar VG2, Scuderi GJ3.
Author information

Abstract
α2-Macroglobulin (A2M) is a plasma glycoprotein best known for its ability to inhibit a broad spectrum of serine, threonine, and metalloproteases as well as inflammatory cytokines by a unique bait-and-trap method. A2M has emerged as a unique potential treatment of cartilage-based pathology and inflammatory arthritides. This article describes the unique method by which A2M not only inhibits the associated inflammatory cascade but also disrupts the catabolic process of cartilage degeneration. Autologous concentrated A2M from plasma is currently in use to successfully treat various painful arthritides. Future directions will focus on recombinant variants that enhance its anti-inflammatory and disease-modifying potential.
Copyright © 2016 Elsevier Inc. All rights reserved.
KEYWORDS:
Anti-inflammatory; Arthritis; Autologous; Cytokines; Discogenic back pain; Inflammation; Osteoarthritis; α(2)-macroglobulin (A2M)

 

[deleted993114]

Someone presented a paper about this at IOF...some have found effects, others not.

J Biol Regul Homeost Agents. 2019 Mar-Apr;33(2 Suppl. 1):21-28.
The combined use of platelet rich plasma and hyaluronic acid: prospective results for the treatment of knee osteoarthritis.
XIX CONGRESSO NAZIONALE S.I.C.O.O.P. SOCIETA' ITALIANA CHIRURGHI ORTOPEDICI DELL'OSPEDALITA' PRIVATA ACCREDITATA, Papalia R1, Zampogna B1, Russo F1, Torre G1, De Salvatore S1, Nobile C2, Tirindelli MC2, Grasso A3, Vadalà G1, Denaro V1.
Author information

Abstract
Osteoarthritis represents an important social economic burden with a high incidence worldwide. Conservative management of knee OA consists in several therapeutic options: pharmacologic therapy such as analgesics, non-steroid and steroid anti-inflammatory drugs, physical therapy, and injective therapy with hyaluronic acid (HA) and platelet-rich plasma injections (PRP). The aim of our study is to evaluate the effect of combined autologous PRP and HHA (Hybrid Hyaluronic Acid) viscosupplementation on clinical outcomes of patients with knee OA, by assessing the subjects before and after injective treatment. The study was conducted on 60 patients with an age between 40 and 70 years old affected by unilateral symptomatic knee osteoarthritis (stage II and III of Kellgren-Lawrence scale) nonresponsive to pharmacologic and rehab treatment. We divided the patients in two groups, and we treated the group A with injection of HHA and group B with HHA+PRP. Each patient received 3 injections at an interval of 1 week for 3 consecutive weeks. The patients were evaluated by the Knee Injury and Osteroartrhitis Outcome Score (KOOS) and Visual Analog Scale (VAS) at 3, 6 and 12 months after treatment. Statistical comparison between groups showed a significantly better result for the group B concerning the KOOS value, at 3 months and at 6 months. This difference, although clinically relevant, lost the statistical significance at 12 months. The VAS trend differently showed a significant difference at 3 and 12 months, while at 6 months the superiority of group B did not achieve statistical significance. Few studies investigated the effects of HA+PRP combined treatment for knee OA. Numerous studies demonstrated the efficacy of HA injection therapy in knee OA for a clinical point of view, reducing the pain and improving the quality of life. PRP preparations also improved functional outcome scores compared to hyaluronic acidand placebo in patients affected by knee OA. Based on our results we can conclude that the combined PRP and HHA treatment is not only a safe and efficacious procedure which can provide functional benefit but is also significantly better than HHA injective therapy alone, as demonstrated by the comparison within our cohort.
KEYWORDS:
combined treatment; hyaluronic acid; intra-articular injection; knee osteoarthritis; platelet-rich plasma


Am J Sports Med. 2017 Feb;45(2):339-346. doi: 10.1177/0363546516665809. Epub 2016 Oct 21.
Hyaluronic Acid Versus Platelet-Rich Plasma: A Prospective, Double-Blind Randomized Controlled Trial Comparing Clinical Outcomes and Effects on Intra-articular Biology for the Treatment of Knee Osteoarthritis
Cole BJ1,2,3,4,5, Karas V6, Hussey K1, Pilz K1,5, Fortier LA7.
Author information

Erratum in

• Corrigendum. [Am J Sports Med. 2017]

Abstract
BACKGROUND:
The use of platelet-rich plasma (PRP) for the treatment of osteoarthritis (OA) has demonstrated mixed clinical outcomes in randomized controlled trials when compared with hyaluronic acid (HA), an accepted nonsurgical treatment for symptomatic OA. Biological analysis of PRP has demonstrated an anti-inflammatory effect on the intra-articular environment.
PURPOSE:
To compare the clinical and biological effects of an intra-articular injection of PRP with those of an intra-articular injection of HA in patients with mild to moderate knee OA.
STUDY DESIGN:
Randomized controlled trial; Level of evidence, 1.
METHODS:
A total of 111 patients with symptomatic unilateral knee OA received a series of either leukocyte-poor PRP or HA injections under ultrasound guidance. Clinical data were collected before treatment and at 4 time points across a 1-year period. Synovial fluid was also collected for analysis of proinflammatory and anti-inflammatory markers before treatment and at 12 and 24 weeks after treatment. Several measures were used to assess results: (1) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale; (2) International Knee Documentation Committee (IKDC) subjective knee evaluation, visual analog scale (VAS) for pain, and Lysholm knee score; and (3) difference in intra-articular biochemical marker concentrations.
RESULTS:
There were 49 patients randomized to treatment with PRP and 50 randomized to treatment with HA. No difference was seen between the groups in the primary outcome measure (WOMAC pain score). In the secondary outcome measure, linear contrasts identified a significantly higher IKDC score in the PRP group compared with the HA group at 24 weeks (mean ± standard error [SE], 65.5 ± 3.6 vs 55.8 ± 3.8, respectively; P = .013) and at final follow-up (52 weeks) (57.6 ± 3.37 vs 46.6 ± 3.76, respectively; P = .003). Linear contrasts also identified a statistically lower VAS score in the PRP group versus the HA group at 24 weeks (mean ± SE, 34.6 ± 3.24 vs 48.6 ± 3.7, respectively; P = .0096) and 52 weeks (44 ± 4.6 vs 57.3 ± 3.8, respectively; P = .0039). An examination of fixed effects showed that patients with mild OA and a lower body mass index had a statistically significant improvement in outcomes. In the biochemical analysis, differences between groups approached significance for interleukin-1β (mean ± SE, 0.14 ± 0.05 pg/mL [PRP] vs 0.34 ± 0.16 pg/mL [HA]; P = .06) and tumor necrosis factor α (0.08 ± 0.01 pg/mL [PRP] vs 0.2 ± 0.18 pg/mL [HA]; P = .068) at 12-week follow-up.
CONCLUSION:
We found no difference between HA and PRP at any time point in the primary outcome measure: the patient-reported WOMAC pain score. Significant improvements were seen in other patient-reported outcome measures, with results favoring PRP over HA. Preceding a significant difference in subjective outcomes favoring PRP, there was a trend toward a decrease in 2 proinflammatory cytokines, which suggest that the anti-inflammatory properties of PRP may contribute to an improvement of symptoms. Registration: ClinicalTrials.gov (Identifier: NCT02588872).

I wish PRP was a "magic bullet" of a treatment that offered significant benefit. However, as in MANY instances in the history of pain management, the enthusiasm is directly related to reimbursement and is instituted on a widespread basis with little, if any evidence for efficacy. This approach has diminished the integrity of pain management in repeatedly implementing treatments before there is strong evidence to support its use.

Keep in mind, again, that many of us tried this in the mid 90s and it failed. Platelet rich plasma is still platelet rich plasma, and the facet joints and discs are still the facet joints and discs. Nobody bothered to publish these endeavors, as publishing negative data is somewhat frowned upon. Unfortunately, most of those advocating this treatment today did not live through the failures of the past and are eager to implement its use in their practice.

There is the natural fear of being "left behind" regarding new treatments for which there is great enthusiasm, vs engaging in and promoting a therapy of little efficacy, thus losing the confidence of patients in your judgement.

I do find it odd that there is such enthusiasm- perhaps the stuff might have a statistically positive effect with a p<.05, but if it was as great as everyone is saying, we would have seen at least 50% of the patients improve in the past (and we did not).

Think about this treatment for just a moment. Do you really, really believe that there is something in platelets that is going to result in a sustained and persistent effect when injected? It does not make any physiological sense whatsoever and defies common sense. Likewise, stem cells tagged with C14 when injected in the spine dissipate after only four hours. So how in the world is a "drug" (whatever drug is in the platelets) that is soluble in plasma expected to remain in place for a prolonged period of time and produce a long term effect?

 

[drusso]

So how in the world is a "drug" (whatever drug is in the platelets) that is soluble in plasma expected to remain in place for a prolonged period of time and produce a long term effect?

Stem Cells Dev. 2019 Jun 25. doi: 10.1089/scd.2019.0074. [Epub ahead of print]
The traceability of mesenchymal stromal cells after injection into degenerated discs in patients with low back pain.
Barreto Henriksson H1, Papadimitriou N2, Hingert D3, Baranto A4, Lindahl A5, Brisby H6.
Author information

Abstract
Low back pain is a major health issue and one main cause to this condition is believed to be intervertebral disc (IVD) degeneration. Stem cell therapy for degenerated discs using mesenchymal stromal cells (MSCs) has been suggested. The aim of the study was to investigate presence and distribution pattern of autologous MSCs transplanted into degenerated IVDs in patients and explanted post transplantation. IVD tissues from 4 patients (41,45, 47 and 47 years of age) participating in a clinical feasibility study on MSC transplantation to degenerative discs were investigated. Three patients decided to undergo fusion surgery at time-points 8 months and one patient at 28 months post transplantation. Pre-transplantation, MSCs from bone marrow aspirate, MSCs were isolated by centrifugation, FICOLL®-test-tubes and cultured (passage 1). Before transplantation, MSCs were labeled with 1 mg/mL iron-sucrose (Venofer®) and 1X106 MSCs were transplanted into degenerated IVDs. At the time-point of surgery, IVD tissues were collected. IVD tissue samples were fixated, embedded in paraffin and sections prepared. IVD samples were stained with Preussian blue which visualize iron deposits and examined (light microscopy). Immunohistochemistry (IHC) including SOX9, Coll2A1 and cell viability (TUNEL was performed. Cells positive for iron deposits were observed in IVD tissues (3/4 patients). The cells/iron deposits were observed in clusters and/or as solitary cells in regions in IVD tissue samples (ROIs). By IHC, SOX9 and Coll2A1 positive cells were detected in the same regions as detected cells/iron deposits. A few non-viable cells were detected by TUNEL assay in ROIs. Results demonstrated that MSCs, labelled with iron sucrose, transplanted into degenerated IVDs were detectable 8 months post transplantation. The detected cellular activity indicates that MSCs have differentiated into chondrocyte-like cells and that the injected MSCs and/or their progeny have survived since the cells were found in large cluster and as solitary cells which were distributed at different parts of the IVD.

 

[Ducttape]

ive wondered about this before....

how do my patients, who typically have demonstrated no healthy organ system, have chemicals in their blood that is going to help an injection site? wouldn't someone with underlying heart disease, hypertension, diabetes, hypercholesterolemia, renal dysfunction, COPD, damage from long term cigarette use, etc. not have platelets that are going to help with a specific joint? and should I be letting those platelets work in other vital organs, than a knee or elbow?

in a healthy athlete, it seems much more plausible...

 

[deleted993114]

Stem Cells Dev. 2019 Jun 25. doi: 10.1089/scd.2019.0074. [Epub ahead of print]
The traceability of mesenchymal stromal cells after injection into degenerated discs in patients with low back pain.
Barreto Henriksson H1, Papadimitriou N2, Hingert D3, Baranto A4, Lindahl A5, Brisby H6.
Author information

Abstract
Low back pain is a major health issue and one main cause to this condition is believed to be intervertebral disc (IVD) degeneration. Stem cell therapy for degenerated discs using mesenchymal stromal cells (MSCs) has been suggested. The aim of the study was to investigate presence and distribution pattern of autologous MSCs transplanted into degenerated IVDs in patients and explanted post transplantation. IVD tissues from 4 patients (41,45, 47 and 47 years of age) participating in a clinical feasibility study on MSC transplantation to degenerative discs were investigated. Three patients decided to undergo fusion surgery at time-points 8 months and one patient at 28 months post transplantation. Pre-transplantation, MSCs from bone marrow aspirate, MSCs were isolated by centrifugation, FICOLL®-test-tubes and cultured (passage 1). Before transplantation, MSCs were labeled with 1 mg/mL iron-sucrose (Venofer®) and 1X106 MSCs were transplanted into degenerated IVDs. At the time-point of surgery, IVD tissues were collected. IVD tissue samples were fixated, embedded in paraffin and sections prepared. IVD samples were stained with Preussian blue which visualize iron deposits and examined (light microscopy). Immunohistochemistry (IHC) including SOX9, Coll2A1 and cell viability (TUNEL was performed. Cells positive for iron deposits were observed in IVD tissues (3/4 patients). The cells/iron deposits were observed in clusters and/or as solitary cells in regions in IVD tissue samples (ROIs). By IHC, SOX9 and Coll2A1 positive cells were detected in the same regions as detected cells/iron deposits. A few non-viable cells were detected by TUNEL assay in ROIs. Results demonstrated that MSCs, labelled with iron sucrose, transplanted into degenerated IVDs were detectable 8 months post transplantation. The detected cellular activity indicates that MSCs have differentiated into chondrocyte-like cells and that the injected MSCs and/or their progeny have survived since the cells were found in large cluster and as solitary cells which were distributed at different parts of the IVD.

1. The discs are degenerative for a reason- the environment has become unfavorable for perpetuation of chondrocytes due to mechanical stress and poor diffusion of nutrients. If the native cells have died, why should we expect stem cells to thrive in such an environment?

2. Cells are not highly educated. Therefore any viable cells producing collagen fail to "weave" this material into a strong, lamellar configuration of the native disc. So IF cells survive and produce collagen, what good is it if it does nor form a lamellar configuration in the annulus?

3. The abstract says that cells were "observed" in clusters or as single cells. What good could a few viable cells possibly do?

4. There have been a few studies in which stem cells injected into "black discs" have resulted in rehydration of the discs on MRI. However, that did not correlate with improvement of back pain. What good are the treatments if they do not reduce pain?

 

[drusso]

ive wondered about this before....

how do my patients, who typically have demonstrated no healthy organ system, have chemicals in their blood that is going to help an injection site? wouldn't someone with underlying heart disease, hypertension, diabetes, hypercholesterolemia, renal dysfunction, COPD, damage from long term cigarette use, etc. not have platelets that are going to help with a specific joint? and should I be letting those platelets work in other vital organs, than a knee or elbow?

in a healthy athlete, it seems much more plausible...

"Host factors."

 

[drusso]

ive wondered about this before....

how do my patients, who typically have demonstrated no healthy organ system, have chemicals in their blood that is going to help an injection site? wouldn't someone with underlying heart disease, hypertension, diabetes, hypercholesterolemia, renal dysfunction, COPD, damage from long term cigarette use, etc. not have platelets that are going to help with a specific joint? and should I be letting those platelets work in other vital organs, than a knee or elbow?

in a healthy athlete, it seems much more plausible...

Another piece of the puzzle. PRP injections cause acute inflammation in tendons, but then patients fell better later...

Platelet-derived growth factor activates nociceptive... : PAIN

etitive firing of dissociated nociceptor-like rat dorsal root ganglion neurons and decreased their threshold for action potential generation. Injection of PDGF-BB into the paw produced nocifensive behavior in rats and led to thermal and mechanical pain hypersensitivity. We further detailed the...

journals.lww.com

 

[Ferrismonk]

ive wondered about this before....

how do my patients, who typically have demonstrated no healthy organ system, have chemicals in their blood that is going to help an injection site? wouldn't someone with underlying heart disease, hypertension, diabetes, hypercholesterolemia, renal dysfunction, COPD, damage from long term cigarette use, etc. not have platelets that are going to help with a specific joint? and should I be letting those platelets work in other vital organs, than a knee or elbow?

in a healthy athlete, it seems much more plausible...

The patient you mentioned is not likely to benefit much from regenerative medicine. Sorry. You need good protoplasm to have it work. It also seems to work better on mild to moderate problems, not severe.

 

[Ducttape]

okay, that rules out, er, 99% of my patients.......

 

[deleted993114]

The patient you mentioned is not likely to benefit much from regenerative medicine. Sorry. You need good protoplasm to have it work. It also seems to work better on mild to moderate problems, not severe.

So for things that will get better on their own?

It reminds me as well about our enthusiasm for vertebroplasty/kyphoplasty. We stopped doing it several years before the New England Journal and Spine articles, as it seemed the majority just got better if you left them alone and did nothing.

 

[drusso]

So for things that will get better on their own?

It reminds me as well about our enthusiasm for vertebroplasty/kyphoplasty. We stopped doing it several years before the New England Journal and Spine articles, as it seemed the majority just got better if you left them alone and did nothing.

This has been my experience too. Once NEJM and Up-to-Date came out on it negative, the referrals dried up. Still, there are people on this board that and you'll have to wrench their trochars and balloons from their cold, dead hands. @lobelsteve

 

[lobelsteve]

This has been my experience too. Once NEJM and Up-to-Date came out on it negative, the referrals dried up. Still, there are people on this board that and you'll have to wrench their trochars and balloons from their cold, dead hands. @lobelsteve

Funny, injecting unproven goo is ok. For big money. $tem$ell$

 

[drusso]

Funny, injecting unproven goo is ok. For big money. $tem$ell$

How much does your employer charge for a facility for vert aug at the hospital? That's big $$$.

Cartilage. 2018 Apr;9(2):161-170. doi: 10.1177/1947603517741169. Epub 2017 Nov 10.
Bone Marrow Aspirate Concentrate for Cartilage Defects of the Knee: From Bench to Bedside Evidence.
Cotter EJ1, Wang KC2, Yanke AB2, Chubinskaya S3.
Author information

Abstract
Objective To critically evaluate the current basic science, translational, and clinical data regarding bone marrow aspirate concentrate (BMAC) in the setting of focal cartilage defects of the knee and describe clinical indications and future research questions surrounding the clinical utility of BMAC for treatment of these lesions. Design A literature search was performed using the PubMed and Ovid MEDLINE databases for studies in English (1980-2017) using keywords, including ["bone marrow aspirate" and "cartilage"], ["mesenchymal stem cells" and "cartilage"], and ["bone marrow aspirate" and "mesenchymal stem cells" and "orthopedics"]. A total of 1832 articles were reviewed by 2 independent authors and additional literature found through scanning references of cited articles. Results BMAC has demonstrated promising results in the clinical application for repair of chondral defects as an adjuvant procedure or as an independent management technique. A subcomponent of BMAC, bone marrow derived-mesenchymal stem cells (MSCs) possess the ability to differentiate into cells important for osteogenesis and chondrogenesis. Modulation of paracrine signaling is perhaps the most important function of BM-MSCs in this setting. In an effort to increase the cellular yield, authors have shown the ability to expand BM-MSCs in culture while maintaining phenotype. Conclusions Translational studies have demonstrated good clinical efficacy of BMAC both concomitant with cartilage restoration procedures, at defined time points after surgery, and as isolated injections. Early clinical data suggests BMAC may help stimulate a more robust hyaline cartilage repair tissue response. Numerous questions remain regarding BMAC usage, including cell source, cell expansion, optimal pathology, and injection timing and quantity.
KEYWORDS:
articular cartilage; bone marrow aspirate; bone marrow aspirate concentrate; knee; mesenchymal stem cells

 

[lonelobo]

If a $5,000 PRP injection (never seen a such a thing) staves off a $10,000 arthroscopy for just 5 years; it's a winner every time just on the SOS arbitrage alone. Not even counting loss time from work, PT, potential procedural complications, etc.

do a little research $5000 injections are very prevalent, curious what do you charge?

 

[lonelobo]

It's being documented and quantified as we speak...

Procedural Comparison

regenexxcorporate.com

Please explain why PRP average cost for "Minor Procedure" for knee is $3000, but PRP for a knee that needs to be replaced is $8500?

 

[drusso]

Please explain why PRP average cost for "Minor Procedure" for knee is $3000, but PRP for a knee that needs to be replaced is $8500?

I have no idea. But, a patient just showed me an EOB for a OON ASC knee scope/meniscectomy for $44K. That's bank! And, I don't think it was even medically necessary. An $8K PRP injection in the office would be winner for the insurance company every time...that's what I tell the claims adjusters every time I have these conversations with them: $44K vs $XK. You do the math.

 

[lonelobo]

I have no idea. But, a patient just showed me an EOB for a OON ASC knee scope/meniscectomy for $44K. That's bank! And, I don't think it was even medically necessary. An $8K PRP injection in the office would be winner for the insurance company every time...that's what I tell the claims adjusters every time I have these conversations with them: $44K vs $XK. You do the math.

Why can't you explain?
This is directly off the Regenexx site you posted.
Nearly every " positive study" you post they are attached to

Didn't you just say there were no 5K inj but you mention an 8K inj? WTF?

In your example you are comparing two unproven techniques....so my math says that is a lose /lose proposition for the patient

 

[cowboydoc]

I have no idea. But, a patient just showed me an EOB for a OON ASC knee scope/meniscectomy for $44K. That's bank! And, I don't think it was even medically necessary. An $8K PRP injection in the office would be winner for the insurance company every time...that's what I tell the claims adjusters every time I have these conversations with them: $44K vs $XK. You do the math.

Extortion of $5k is less bad than $50k sounds like a terrible defense. Keep posting articles, and hopefully some more robust studies support your position. How does Regenexx address the selection bias of only patients coughing up $5k or more being included?

 

[drusso]

Why can't you explain?
This is directly off the Regenexx site you posted.
Nearly every " positive study" you post they are attached to

Didn't you just say there were no 5K inj but you mention an 8K inj? WTF?

In your example you are comparing two unproven techniques....so my math says that is a lose /lose proposition for the patient

I sit down with the contracts reps and say, "Why do you pay X, Y, or Z for procedure a, b, or c?" and they just look at me like sheep and bleet, "Bah, these are the rates the insurer has negotiated..."

What's been your experience getting transparency into how insurers set reimbursement?

 

[drusso]

Extortion of $5k is less bad than $50k sounds like a terrible defense. Keep posting articles, and hopefully some more robust studies support your position. How does Regenexx address the selection bias of only patients coughing up $5k or more being included?

It's all that the insurer agrees to pay...the problem with all of health care is that there is no transparency into how rates are set. I can't figure out why the hospital charges $3K for their OR why some insurance companies pay for the L-code for SCS and others don't.

 

[Ducttape]

for someone with arthritic changes, that $8000 for PRP is 15 PT appointments, 7 appointments to see you and 15 CBT appointments...

better yet, I guarantee you that if you pocketed $1000 and gave the patient $7000, he would feel a whole heck of a lot better....


FWIW, I googled QALY and PRP and stem cell, and I see..... nothing. maybe some will come out in the future, though...

 

[drusso]

for someone with arthritic changes, that $8000 for PRP is 15 PT appointments, 7 appointments to see you and 15 CBT appointments...

better yet, I guarantee you that if you pocketed $1000 and gave the patient $7000, he would feel a whole heck of a lot better....


FWIW, I googled QALY and PRP and stem cell, and I see..... nothing. maybe some will come out in the future, though...

What's your proposed mechanism of action for CBT on osteoarthritis? Also, in your experience, have you seen arthritic changes improve with PT?

 

[Ducttape]

no, but I haven't seen it get worse.

you know full well there is no "mechanism of action for CBT".

its called managing the negative psychological impact of chronic pain on quality of life.

 

[lonelobo]

I sit down with the contracts reps and say, "Why do you pay X, Y, or Z for procedure a, b, or c?" and they just look at me like sheep and bleet, "Bah, these are the rates the insurer has negotiated..."

What's been your experience getting transparency into how insurers set reimbursement?

NO one knows how insurances set reimbursement, But come on guy we are talking cash Pay. I don't know this for a fact , but I would guess 95% procedures are cash pay and not through insurance

 

[drusso]

no, but I haven't seen it get worse.

you know full well there is no "mechanism of action for CBT".

its called managing the negative psychological impact of chronic pain on quality of life.

Do you think CBT is just a placebo?

 

[Ferrismonk]

To clarify, I assume you mean stem cell treatments in the $3K to $8K range, correct? PRP is $500-$800 around here.

My PRP kit costs between $175 and $375 depending on what kind I use. Medicare pays $250 for in office LESI using $10 in supplies. Add in staff time, imaging, etc, and the cost isn't unreasonable at all.

 

[lonelobo]

Regenerative medicine is making the first inroads toward treating the causes of pain and all some people can do is talk it down and hope it fails just because it supplants what they were taught.

Nice website, sure the Natropaths love it

 

[lobelsteve]

How much does your employer charge for a facility for vert aug at the hospital? That's big $$$.

Cartilage. 2018 Apr;9(2):161-170. doi: 10.1177/1947603517741169. Epub 2017 Nov 10.
Bone Marrow Aspirate Concentrate for Cartilage Defects of the Knee: From Bench to Bedside Evidence.
Cotter EJ1, Wang KC2, Yanke AB2, Chubinskaya S3.
Author information

Abstract
Objective To critically evaluate the current basic science, translational, and clinical data regarding bone marrow aspirate concentrate (BMAC) in the setting of focal cartilage defects of the knee and describe clinical indications and future research questions surrounding the clinical utility of BMAC for treatment of these lesions. Design A literature search was performed using the PubMed and Ovid MEDLINE databases for studies in English (1980-2017) using keywords, including ["bone marrow aspirate" and "cartilage"], ["mesenchymal stem cells" and "cartilage"], and ["bone marrow aspirate" and "mesenchymal stem cells" and "orthopedics"]. A total of 1832 articles were reviewed by 2 independent authors and additional literature found through scanning references of cited articles. Results BMAC has demonstrated promising results in the clinical application for repair of chondral defects as an adjuvant procedure or as an independent management technique. A subcomponent of BMAC, bone marrow derived-mesenchymal stem cells (MSCs) possess the ability to differentiate into cells important for osteogenesis and chondrogenesis. Modulation of paracrine signaling is perhaps the most important function of BM-MSCs in this setting. In an effort to increase the cellular yield, authors have shown the ability to expand BM-MSCs in culture while maintaining phenotype. Conclusions Translational studies have demonstrated good clinical efficacy of BMAC both concomitant with cartilage restoration procedures, at defined time points after surgery, and as isolated injections. Early clinical data suggests BMAC may help stimulate a more robust hyaline cartilage repair tissue response. Numerous questions remain regarding BMAC usage, including cell source, cell expansion, optimal pathology, and injection timing and quantity.
KEYWORDS:
articular cartilage; bone marrow aspirate; bone marrow aspirate concentrate; knee; mesenchymal stem cells

I do them in the office because the hospital and ASC are impossibly slow. Interferes with my workouts.