Adding Regenerative medicine to your practice.

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lobelsteve said:
Malanga = PRP and MSC salesman. Down plays risks, upsells benefits. Badmouths alternative treatments including steroid injections with misleading or false statements.

SIS. 2019
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What kind of false and misleading statements? What kind of risks?


He’s IOF President. IOF today is what ISIS was circa 1994.
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drusso said:
What kind of false and misleading statements? He’s IOF President. IOF today is what ISIS was circa 1994.
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Single epidural can cause osteoporosis.
He was patently disingenuous in his representation of the studies he presented. Mostly level 4 or poorly designed level 3 to support his agenda.
 
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lobelsteve said:
Single epidural can cause osteoporosis.
He was patently disingenuous in his representation of the studies he presented. Mostly level 4 or poorly designed level 3 to support his agenda.
Click to expand...

Sit down and have a talk with Greg Lutz, I’m sure he’s there, another solid Mayo guy, he’ll open your eyes to some things in Regen spine care.
 
I guess he does it all for free.

And the research grants don’t help him either. And his stock/options/consulting agreements are each for $1.

Guess you only talk smart when it suits your arbitrage.
 
I agree stem cell therapy holds lots of promise. And should be the future of interventional care. But without reliable harvest, concentration, injection techniques and outcome studies validating primary endpoints in large RCTs, our cart is finished the race and our horse is still in the barn.
 
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lobelsteve said:
I guess he does it all for free.

And the research grants don’t help him either. And his stock/options/consulting agreements are each for $1.

Guess you only talk smart when it suits your arbitrage.
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I’m not saying he doesn’t hype his research and outcomes. I’m just saying in my experience there are less COI hazards doing Regen stuff than most other things in pain management. I don’t know many Regen docs buying Bentley’s with money from their cash-based office practice with no SOS, Pharma money, stim churning, toxicology kick backs, etc. Some might have patents and inventions, but that not a COI per se...
 
lobelsteve said:
I agree stem cell therapy holds lots of promise. And should be the future of interventional care. But without reliable harvest, concentration, injection techniques and outcome studies validating primary endpoints in large RCTs, our cart is finished the race and our horse is still in the barn.
Click to expand...

Don’t you think that’s what’s happening? I’m collecting data. So are many others. Besides a little venture capital there are no deep pockets in this space. Today, the field of orthobiologics is like a bunch guys meeting in the back of Radio Shack in 1970’s and trying to build personal computers and showing off their Ham radios sets. But, from that innovation we can imagine the next Silicon Valley as long as big government liberals and Big Pharma stay out of the way.
 
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drusso said:
Don’t you think that’s what’s happening? I’m collecting data. So are many others. Besides a little venture capital there are no deep pockets in this space. Today, the field of orthobiologics is like a bunch guys meeting in the back of Radio Shack in 1970’s and trying to build personal computers and showing off their Ham radios sets. But, from that innovation we can imagine the next Silicon Valley as long as big government liberals and Big Pharma stay out of the way.
Click to expand...

Collecting data individually using your multiple methods adds very little to the science. Couple that with the 95+% of $tem$ells injected are not stem cells and done by assclowns really limits the field.
 
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drusso said:
I’m not saying he doesn’t hype his research and outcomes. I’m just saying in my experience there are less COI hazards doing Regen stuff than most other things in pain management. I don’t know many Regen docs buying Bentley’s with money from their cash-based office practice with no SOS, Pharma money, stim churning, toxicology kick backs, etc. Some might have patents and inventions, but that not a COI per se...
Click to expand...
drusso said:
You


Sit down and have a talk with Greg Lutz, I’m sure he’s there, another solid Mayo guy, he’ll open your eyes to some things in Regen spine care.
Click to expand...


I am just curious as to why the same PRP injected at the same sites in the spine did not work in the mid 90s, but is very successful today? I can tell you I did quite a bit of it and it didn't work. How in the world could we have something that is so effective yield essentially placebo responses by dozens of providers 25 years ago? Are we accepting placebo level "successes" as being sufficient to support the implementation of a technique?

I am VERY skeptical of the "successes" of PRP today, as the papers touting its efficacy are poor. This reminds me very much of IDET and all the Ken Allo techniques that are very effective in the hands of a few providers who are making a lot of money off them, and do not work at all when implemented on a more widespread basis. In attending the ASIP meetings (been to two specifically to hear about this), the "evidence" were some very poor studies and anecdotal patient video testimonials, which were greeted with wild enthusiasm and cheers from an audience that was more akin to an AMWAY meeting than a medical meeting.

It makes no sense whatsoever from a physiological standpoint. If PRP was so great, then trauma and bleeding into anatomic structures should be therapeutic.

1. Why don't people who sustain severe flexion/extension injuries in the lumbar and cervical spine, sustaining injury and some hematomas within the facet joints, not produce analgesia, instead of pain?

2. Why don't people get relief of back pain after a lumbar discectomy? There is some bleeding that occurs and one would assume this blood would produce tremendous analgesia. Yet people still have back pain after a discectomy.

3. Why don't epidural blood patches cure back pain?

4. Why are the studies supporting PRP in the spine so poor?

5. MOST ligamentous injuries involve some bleeding into the ligaments/tendons. Why are they not all better as a result of this, instead of reporting pain?

It makes no physiologic sense at all, yet has captured the imagination of many providers today. I fear this is another procedure/concept that has been wheeled out for widespread use with very, very little data to support its use in the spine. Pain management has suffered from such approaches many times in the past and it does nothing to gain medical credibility when one farce after another is widely promoted.
 
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drusso said:
Don’t you think that’s what’s happening? I’m collecting data. So are many others. Besides a little venture capital there are no deep pockets in this space. Today, the field of orthobiologics is like a bunch guys meeting in the back of Radio Shack in 1970’s and trying to build personal computers and showing off their Ham radios sets. But, from that innovation we can imagine the next Silicon Valley as long as big government liberals and Big Pharma stay out of the way.
Click to expand...

If you are going to collect personal data, it really needs to be collected independently by an employee who is blinded to the specific material injected. It is not as good as an actual controlled study, but lends some objectivity to clinical outcomes. We always used to have such people hired when collecting individual data, and it was somewhat surprising and sobering to see what an unbiased observer collects and observes vs our individual perceptions.

This is the reason that open label studies (most of the PRP studies are such) should always be viewed with a high degree of suspicion, as you have both the provider and the patient expecting and encouraging an outcome which may not be real. Such "science" is poor, at best, and just jams the literature up with studies that are perceived to be valid by people who don't know any better. There are people on this very site that have vehemently defended an open label PRP study as strong evidence for its efficacy.......................... now that just aint right.
 
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hawkeye2009 said:
If you are going to collect personal data, it really needs to be collected independently by an employee who is blinded to the specific material injected. It is not as good as an actual controlled study, but lends some objectivity to clinical outcomes. We always used to have such people hired when collecting individual data, and it was somewhat surprising and sobering to see what an unbiased observer collects and observes vs our individual perceptions.

This is the reason that open label studies (most of the PRP studies are such) should always be viewed with a high degree of suspicion, as you have both the provider and the patient expecting and encouraging an outcome which may not be real. Such "science" is poor, at best, and just jams the literature up with studies that are perceived to be valid by people who don't know any better. There are people on this very site that have vehemently defended an open label PRP study as strong evidence for its efficacy.......................... now that just aint right.
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It's collected by an independent third-party registry and outcomes are tracked longitudinally over years. There are limitations, but no one I know is collecting longitudinal data on kypho outcomes, pulsed RF, SIJ denervation, genicular RF, etc.
 
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drusso said:
It's collected by an independent third-party registry and outcomes are tracked longitudinally over years. There are limitations, but no one I know is collecting longitudinal data on kypho outcomes, pulsed RF, SIJ denervation, genicular RF, etc.
Click to expand...

Okay- that's cool. It's best to do it that way.

I can tell you that in the mid 90s, cervical rf and dorsal column stim worked, and it still works today. I am wondering how and why PRP in the spine did not work at all then, and now it works so well? Plasma hasn't changed, nor has the ability to access these structures under fluoro.

It just does not make sense. If PRP is so great for pain, why does anyone need any pain meds after any surgery? There is plenty of exposure of tissue to plenty of platelets, yet they hurt more after surgery, not less. Why is it that compound fractures hurt, instead of feeling good? There is plenty of PRP and even bone marrow being exposed to injured tissue. Compound fractures should feel just dandy, yet they hurt like hell. One of my former neurosurg partners had a compound fracture of the femur two years ago while skiing in Switzerland- it hurt him like hell.

I am all for anything that helps and works, but I really, really would prefer that pain management did not roll out procedures to be used in a widespread basis around the US with little or no evidence to support it. I would think that if the patients truly were informed about the paucity of evidence, they would not consent to such treatments.

Maybe its different this time, but I just have a hard time believing it. You should call Steve Levine in Indianapolis; he was "this year's model" in the mid 90s (just prior to Way Yin) and really embraced PRP, but abandoned it, due to lack of efficacy. He really bought whole hog into the treatment. I have noticed that he has been conspicuously silent in this latest PRP craze.

Maybe there is something to this in peripheral ligaments and tendons. I know that Mayo has had some preliminary positive (albeit limited) success in that application. However, regarding the spine- been there, done that- and it just didn't work.
 
drusso said:
It's collected by an independent third-party registry and outcomes are tracked longitudinally over years. There are limitations, but no one I know is collecting longitudinal data on kypho outcomes, pulsed RF, SIJ denervation, genicular RF, etc.
Click to expand...
what is the bias by the 3rd party registry if it is paid by the PRP company?
 
Ducttape said:
then there is potential for COI...
Click to expand...

Here's some data for PRP in the knee OA I just pulled for the last two years...do you have data for what you do?

1565958333920.png
 
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no.

but I do have this, from last patient of the day:

"Patent presents for evaluation regarding pain in the lower back, history of sacroiliac dysfunction on the right.
Patient last seen in 2013, after undergoing right sacroiliac injection. had almost complete relief of symptoms until this past January - had been doing a lot more driving for "sick" boyfriend. he owns a Ford Escape and she thinks getting in and out of the higher vehicle contributed to return of pain.
it is stabbing pain and after work it is aching discomfort. pain exactly like previoius pain."
 
drusso said:
Here's some data for PRP in the knee OA I just pulled for the last two years...do you have data for what you do?

View attachment 276461
Click to expand...
Correct me if I’m wrong but does that show a basically 1.5 point difference in pain from PRP? Is this missing the pre-treatment pain score? If not, why are people with an average pain score of 3 getting so many injections?
 
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callmeanesthesia said:
Correct me if I’m wrong but does that show a basically 1.5 point difference in pain from PRP? Is this missing the pre-treatment pain score? If not, why are people with an average pain score of 3 getting so many injections?
Click to expand...

They got 1 injection. Basically pain from 4 to 2.
 
drusso said:
It's collected by an independent third-party registry and outcomes are tracked longitudinally over years. There are limitations, but no one I know is collecting longitudinal data on kypho outcomes, pulsed RF, SIJ denervation, genicular RF, etc.
Click to expand...
And correct me if I'm wrong here, but Regenexx also collects and collates across all Regenexx affiliated clinics, thus reducing problems with collecting from one single doctor or clinic.


hawkeye2009 said:
Okay- that's cool. It's best to do it that way.

I can tell you that in the mid 90s, cervical rf and dorsal column stim worked, and it still works today. I am wondering how and why PRP in the spine did not work at all then, and now it works so well? Plasma hasn't changed, nor has the ability to access these structures under fluoro.

It just does not make sense. If PRP is so great for pain, why does anyone need any pain meds after any surgery? There is plenty of exposure of tissue to plenty of platelets, yet they hurt more after surgery, not less. Why is it that compound fractures hurt, instead of feeling good? There is plenty of PRP and even bone marrow being exposed to injured tissue. Compound fractures should feel just dandy, yet they hurt like hell. One of my former neurosurg partners had a compound fracture of the femur two years ago while skiing in Switzerland- it hurt him like hell.

I am all for anything that helps and works, but I really, really would prefer that pain management did not roll out procedures to be used in a widespread basis around the US with little or no evidence to support it. I would think that if the patients truly were informed about the paucity of evidence, they would not consent to such treatments.

Maybe its different this time, but I just have a hard time believing it. You should call Steve Levine in Indianapolis; he was "this year's model" in the mid 90s (just prior to Way Yin) and really embraced PRP, but abandoned it, due to lack of efficacy. He really bought whole hog into the treatment. I have noticed that he has been conspicuously silent in this latest PRP craze.

Maybe there is something to this in peripheral ligaments and tendons. I know that Mayo has had some preliminary positive (albeit limited) success in that application. However, regarding the spine- been there, done that- and it just didn't work.
Click to expand...
To be fair, PRP and Stem Cell treatments often DO hurt. The argument is that the injury/defect heals faster/better and thus pain is eventually diminished. It's not just a shot of local and steroid to make you feel better.

Orthopods have been doing microfracture for a long time. a.k.a adding (unconcentrated) bone marrow stem cells to repair cartilage defects. There are real-world regenerative applications that have been used with success for years.
 
drusso said:
They got 1 injection. Basically pain from 4 to 2.
Click to expand...

That does not seem like a huge improvement to me at all.

I guess when people are determining whether something is successful or not, it depends on the perception. I really want to see a pretty significant improvement to consider something effective, not just a p, .05, or a reduction from a "4" to a "2". I think it is great that you are keeping data on this, which is beyond what most everyone else is doing.

To each his own, however. Ultimately, the main thing is whether the patient considers the benefit to be worth the cost.
 
Ferrismonk said:
And correct me if I'm wrong here, but Regenexx also collects and collates across all Regenexx affiliated clinics, thus reducing problems with collecting from one single doctor or clinic.



To be fair, PRP and Stem Cell treatments often DO hurt. The argument is that the injury/defect heals faster/better and thus pain is eventually diminished. It's not just a shot of local and steroid to make you feel better.

Orthopods have been doing microfracture for a long time. a.k.a adding (unconcentrated) bone marrow stem cells to repair cartilage defects. There are real-world regenerative applications that have been used with success for years.
Click to expand...

The ortho literature really shows a lot of failures and continuation of ineffective treatments.
 
lobelsteve said:
Collecting data individually using your multiple methods adds very little to the science. Couple that with the 95+% of $tem$ells injected are not stem cells and done by assclowns really limits the field.
Click to expand...


"As in any area of medicine, treatments that are improperly performed without attention to standards and guidelines will result in the potential for serious complications. It is therefore critical that any treatment, in particular new and innovative treatment, is performed with appropriate training, standards and guidelines. IOF is advocating for the creation of a standardized national registry database to ensure clinicians using the highest level of techniques are able to collect the outcomes of these treatments and establish their efficacy. A national registry will empower clinicians using research-based techniques while dissuading those who wish to take advantage of vulnerable patient populations by using non-standardized techniques and slick marketing to sell procedures that are ineffective at best and deadly at worst.

Ultimately, treatments that are in the best interest of the patient will be offered and provided using the best available techniques."
 
drusso said:

"As in any area of medicine, treatments that are improperly performed without attention to standards and guidelines will result in the potential for serious complications. It is therefore critical that any treatment, in particular new and innovative treatment, is performed with appropriate training, standards and guidelines. IOF is advocating for the creation of a standardized national registry database to ensure clinicians using the highest level of techniques are able to collect the outcomes of these treatments and establish their efficacy. A national registry will empower clinicians using research-based techniques while dissuading those who wish to take advantage of vulnerable patient populations by using non-standardized techniques and slick marketing to sell procedures that are ineffective at best and deadly at worst.

Ultimately, treatments that are in the best interest of the patient will be offered and provided using the best available techniques."
Click to expand...

Oh good. Do you have 100% of all people getting stem cell therapy using this? How about 1%?
 
hawkeye2009 said:
That does not seem like a huge improvement to me at all.

I guess when people are determining whether something is successful or not, it depends on the perception. I really want to see a pretty significant improvement to consider something effective, not just a p, .05, or a reduction from a "4" to a "2". I think it is great that you are keeping data on this, which is beyond what most everyone else is doing.

To each his own, however. Ultimately, the main thing is whether the patient considers the benefit to be worth the cost.
Click to expand...
4 to 2 can be interpreted as 50% improvement.
and to be able to get FDA approval for a specific condition a 2 point drop is considered sufficient... see Cymbalta and Lyrica.

just saying...
 
Ducttape said:
4 to 2 can be interpreted as 50% improvement.
and to be able to get FDA approval for a specific condition a 2 point drop is considered sufficient... see Cymbalta and Lyrica.

just saying...
Click to expand...

How do FDA approve a own person's tissue? NO government should be allowed to regulate a human's body tissues for autologous use.
 

New Academic Delphi Panel Formed to Define Best Practices for Using Bone Marrow Concentrate

/PRNewswire/ -- A multidisciplinary/interdisciplinary group of orthobiologics experts from the fields of orthopedic surgery, sports medicine, physical medicine...
www.prnewswire.com www.prnewswire.com

"A multidisciplinary/interdisciplinary group of orthobiologics experts from the fields of orthopedic surgery, sports medicine, physical medicine and rehabilitation, pain medicine, and interventional spine have embarked on a Delphi panel process to set treatment standards for patients receiving a same day stem cell procedure known as bone marrow concentrate. Orthopedic stem cell treatment and orthobiologics is increasingly coming under fire from academic bench scientists who believe there is not enough research nor practice standards. While recent attempts like the DOSES Delphi panel have attempted to describe benchmarks for the cellular composition of orthobiologics, there are no practice guidelines and as a result, the field has been described as "The Wild West."
 
okay...

then what good are these guidelines if they are from people who already believe that these treatments are 100% effective?
 
Ducttape said:
okay...

then what good are these guidelines if they are from people who already believe that these treatments are 100% effective?
Click to expand...

They smash the bad apples. I read a depo on a chiro employed quack FNP who attempted non-image guided thoracic Amniofix TPI's on a patient with "Scheurman's Disease" and dropped a lung. These people are going to be shut down...
 
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Does anybody have a link to published evidence that PRP/BMAC strengthens ligaments/muscles? A lot of protocols I've been seeing discuss using it to help stabilize structures (interspinous ligaments, multifidus, etc). There is research coming out every day, but I'm having trouble finding this info. Can you guys point out some studies?
 
Ferrismonk said:
Does anybody have a link to published evidence that PRP/BMAC strengthens ligaments/muscles? A lot of protocols I've been seeing discuss using it to help stabilize structures (interspinous ligaments, multifidus, etc). There is research coming out every day, but I'm having trouble finding this info. Can you guys point out some studies?
Click to expand...

There's this for muscles:

World J Orthop. 2019 Jul 18;10(7):278-291. doi: 10.5312/wjo.v10.i7.278. eCollection 2019 Jul 18.
Platelet-rich plasma for muscle injuries: A systematic review of the basic science literature.
Kunze KN1, Hannon CP2, Fialkoff JD2, Frank RM3, Cole BJ4.
Author information

Abstract
BACKGROUND:
Platelet-rich plasma (PRP) is an increasingly used biologic adjunct for muscle injuries, as it is thought to expedite healing. Despite its widespread use, little is known regarding the mechanisms by which PRP produces its efficacious effects in some patients.
AIM:
To clarify the effects of PRP on muscular pathologies at the cellular and tissue levels by evaluating the basic science literature.
METHODS:
A systematic review of PubMed/MEDLINE and EMBASE databases was performed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and checklist. Level III in vivo and in vitro studies examining PRP effects on muscles, myocytes and/or myoblasts were eligible for inclusion. Extracted data included PRP preparation methods and study results.
RESULTS:
Twenty-three studies were included (15 in vivo, 6 in vitro, 2 in vitro/in vivo). Only one reported a complete PRP cytology (platelets, and red and white blood cell counts). Five in vitro studies reported increased cellular proliferation, four reported increased gene expression, and three reported increased cellular differentiation. Five in vivo studies reported increased gene expression, three reported superior muscle regeneration, and seven reported improved histological quality of muscular tissue.
CONCLUSION:
The basic science literature on the use of PRP in muscle pathology demonstrates that PRP treatment confers several potentially beneficial effects on healing in comparison to controls. Future research is needed to determine optimal cytology, dosing, timing, and delivery methods of PRP for muscle pathologies.
KEYWORDS:
Basic science; Injury; Muscle; Musculoskeletal; Platelet rich plasma
 

Science | AAAS

advances.sciencemag.org advances.sciencemag.org

here is the true future of Regenerative Medicine, not harvesting PRP, but injecting microRNA...


Moreover, injection of key regenerative miRNA in a joint, singly or in combination, could potentially enhance endogenous repair and resist degeneration of joint tissues in arthritis of all types including after traumatic injury or insult. Findings such as these, related to innate repair, could also be applied to tissue-engineered constructs to enhance exogenous tissue generation prior to transplantation. Identification of key “missing” (expressed in limb-regenerating organisms but not in mammals) factors, including miRNA, could lead to future use of a “molecular cocktail” for attempted recapitulation of blastema-mediated limb regeneration in humans.
Click to expand...
 
Ducttape said:

Science | AAAS

advances.sciencemag.org advances.sciencemag.org

here is the true future of Regenerative Medicine, not harvesting PRP, but injecting microRNA...
Click to expand...

Not ready for prime time and definitely not Kosher under current FDA guidelines. I would discourage practitioners from pursuing these treatments.

regenexx.com

What Is Exosome Therapy? - Regenexx Blog

One of the hottest areas of regenerative medicine right now is exosome therapy. Have you ever wondered what is exosome therapy?
regenexx.com regenexx.com
 
oh yes I agree not ready now,

but in terms of science, here you have something that appears to have better physiologic basis for actual regeneration. I'm not thinking the future will be cells ie this exosome therapy, but the actual microRNA.
 
My proposed mechanism for how PRP works:

Puts you in a pain flare for a couple weeks so your baseline pain doesn't seem quite as bad.

And that's about it.
 
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Centeno seems to occasionally be at war with exosomes, currently on social media. He’s calling the FDA on the few labs making exosomes.
 
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