Adding Regenerative medicine to your practice.

[Doctodd]

I dont agree that saline injection is a placebo. And it seems like corticosteroids should never be used again in some joints...

"A recent randomized clinical trial conducted by McAlidon, et al. compared corticosteroid (triamcinolone) use to saline in patients with KOA. The authors found that the use of IA triamcinolone resulted in greater cartilage volume loss compared with saline based on MRI, along with no significant difference in knee pain severity between the two groups"

Clinical Update: Why PRP Should Be Your First Choice for Injection Therapy in Treating Osteoarthritis of the Knee

The purpose of this review is to update the reader on the current applications of platelet-rich plasma (PRP) in the treatment of knee osteoarthritis (KOA). This review will focus on PRP’s effect on the osteoarthritic joint, how PRP compares to ...

www.ncbi.nlm.nih.gov

---

Members don't see this ad.

 

[drusso]

Drusso -

You are probably right that the biochemical makeup of placenta based tissue, and PRP are different. But maybe the placenta based product is better...or maybe mix them.

Regarding the company - it is a phenomenal and CRAZY story. I hope someone does a documentary on it. It is unbelievable that a single person on TWITTER could cause such a SH&T storm, get people to believe it (including writers at the New York Times) and get the company involved in expensive legal issues - all so this guy on Twitter can make a gazillion dollars by shorting the stock. It is really funny actually.

Having said that - who cares what legal troubles the company is in. Using their product is not like "getting into business" with them. The reps are honest. The product works amazingly well - and has 5 level I evidence studies to back it up with more to come. Why would you care if two reps did some channel stuffing? How does that change anything regarding clinical decision making?

The Birth-Tissue Profiteers

How well-meaning donations end up fueling an unproven, virtually unregulated $2 billion stem cell industry.

www.propublica.org

Choose who you do business wisely...

 

[epidural man]

The Birth-Tissue Profiteers

How well-meaning donations end up fueling an unproven, virtually unregulated $2 billion stem cell industry.

www.propublica.org

Choose who you do business wisely...

Absolutely! Luckily the products I use have good data behind them, and don't claim to have any live tissue. Many of the amniotic/placental based companies make live tissue claims which just aren't true.

 

[Ducttape]

joint and inflammatory process remains distinctly different from spine.

your highlighted point is what I am getting at. I see no real studies posted that show that it is superior to "standard of care" over long term. studies that compare PRP in differing doses against saline are not comparing PRP to standard of care and not long enough.

saline injections are not standard of care for osteoarthritis. 3 month benefit is great. but for me to buy in, id need to see improvement in functioning >3 months. and Medicare approval, as 75%+ of patients I see have Care/Caid...

 

[drusso]

joint and inflammatory process remains distinctly different from spine.

your highlighted point is what I am getting at. I see no real studies posted that show that it is superior to "standard of care" over long term. studies that compare PRP in differing doses against saline are not comparing PRP to standard of care and not long enough.

saline injections are not standard of care for osteoarthritis. 3 month benefit is great. but for me to buy in, id need to see improvement in functioning >3 months. and Medicare approval, as 75%+ of patients I see have Care/Caid...

Tell me how inflammation in a DIP joint is different from a facet joint and why the treatment of one would be different from the treatment of another.

I said non-inferior, not superior. Dunking patients in corticosteroid is not acceptable. If your panel is 75% Care/Caid you're likely harming patients by exposing them to decades of steroids. But, I'm certain it feeds your kypho/vert practice and generates good Physician Enterprise Value by feeding your ortho surgeons THA's, TKA's, etc.

That's the game right? It's how pain doctors all over the country are winning the RVU arbitrage/SOS diff game and paying for their souped-up Jeeps, 4x4's, backyard pool remodels, and racing cars.

 

[lonelobo]

Tell me how inflammation in a DIP joint is different from a facet joint and why the treatment of one would be different from the treatment of another.

I said non-inferior, not superior. Dunking patients in corticosteroid is not acceptable. If your panel is 75% Care/Caid you're likely harming patients by exposing them to decades of steroids. But, I'm certain it feeds your kypho/vert practice and generates good Physician Enterprise Value by feeding your ortho surgeons THA's, TKA's, etc.

That's the game right? It's how pain doctors all over the country are winning the RVU arbitrage/SOS diff game and paying for their souped-up Jeeps, 4x4's, backyard pool remodels, and racing cars.

Seems to me someone on these blogs purports the Stem Cell and PRP use loves to show pictures of his boat

 

[drusso]

Seems to me someone on these blogs purports the Stem Cell and PRP use loves to show pictures of his boat

Once @Ducttape tried to argue that inflammation is different in different parts of the body, I decided I was done with rational arguments and wanted to blow up this place!

 

[sloh]

SAGE Journals: Your gateway to world-class research journals

Subscription and open access journals from SAGE Publishing, the world's leading independent academic publisher.

journals.sagepub.com

Published April 30, 2019

"Combined with an exercise-based rehabilitation program, a single injection of LR-PRP or LP-PRP was no more effective than saline for the improvement of patellar tendinopathy symptoms."

Follow-up at 1 year

 

[Ducttape]

Tell me how inflammation in a DIP joint is different from a facet joint and why the treatment of one would be different from the treatment of another.

I said non-inferior, not superior. Dunking patients in corticosteroid is not acceptable. If your panel is 75% Care/Caid you're likely harming patients by exposing them to decades of steroids. But, I'm certain it feeds your kypho/vert practice and generates good Physician Enterprise Value by feeding your ortho surgeons THA's, TKA's, etc.

That's the game right? It's how pain doctors all over the country are winning the RVU arbitrage/SOS diff game and paying for their souped-up Jeeps, 4x4's, backyard pool remodels, and racing cars.

I agree that dunking ppl in steroids for joint processes is not the best care and my practice pattern reflects that.

I stand with the position that there is some evidence for regenerative medicine to be "beneficial short term" in joints but a paucity in spine. (interestingly, when I mention that there is paucity for evidence for benefit in spine, ppl invariably ignore the "in spine" part, and post invariably the same 4-5 joint or tendon studies. it is a fallacy to simply extend data from joint to spine: proof is required)

for spine care, steroids are still used, id rather not dunk them in any treatments that don't carry superior evidence. first, most would never access such care. second, if one has to dunk them in some care that doesn't have good level evidence, best make it in treatment that is not harmful. the vast majority of what I do is to encourage active exercise, cognitive therapies, and more holistic approaches.

I'm not winning the RVU battle. I'm in debt, drive 10 year old cars, and wear the same New Balance shoes for the past 3 years. my office visits and procedures are not under SOS differential (injections at ASC, which anyone can do), although the system could do so easily if it changed its mind.

 

[lobelsteve]

Once @Ducttape tried to argue that inflammation is different in different parts of the body, I decided I was done with rational arguments and wanted to blow up this place!

Is there any inflammation in either long term? How do you measure that for your proposed study? Esr/crp? Bone scan? I dont think chronic pain in those joints we treat of the spine would show either.

 

[lonelobo]

The Birth-Tissue Profiteers — ProPublica

 

[drusso]

Is there any inflammation in either long term? How do you measure that for your proposed study? Esr/crp? Bone scan? I dont think chronic pain in those joints we treat of the spine would show either.

This is an active area of research too. My group is contributing pre/post synovial fluid samples for multiplex ELISA testing trying to understand how orthobiologic impact joint chemistry...can't plant good seeds in bad soil and expect results.

Exp Gerontol. 2017 Jul;93:68-72. doi: 10.1016/j.exger.2017.04.004. Epub 2017 Apr 20.
The influence of platelet rich plasma on synovial fluid volumes, protein concentrations, and severity of pain in patients with knee osteoarthritis.
Chen CPC1, Cheng CH2, Hsu CC3, Lin HC1, Tsai YR1, Chen JL4.
Author information

Abstract
Knee pain is commonly seen in orthopedic and rehabilitation outpatient clinical settings. Patients with knee osteoarthritis (OA) are often complicated with joint soreness, swelling, weakness, and pain. These complaints are often caused by the excessive amount of synovial fluid (SF) accumulated in the bursae around the knee joint. This study was aimed to evaluate the effectiveness of platelet rich plasma (PRP) in treating patients with minor to moderate knee osteoarthritis (OA) combined with supra-patellar bursitis using a proteomic approach and clinical evaluation tool. In this study, 24 elderly patients with minor to moderate knee OA combined with supra-patellar bursitis were recruited. Musculoskeletal ultrasound was used for accurate needle placement for the aspiration of SF followed by subsequent PRP injections. Three monthly PRP injections were performed to the affected knees for a total of 3months. Approximately after the 2nd PRP injection, significant decreases in SF total protein concentrations, volumes, and Lequesne index values were observed. SF proteins associated with chelation and anti-aging physiological functions such as matrilin, transthyretin, and complement 5 increased at least 2-fold in concentrations. Proteins associated with inflammation, such as apolipoprotein A-I, haptoglobin, immunoglobulin kappa chain, transferrin, and matrix metalloproteinase decreased at least 2-fold in concentrations. Therefore, at least two monthly PRP injections may be beneficial for treating patients with minor to moderate knee OA combined with supra-patellar bursitis.

 

[Nonphysiologic]

Are you guys using ultrasound or just doing PrP blind?

 

[Dr. Ice]

Are you guys using ultrasound or just doing PrP blind?

Is this a real question? Smh

 

[lonelobo]

Are you guys using ultrasound or just doing PrP blind?

When you are doing unproven treatments, does it really matter?

 

[drusso]

When you are doing unproven treatments, does it really matter?

Yes. It even matters if you're injecting inert latex. I would swear on a stack of Bibles at a deposition that not using image guidance for regenerative therapy injections was below the standard of care.


PM R. 2017 Oct;9(10):998-1005. doi: 10.1016/j.pmrj.2016.12.012. Epub 2017 Jan 16.
Sonographically Guided Knee Meniscus Injections: Feasibility, Techniques, and Validation.
Baria MR1, Sellon JL2, Lueders D3, Smith J4.
Author information

Abstract
BACKGROUND:
There is a growing interest in the use of biologic agents such as platelet-rich plasma and mesenchymal stem/stromal cells to treat musculoskeletal injuries, including meniscal tears. Although previous research has documented the role of diagnostic ultrasound to evaluate meniscal tears, sonographically guided (SG) techniques to specifically deliver therapeutic agents into the meniscus have not been described.
OBJECTIVE:
To describe and validate SG injection techniques for the body and posterior horn of the medial and lateral meniscus.
DESIGN:
Prospective, cadaveric laboratory investigation.
SETTING:
Academic institution procedural skills laboratory.
SUBJECTS:
Five unenbalmed cadaveric knee-ankle-foot specimens from 5 donors (3 female and 2 male) ages 33-92 years (mean age 74 years) with body mass indices of 21.1-32.4 kg/m2 (mean 24.1 kg/m2).
METHODS:
A single, experienced operator completed SG injections into the bodies and posterior horns of the medial and lateral menisci of 5 unenbalmed cadaveric knees using colored latex and a 22-gauge, 38-mm needle. After injection, coinvestigators dissected each specimen to assess latex distribution within the menisci and identify injury to intra-articular and periarticular structures.
MAIN OUTCOME MEASURES:
Latex location within the target region of meniscus (accurate/inaccurate), and iatrogenic injury to "at risk" intra- and periarticular structures (present/absent).
RESULTS:
Seventeen of 20 injections were accurate. Two of 3 inaccurate injections infiltrated the posterior horn of the medial meniscus instead of the targeted meniscal body. One inaccurate lateral meniscus injection did not contain latex despite sonographically accurate needle placement. No specimen exhibited injury to regional neurovascular structures or intra-articular hyaline cartilage.
CONCLUSIONS:
SG meniscus injections are feasible and can accurately and safely deliver injectates such as regenerative agents into bodies and posterior horns of the medial and lateral menisci. The role of SG intrameniscal injections in the treatment of patients with degenerative and traumatic meniscal disorders warrants further exploration.
LEVEL OF EVIDENCE:
Not applicable.

 

[lonelobo]

Obviously I believe in imaging for injections, unproven cash pay treatments not so much

 

[drusso]

Obviously I believe in imaging for injections, unproven cash pay treatments not so much

How does payment or proof impact the accuracy of placement of any injectate (not just orthobiologics)?

People paying post-tax, hard-earned cash for unproven treatments deserve equal injection accuracy as people using insurance benefits for proven treatments.

 

[lonelobo]

How does payment or proof impact the accuracy of placement of any injectate (not just orthobiologics)?

People paying post-tax, hard-earned cash for unproven treatments deserve equal injection accuracy as people using insurance benefits for proven treatments.

I believe these people don't deserve a Chiropractic like sales pitch of a unproven product to line the pockets of the provider

 

[cowboydoc]

I'm doing a Regenexx course this upcoming weekend. I hope I leave with some new tools but I'm skeptical.

Feedback???

 

[lonelobo]

Feedback???

What is there to be skeptical of?

Herniated Disc - Regenexx

www.regenexx.com

 

[SommeRiver]

Feedback???

I should say it was not put on by Regenexx, but did take place in one of their buildings.

A good one day course.

It was for intradiscal and extradiscal biologics, and focused on technical skills via cadavers. We did fluoro and US techniques, but we didn't get into data or literature - It was all hands on stuff.

They offer a lot of courses and this was the advanced spine course, all hands on.

A previous course focused on basic science, cell harvesting, etc. I haven't done that one, but I would like to at some point (my practice pays for me to learn) because I really am not the guy to be able to sit and debate whether or not this stuff works. I haven't started doing this in my practice yet, but as I work it in I will start with either facet/SIJ PRP or the ligamentous PRP (superspinous, interspinous, iliolumbar, SI ligaments).

The rationale behind the ligamentous therapy makes sense to me IN THEORY, but no one has really been able to explain how it works other than to say, "If you have spondylosis and SIJ pain, think of all of this as a motion segment and if you tighten and strengthen up all these ligaments you can stabilize degenerative listhesis (no one claims to reverse it), possibly spinal stenosis (the LF is a continuation of the interspinous ligament so that seems like something to consider if by tightening the IS ligament you can pull back on the LF), and improve SIJ pain (sort of weird to consider SIJ pain and treat it like we do knee OA considering it is overwhelmingly stable and buried by tons of ligaments and rarely shows any radiographic change despite it hurting).

They recommend against intradiscal therapy unless that pt has failed everything and meets very specific criteria. The instructors I met do not do intradiscal SC very often.

These courses are expensive. Mine was $2200.

 

[cowboydoc]

What is there to be skeptical of?

Herniated Disc - Regenexx

www.regenexx.com

"The final option is often an extremely invasive spinal fusion in which two discs are joined permanently together with hardware."

Did a naturopathic nurse chiropractic practicioner write this?

 

[lobelsteve]

"The final option is often an extremely invasive spinal fusion in which two discs are joined permanently together with hardware."

Did a naturopathic nurse chiropractic practicioner write this?

Common pathway should be acceptance that there is no currently good treatment and not fusion.

 

[Ducttape]

cant market that, tho, dr. pulseless

 

[lobelsteve]

Dr. Gudin has seen patients improve remarkably with PRP and stem cell injections, “and have even considered the injections myself,” he said. “However, anecdotal case reports and bias by uncontrolled studies should not guide practice.”

From a payor perspective, Dr. Gudin said interventional pain physicians are often thought of as cost centers. “Therefore, when offering patients stem cell therapies for all of their painful ailments, let’s hope that clinicians do not exploit this therapy, similar to the ‘liquid gold’ of urine drug testing, ambulatory surgical center fees, in-house pharmacies and egregiously priced compounded topical analgesics,” he said.
Dr. Gudin commended the authors for providing guidelines as a baseline for future updates. As a physician who struggles to treat patients with refractory low back pain, he looks forward to the day when higher levels of evidence will be available for these biologic treatments.
Roland Staud, MD, a professor of medicine at the University of Florida in Gainesville, said the ASIPP guidelines in general are nothing new to pain specialists. “But these basic guidelines are a benefit because they support the use of regenerative medicine using appropriate precautions,” he said.
However, Dr. Staud, who is also a member of the Pain Medicine News editorial advisory board, believes that most of the regenerative medicine therapies should be evaluated in a research setting, where there is a controlled environment. “These guidelines are based on limited evidence, in a field that is very difficult to study and where only few effective therapies are available,” he said. “Also, because the pain mechanisms of many patients differ considerably, individually targeted therapy will be most effective.”
To translate these new techniques into clinical practice requires cautious application of regenerative therapy, according to Dr. Staud. “Each clinician needs to decide for himself the risk and benefit because the effectiveness of these therapies is often minimal or lacking,” he said.
He also pointed out that the application of some of the regenerative therapies may be driven by financial interests, which gives him pause as to their true benefits.

 

[drusso]

I'm going to inject actual mooshoo, but gluten free. Data supports it. Anecdotal, imaginary data.

Semmelweis reflex - Wikipedia

en.wikipedia.org

 

[Ducttape]

Can you truly invoke an argument such as a Semmelweis Reflex when you don’t actually have evidence based medicine as your foundation?

 

[drusso]

Can you truly invoke an argument such as a Semmelweis Reflex when you don’t actually have evidence based medicine as your foundation?

Which evidence do you dispute? Are you saying there is no scientific foundation to wound care and tissue healing?

 

[lobelsteve]

Get good free advertising.

New stem cell therapy uses patients' own stem cells to help rebuild tissue

Doctors at the Andrews Institute in Gulf Breeze are now using stem cell therapy to treat certain injuries, and they're the first in the area to do it. Brandon Osborn is one of their patients. WEAR. Osborn has been playing competitive tennis is whole life, but two years ago he was sidelined by...

weartv.com

The doc could not say how much it cost but said it was expensive. Then said needed more research.

Human experimentation went from prisoners to making bank.

 

[drusso]

Get good free advertising.

New stem cell therapy uses patients' own stem cells to help rebuild tissue

Doctors at the Andrews Institute in Gulf Breeze are now using stem cell therapy to treat certain injuries, and they're the first in the area to do it. Brandon Osborn is one of their patients. WEAR. Osborn has been playing competitive tennis is whole life, but two years ago he was sidelined by...

weartv.com

The doc could not say how much it cost but said it was expensive. Then said needed more research.

Human experimentation went from prisoners to making bank.

MILES study will be game-changer.

ClinicalTrials.gov

clinicaltrials.gov

 

[drusso]

MILES study will be game-changer.

ClinicalTrials.gov

clinicaltrials.gov

There are the centers currently enrolling patients...

Contacts

Contact: Kenneth Mautner, MD

404-778-7142

[email protected]

Locations

United States, Florida
Andrews Institute	Recruiting
Gulf Breeze, Florida, United States, 32561
Contact: Joshua G Hackel, MD 850-916-8783
United States, Georgia
The Emory Clinic	Recruiting
Atlanta, Georgia, United States, 30322
Contact: Kenneth Mautner, MD 404-778-7142 [email protected]
United States, North Carolina
Duke University	Recruiting
Durham, North Carolina, United States, 27710
Contact: Blake Boggess, DO 919-681-9525 [email protected]
United States, North Dakota
Sanford Health	Recruiting
Fargo, North Dakota, United States, 58103
Contact: Benjamin Noonan 605-312-6020
United States, South Dakota
Sanford Health	Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Chad Kurtenbach, MD 605-312-6020

Sponsors and Collaborators

 

[SommeRiver]

I worked with Mautner during residency. Great dude.

 

[deleted993114]

Guys I was thinking about adding Regenerative medicine to my practice. Really don’t know where to start. Need some input from others who are in this space.
Maybe just start with PRP and go from there.
Do’s and Dont’s.
Any and all advice is appreciated.

Thanks.


Sent from my iPhone using SDN mobile

I think if you offer it, consider it to be a marketing strategy rather than a very effective treatment alternative.

There is a fear of being passe and not offering the "latest and greatest" treatments, vs being conservative and objectively evaluating new treatments carefully. I have been "snake bit" by PRP, IDET, decompressor, nucleoplasty, and pulsed radiofrequency to name a few. Afterwards, you feel like an idiot for having done them.

Even though, in my experience in the past, PRP does not work, there is little downside to it (with the exception of infection). I think if you present it as currently an experimental treatment and explain the pros and cons, there is nothing wrong with offering it. WIth expanded use of this treatment, there will be more and more providers who can share their experience. I've been there, done that, and really don't want to do it again, but for others who have never done it, it could be an eye opening experience.

Keep in mind that the placebo rate increases the more a patient pays out of pocket for a treatment; perhaps that is at work here. There was an interesting basic science article in PAIN that showed nociceptive mediators of pain released from platelets, thus producing an inflammatory response and supposed increase pain. One can take that for what it is worth.

 

[deleted993114]

There are the centers currently enrolling patients...

Contacts

Contact: Kenneth Mautner, MD

404-778-7142

[email protected]

Locations

United States, Florida
Andrews Institute	Recruiting
Gulf Breeze, Florida, United States, 32561
Contact: Joshua G Hackel, MD 850-916-8783
United States, Georgia
The Emory Clinic	Recruiting
Atlanta, Georgia, United States, 30322
Contact: Kenneth Mautner, MD 404-778-7142 [email protected]
United States, North Carolina
Duke University	Recruiting
Durham, North Carolina, United States, 27710
Contact: Blake Boggess, DO 919-681-9525 [email protected]
United States, North Dakota
Sanford Health	Recruiting
Fargo, North Dakota, United States, 58103
Contact: Benjamin Noonan 605-312-6020
United States, South Dakota
Sanford Health	Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Chad Kurtenbach, MD 605-312-6020

Sponsors and Collaborators

Indeed- large scale well conducted studies. Everyone has their personal biases about what is effective and what is not. Such studies will help guide treatments to minimize the reliance on anecdotes.

Regarding PRP (not stem cells), I would like to wrong, as any new effective treatment is welcome. I would certainly change my position with further well done studies and am by no means entrenched in my views.

 

[deleted993114]

Do you foresee regenerative medicine becoming covered by insurance in the next 5-10 years?

No way in hell.

I did work for Blue Cross (jesus Christ; come to think of it, I have worn several different hats!) in the past on their review committee for new procedures/technology. The bar is set pretty high for welcoming new treatments/technology. They are by no means closed minded, but really require several randomized, double blinded, placebo controlled studies with good statistics to accept as new treatments. I really don't think that PRP or stem cells will be "ready for prime time" in the near future. Could be wrong, but doubt it.

Along a similar note, despite Medicare considering covering acupuncture, given the current data, there is no way in hell that the Blues will be covering it.

Further, IF commercial payers covered those treatments, keep in mind that there is "one bucket" of cash allocated for expenditures to each specialty area. If there is a massive increase in the use of one treatment, expect dramatic cuts in reimbursement for other procedures. It is like robbing Peter to pay Paul. Those who do PRP and stem cells may NEVER want such treatments covered, as they prefer the cash only basis of those treatments.

Let's see what happens when more studies are done by legitimate docs (not the ones selling and promoting the technology). Time will tell.

 

[drusso]

No way in hell.

I did work for Blue Cross (jesus Christ; come to think of it, I have worn several different hats!) in the past on their review committee for new procedures/technology. The bar is set pretty high for welcoming new treatments/technology. They are by no means closed minded, but really require several randomized, double blinded, placebo controlled studies with good statistics to accept as new treatments. I really don't think that PRP or stem cells will be "ready for prime time" in the near future. Could be wrong, but doubt it.

Along a similar note, despite Medicare considering covering acupuncture, given the current data, there is no way in hell that the Blues will be covering it.

Further, IF commercial payers covered those treatments, keep in mind that there is "one bucket" of cash allocated for expenditures to each specialty area. If there is a massive increase in the use of one treatment, expect dramatic cuts in reimbursement for other procedures. It is like robbing Peter to pay Paul. Those who do PRP and stem cells may NEVER want such treatments covered, as they prefer the cash only basis of those treatments.

Let's see what happens when more studies are done by legitimate docs (not the ones selling and promoting the technology). Time will tell.

Politics, not evidence, will delay its broader acceptance. Some groups are working with individual employer groups to get specific "steering language" added to self-insured plans summaries of benefit authorizing trials of orthobiologics (PRP/BMAC) for orthopedic conditions prior to expensive surgery at HOPD's. It's an uphill battle. Some see the value proposition and some don't. At the end of the day, the results and savings will speak for themselves.

 

[Ducttape]

I currently dispute that you have irrefutable evidence to state that stem cell therapy is beneficial. we are not having reflex tendency towards the potential for stem cell therapy. you do not have sufficient EBM yet to support your contention that stem cell therapy is beneficial?

when this study comes out, that will go much further to support EBM for stem cell benefit... or it will never get published.



fwiw, it might help if you stopped posting infomercials from regenexx. imo, it isn't becoming of your status as a thought leader.

 

[drusso]

I currently dispute that you have irrefutable evidence to state that stem cell therapy is beneficial. we are not having reflex tendency towards the potential for stem cell therapy. you do not have sufficient EBM yet to support your contention that stem cell therapy is beneficial?

when this study comes out, that will go much further to support EBM for stem cell benefit... or it will never get published.

fwiw, it might help if you stopped posting infomercials from regenexx. imo, it isn't becoming of your status as a thought leader.

All evidence is refutable unless it's Mu-Shoo Magic...

You don't know what the evidence is and what it is not for regenerative medicine.

Even infomercials contain evidence.

Your dispute is dismissed without prejudice.

 

[oreosandsake]

How is your experience with Regenexx? I’ve heard variable things. Does a lot of the money for the procedure end up going to them?

I have a partner who does stem cell injections but he sends to a surgeon who does the adipose extraction then sends the cells and some PRP back to him to actually inject. Technically, the patient pays the surgeon for the stem cell treatment and the surgeon pays my partner to do the injection. I would want to do it all myself though if I end up offering it. I’m just not sure I really believe in it enough to suggest it to patients - even the outcomes on Regenexx’s own website aren’t that impressive in terms of %pain relief...

this is NOT allowed per the FDA. where does your partner work? whistleblowing = $$ ?


FDA has guidance re "same day, same site of service"
your partner is not adhering to it if he/she is calling this stem cells

someone asked "why go to a course"

well, you need to get training somewhere. and ideally, you find responsible, ethical people who believe in evidence based medicine to teach you. otherwise, you are committing fraud in many ways, selling nonsense to your patients, and a great disservice to the field.

 

[NOSfan]

Or just make crap up as you go. But marketing is key. View attachment 259685

My patient attended one of these and MINUS $5,000 later is left with a hard movable gumball size mass on the bottom of his foot. He says it's like 'walking on a rock.'

 

[oreosandsake]

How is your experience with Regenexx? I’ve heard variable things. Does a lot of the money for the procedure end up going to them?

I have a partner who does stem cell injections but he sends to a surgeon who does the adipose extraction then sends the cells and some PRP back to him to actually inject. Technically, the patient pays the surgeon for the stem cell treatment and the surgeon pays my partner to do the injection. I would want to do it all myself though if I end up offering it. I’m just not sure I really believe in it enough to suggest it to patients - even the outcomes on Regenexx’s own website aren’t that impressive in terms of %pain relief...

f

 

[oreosandsake]

https://www.fda.gov/media/89920/download

 

[Ducttape]

All evidence is refutable unless it's Mu-Shoo Magic...

You don't know what the evidence is and what it is not for regenerative medicine.

Even infomercials contain evidence.

Your dispute is dismissed without prejudice.

if you cannot post valid level 1 or even level 2 EBM based studies that show a clinically significant benefit of stem cell compared to usual therapy and placebo, then you have no grounds to stand on either.

don't tell me to just believe what you or Regenexx says is the "Word of Regenexx God". ive heard that line too many times before. as I have said over 1000 times, post the data so we doctors and scientists can really critique it and come to our own conclusions in a scientific manner that may advance science.


infomercials are not required to have evidence, especially unbiased reproducible evidence.

don't let stem cells be like cold laser, spinal decompression, acupuncture, etc...

 

[drusso]

if you cannot post valid level 1 or even level 2 EBM based studies that show a clinically significant benefit of stem cell compared to usual therapy and placebo, then you have no grounds to stand on either.

don't tell me to just believe what you or Regenexx says is the "Word of Regenexx God". ive heard that line too many times before. as I have said over 1000 times, post the data so we doctors and scientists can really critique it and come to our own conclusions in a scientific manner that may advance science.


infomercials are not required to have evidence, especially unbiased reproducible evidence.

don't let stem cells be like cold laser, spinal decompression, acupuncture, etc...

I just walked out of a room from seeing a 66-year-old competitive quilter who I did a thumb PRP injection in 8 weeks ago. 0-1/10 pain. She's out of her splint and occupational therapy has released her back to training without restrictions. Ortho-hand wanted to do a $40,000 arthroplasty which would have been a career-ending event for her. She's feeling optimistic about her tournament in Helsinki this October and feels like she's ready to compete with "the big girls" again this year.

I can't even remember why you think this is controversial...

Biomed Res Int. 2016;2016:9262909. doi: 10.1155/2016/9262909. Epub 2016 Jul 5.
Leukocyte-Reduced Platelet-Rich Plasma Treatment of Basal Thumb Arthritis: A Pilot Study.
Loibl M1, Lang S1, Dendl LM2, Nerlich M1, Angele P1, Gehmert S3, Huber M1.
Author information

Abstract
A positive effect of intra-articular platelet-rich plasma (PRP) injection has been discussed for osteoarthritic joint conditions in the last years. The purpose of this study was to evaluate PRP injection into the trapeziometacarpal (TMC) joint. We report about ten patients with TMC joint osteoarthritis (OA) that were treated with 2 intra-articular PRP injections 4 weeks apart. PRP was produced using the Double Syringe System (Arthrex Inc., Naples, Florida, USA). A total volume of 1.47 ± 0.25 mL PRP was injected at the first injection and 1.5 ± 0.41 mL at the second injection, depending on the volume capacity of the joint. Patients were evaluated using VAS, strength measures, and the Mayo Wrist score and DASH score after 3 and 6 months. VAS significantly decreased from 6.2 ± 1.6 to 5.4 ± 2.2 at six-month follow-up (P < 0.05). The DASH score was unaffected; however, the Mayo Wrist score significantly improved from 46.5 ± 18.6 to 67.5 ± 19.0 at six-month follow-up (P = 0.05). Grip was unaffected, whereas pinch declined from 6.02 ± 2.99 to 3.96 ± 1.77 at six-month follow-up (P < 0.05). We did not observe adverse events after the injection of PRP, except one occurrence of a palmar wrist ganglion, which resolved without treatment. PRP injection for symptomatic TMC OA is a reasonable therapeutic option in early stages TMC OA and can be performed with little to no morbidity.

 

[Ducttape]

is PRP = stem cell?

if you reread my recent posts, i have explicitly asked for more data on stem cell. and in a previous posts, i did laud a study for PRP for tendonitis. all while noting that most of my patients have poor protoplasm for PRP.

 

[lobelsteve]

Anecdotes does not equal anecdata.

 

[drusso]

is PRP = stem cell?

if you reread my recent posts, i have explicitly asked for more data on stem cell. and in a previous posts, i did laud a study for PRP for tendonitis. all while noting that most of my patients have poor protoplasm for PRP.

What do you think CAUSED the healing to occur??? Magic?? Acupuncture?? CBT??? How are platelets proteins going to EFFECT anything unless they interact with some kind of living cellular tissue matrix or substrate...BTW, I've tried just waving PRP over patients boo-boo's and it doesn't work. You have to actually inject it into damaged tissue and cause a cellular reaction.

Sports Health. 2019 Jul/Aug;11(4):355-366. doi: 10.1177/1941738119834972. Epub 2019 May 28.

Impact of Platelet-Rich Plasma Use on Pain in Orthopaedic Surgery: A Systematic Review and Meta-analysis.
Johal H1, Khan M1, Yung SP2, Dhillon MS3, Fu FH4, Bedi A5, Bhandari M1.
Author information

Abstract
CONTEXT:
Amid extensive debate, evidence surrounding the use of platelet-rich plasma (PRP) for musculoskeletal injuries has rapidly proliferated, and an overall assessment of efficacy of PRP across orthopaedic indications is required.
OBJECTIVES:
(1) Does PRP improve patient-reported pain in musculoskeletal conditions? and (2) Do PRP characteristics influence its treatment effect?
DATA SOURCES:
MEDLINE, EMBASE, Cochrane, CINAHL, SPORTDiscus, and Web of Science libraries were searched through February 8, 2017. Additional studies were identified from reviews, trial registries, and recent conferences.
STUDY SELECTION:
All English-language randomized trials comparing platelet-rich therapy with a control in patients 18 years or older with musculoskeletal bone, cartilage, or soft tissue injuries treated either conservatively or surgically were included. Substudies of previously reported trials or abstracts and conference proceedings that lacked sufficient information to generate estimates of effect for the primary outcome were excluded.
STUDY DESIGN:
Systematic review and meta-analysis.
LEVEL OF EVIDENCE:
Level 1.
DATA EXTRACTION:
All data were reviewed and extracted independently by 3 reviewers. Agreement was high between reviewers with regard to included studies.
RESULTS:
A total of 78 randomized controlled trials (5308 patients) were included. A standardized mean difference (SMD) of 0.5 was established as the minimum for a clinically significant reduction in pain. A reduction in pain was associated with PRP at 3 months (SMD, -0.34; 95% CI, -0.48 to -0.20) and sustained until 1 year (SMD, -0.60; 95% CI, -0.81 to -0.39). Low- to moderate-quality evidence supports a reduction in pain for lateral epicondylitis (SMD, -0.69; 95% CI, -1.15 to -0.23) and knee osteoarthritis (SMD, -0.91; 95% CI, -1.41 to -0.41) at 1 year. PRP characteristics did not influence results.
CONCLUSION:
PRP leads to a reduction in pain; however, evidence for clinically significant efficacy is limited. Available evidence supports the use of PRP in the management of lateral epicondylitis as well as knee osteoarthritis.
KEYWORDS:
arthritis; growth factor; orthopaedics; platelet-rich plasma; regenerative medicine; sports medicine

 

[lobelsteve]

What do you think CAUSED the healing to occur??? Magic?? Acupuncture?? CBT??? How are platelets proteins going to EFFECT anything unless they interact with some kind of living cellular tissue matrix or substrate...BTW, I've tried just waving PRP over patients boo-boo's and it doesn't work. You have to actually inject it into damaged tissue and cause a cellular reaction.

Sports Health. 2019 Jul/Aug;11(4):355-366. doi: 10.1177/1941738119834972. Epub 2019 May 28.

Impact of Platelet-Rich Plasma Use on Pain in Orthopaedic Surgery: A Systematic Review and Meta-analysis.
Johal H1, Khan M1, Yung SP2, Dhillon MS3, Fu FH4, Bedi A5, Bhandari M1.
Author information

Abstract
CONTEXT:
Amid extensive debate, evidence surrounding the use of platelet-rich plasma (PRP) for musculoskeletal injuries has rapidly proliferated, and an overall assessment of efficacy of PRP across orthopaedic indications is required.
OBJECTIVES:
(1) Does PRP improve patient-reported pain in musculoskeletal conditions? and (2) Do PRP characteristics influence its treatment effect?
DATA SOURCES:
MEDLINE, EMBASE, Cochrane, CINAHL, SPORTDiscus, and Web of Science libraries were searched through February 8, 2017. Additional studies were identified from reviews, trial registries, and recent conferences.
STUDY SELECTION:
All English-language randomized trials comparing platelet-rich therapy with a control in patients 18 years or older with musculoskeletal bone, cartilage, or soft tissue injuries treated either conservatively or surgically were included. Substudies of previously reported trials or abstracts and conference proceedings that lacked sufficient information to generate estimates of effect for the primary outcome were excluded.
STUDY DESIGN:
Systematic review and meta-analysis.
LEVEL OF EVIDENCE:
Level 1.
DATA EXTRACTION:
All data were reviewed and extracted independently by 3 reviewers. Agreement was high between reviewers with regard to included studies.
RESULTS:
A total of 78 randomized controlled trials (5308 patients) were included. A standardized mean difference (SMD) of 0.5 was established as the minimum for a clinically significant reduction in pain. A reduction in pain was associated with PRP at 3 months (SMD, -0.34; 95% CI, -0.48 to -0.20) and sustained until 1 year (SMD, -0.60; 95% CI, -0.81 to -0.39). Low- to moderate-quality evidence supports a reduction in pain for lateral epicondylitis (SMD, -0.69; 95% CI, -1.15 to -0.23) and knee osteoarthritis (SMD, -0.91; 95% CI, -1.41 to -0.41) at 1 year. PRP characteristics did not influence results.
CONCLUSION:
PRP leads to a reduction in pain; however, evidence for clinically significant efficacy is limited. Available evidence supports the use of PRP in the management of lateral epicondylitis as well as knee osteoarthritis.
KEYWORDS:
arthritis; growth factor; orthopaedics; platelet-rich plasma; regenerative medicine; sports medicine

however, evidence for clinically significant efficacy is limited.


Magic. Or power of therapeutic interaction. Or cellular mechanism.


sci·en·tif·ic meth·od
noun

1. a method of procedure that has characterized natural science since the 17th century, consisting in systematic observation, measurement, and experiment, and the formulation, testing, and modification of hypotheses.
   "criticism is the backbone of the scientific method"

 

[hyperalgesia]

There needs to be a mission among govt employed docs to DISPROVE new treatments. Everybody now just wants to justify CPT codes.

It's a horrible mockery of science.