Evidence for Stem Cells?

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DrCommonSense

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Going off the thread noted by another poster pertaining to the guy who was promoting proper "injection techniques" for stem cells, I have a more fundamental question.

What evidence is there for stem cells for soft tissue damage and osteoarthritis in particular?

I see some studies on DDD that was in Phase 3 trials for mesoblast but what about other applications?

Also, what evidence is the "Regenexx" system is superior to other stem cell systems?

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n = 30 RCT published last year: "The single intraarticular injection of in vitro expanded autologous BM-MSCs together with HA is a safe and feasible procedure that results in a clinical and functional improvement of knee OA, especially when 100 × 10(6) cells are administered."

The Healing Effects Of Bone-Marrow Derived Stem Cells in Knee Osteoarthritis: A Case Report: "Twelve months after cell transplantation, the WOMAC changed from 3 to 2, and the VAS from 80 mm to 11 mm. This modification for walking ability was 170 m before and 700 m after treatment and for the number of stairs to climb for the pain to appear was 5 stairs before and 50 stairs after therapy. The time till the appearance of gelling was 8 min and reached to 30 min and the knee flexion was 100° and improved to 120° twelve months after cell transplantation. The patellar crepitus was 3 before and 2 after therapy. After 6 months, the MRI of the right knee revealed an increase in thickness of the covering cartilage in distal condyle of the femur and the proximal part of the tibia (Figure 4A-C). These changes were much more significant after 12 months follow up (Figure 4D-F)."

Treatment of Knee Osteoarthritis with Autologous Mesenchymal Stem Cells: A Pilot Study: "MSC therapy may be a valid alternative treatment for chronic knee osteoarthritis. The intervention is simple, does not require hospitalization or surgery, provides pain relief, and significantly improves cartilage quality."

A few more:

Long-Term Follow-up of Intra-articular Injection of Autologous Mesenchymal Stem Cells in Patients with Knee, Ankle, or Hip Osteoarthritis. - PubMed - NCBI
Combination of intra-articular autologous activated peripheral blood stem cells with growth factor addition/ preservation and hyaluronic acid in co... - PubMed - NCBI
Intra-articular injection of mesenchymal stem cells for the treatment of osteoarthritis of the knee: a proof-of-concept clinical trial. - PubMed - NCBI
Increased knee cartilage volume in degenerative joint disease using percutaneously implanted, autologous mesenchymal stem cells. - PubMed - NCBI

Some of these studies have been criticized, perhaps validly, for not specifying whether or how the subjects were blinded.

Centeno of Regenexx published this overview of the research a few days ago: https://www.regenexx.com/wp-content...ons-Timeline-Centeno-April-2017-update-V5.pdf
 
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I'm more interested in evidence for hairloss....
 
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n = 30 RCT published last year: "The single intraarticular injection of in vitro expanded autologous BM-MSCs together with HA is a safe and feasible procedure that results in a clinical and functional improvement of knee OA, especially when 100 × 10(6) cells are administered."

The Healing Effects Of Bone-Marrow Derived Stem Cells in Knee Osteoarthritis: A Case Report: "Twelve months after cell transplantation, the WOMAC changed from 3 to 2, and the VAS from 80 mm to 11 mm. This modification for walking ability was 170 m before and 700 m after treatment and for the number of stairs to climb for the pain to appear was 5 stairs before and 50 stairs after therapy. The time till the appearance of gelling was 8 min and reached to 30 min and the knee flexion was 100° and improved to 120° twelve months after cell transplantation. The patellar crepitus was 3 before and 2 after therapy. After 6 months, the MRI of the right knee revealed an increase in thickness of the covering cartilage in distal condyle of the femur and the proximal part of the tibia (Figure 4A-C). These changes were much more significant after 12 months follow up (Figure 4D-F)."

Treatment of Knee Osteoarthritis with Autologous Mesenchymal Stem Cells: A Pilot Study: "MSC therapy may be a valid alternative treatment for chronic knee osteoarthritis. The intervention is simple, does not require hospitalization or surgery, provides pain relief, and significantly improves cartilage quality."

A few more:

Long-Term Follow-up of Intra-articular Injection of Autologous Mesenchymal Stem Cells in Patients with Knee, Ankle, or Hip Osteoarthritis. - PubMed - NCBI
Combination of intra-articular autologous activated peripheral blood stem cells with growth factor addition/ preservation and hyaluronic acid in co... - PubMed - NCBI
Intra-articular injection of mesenchymal stem cells for the treatment of osteoarthritis of the knee: a proof-of-concept clinical trial. - PubMed - NCBI
Increased knee cartilage volume in degenerative joint disease using percutaneously implanted, autologous mesenchymal stem cells. - PubMed - NCBI

Some of these studies have been criticized, perhaps validly, for not clarifying whether or how the subjects were blinded.

Centeno of Regenexx published this overview of the research a few days ago: https://www.regenexx.com/wp-content...ons-Timeline-Centeno-April-2017-update-V5.pdf

I dont see any evidence that Regenexx is better than other methods.

I also don't see any information on how long each injection lasts for or if it prevents worsening of OA.
 
I dont see any evidence that Regenexx is better than other methods.

I'm not aware of any studies comparing Regenexx against other methods. The question defies common sense. Why does Regenexx have to prove their superiority? What evidence is there that other methods are superior to Regenexx? What evidence is there that whatever therapies you rely on to treat OA are superior to Regenexx or stem cell procedures in general?

I also don't see any information on how long each injection lasts for or if it prevents worsening of OA.

The results likely vary with cell source, number, the joint treated, and post-procedure activity restrictions. The 2016 knee arthritis RCT I posted showed the most improvement occurred in the first three months, and this improvement was maintained at 12 months. This paper studied patients with knee, hip, and ankle OA and showed peak improvement at 12 months and a slight decline at 30 months. Most if not all studies show that the procedure arrests the disease progression.

https://oup.silverchair-cdn.com/oup...1euzWd0eIQ__&Key-Pair-Id=APKAIUCZBIA4LVPAVW3Q
"Moreover, the radiographic scores of the hip joint(s), assessed on a time period ranging from 7 to 30 months after cell infusion, clearly demonstrate a halt in the progression of osteoarthritis."
 
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I'm not aware of any studies comparing Regenexx against other methods. The question defies common sense. Why does Regenexx have to prove their superiority? What evidence is there that other methods are superior to Regenexx? What evidence is there that whatever therapies you rely on to treat OA are superior to Regenexx or stem cell procedures in general?



The results likely vary with cell source, number, the joint treated, and post-procedure activity restrictions. The 2016 knee arthritis RCT I posted showed the most improvement occurred in the first three months and were preserved at 12 months. This paper studied knee, hip, and ankle subjects and showed peak improvement at 12 months and a slight decline at 30 months. Most if not all studies show that the procedure arrests the disease progression.

https://oup.silverchair-cdn.com/oup...1euzWd0eIQ__&Key-Pair-Id=APKAIUCZBIA4LVPAVW3Q
"Moreover, the radiographic scores of the hip joint(s), assessed on a time period ranging from 7 to 30 months after cell infusion, clearly demonstrate a halt in the progression of osteoarthritis."


The discussion in the other thread was about Centino, so I looked up his company and its "Regenexx". When you read about it, he constantly claims he can "concentrate" cells far better than others and has superior results but I can't ever find studies.

If this stops "disease" progression but lasts only 7 months, does that mean you have to inject these every 7 months? Isn't that very expensive compared to other options?

Also what does it mean by "stop disease progression"? Does that mean it doesn't go from moderate to severe OA ever or it slows it down by a few years at very high cost that might not be cost effective?
 
The discussion in the other thread was about Centino, so I looked up his company and its "Regenexx". When you read about it, he constantly claims he can "concentrate" cells far better than others and has superior results but I can't ever find studies.

If this stops "disease" progression but lasts only 7 months, does that mean you have to inject these every 7 months? Isn't that very expensive compared to other options?

Also what does it mean by "stop disease progression"? Does that mean it doesn't go from moderate to severe OA ever or it slows it down by a few years at very high cost that might not be cost effective?

Centeno claims to have mastered techniques to concentrate platelets, not cells, and to maximize cell yield from a BMA. This is based on his company's own research over a period of 10-15 years. I don't think denouncing him as a charlatan for not publishing proof is a credible position. To my knowledge he doesn't make claims about how his results compare to those of others, but his company (Regenexx) is the only group making an effort to track patient outcomes, and is also responsible for publishing a large portion of the world's literate on orthopedic stem cell procedures.

All evidence to date, much of which exists thanks to Centeno, suggests the benefits last much longer than 7 months. While the improvements peak at a certain point, that doesn't mean the patient is then back to pre-treatment status; one treatment can bring years of relief. The patient might benefit from additional treatments over time, but if cost is a limiting factor, one treatment is still better than none.

Your remarks about cost-effectiveness are simply stupid. Any mention of cost effectiveness is meaningless unless expressed in relation to the cost of other options. Not cost effective COMPARED TO WHAT? Relying on NSAIDs, which are firmly proven to accelerate disease progression and triple or quadruple your risk of a heart attack or stroke? A prescription for Celebrex can easily run $4000-5000 a year for a patient with no insurance. OA is also the leading cause of disability in the US; is it more cost-effective to leave your OA untreated until you lose the ability to work? A knee replacement procedure runs $50,000. The health complications of enforced inactivity can lead to yet more medical expenses. Given that stem cell therapy is the only known disease-modifying treatment for OA in existence, it's the most expensive option to go without in terms of the cost to one's health, quality of life, and ability to earn a living. For that reason, most rational, intelligent people with the money to do so are willing to pay a few thousand dollars for a treatment.
 
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Centeno claims to have mastered techniques to concentrate platelets, not cells, and to maximize cell yield from a BMA. This is based on his company's own research over a period of 10-15 years. I don't think denouncing him as a charlatan for not publishing proof is a credible position. To my knowledge he doesn't make claims about how his results compare to those of others, but his company (Regenexx) is the only group making an effort to track patient outcomes, and is also responsible for publishing a large portion of the world's literate on orthopedic stem cell procedures.

All evidence to date, much of which exists thanks to Centeno, suggests the benefits last much longer than 7 months. While the improvements peak at a certain point, that doesn't mean the patient is then back to pre-treatment status; one treatment can bring years of relief. The patient might benefit from additional treatments over time, but if cost is a limiting factor, one treatment is still better than none.

Your remarks about cost-effectiveness are simply stupid. Any mention of cost effectiveness is meaningless unless expressed in relation to the cost of other options. Not cost effective COMPARED TO WHAT? Relying on NSAIDs, which are firmly proven to accelerate disease progression and triple or quadruple your risk of a heart attack or stroke? A prescription for Celebrex can easily run $4000-5000 a year for a patient with no insurance. OA is also the leading cause of disability in the US; is it more cost-effective to leave your OA untreated until you lose the ability to work? A knee replacement procedure runs $50,000. The health complications of enforced inactivity can lead to yet more medical expenses. Given that stem cell therapy is the only known disease-modifying treatment for OA in existence, it's the most expensive option to go without in terms of the cost to one's health, quality of life, and ability to earn a living. For that reason, most rational, intelligent people with the money to do so are willing to pay a few thousand dollars for a treatment.

wow, that's a lot of unfounded claims you are making here! Stem cell therapy is the ONLY KNOWN DISEASE-MODIFYING treatment for OA in existence? and Cost-Effectiveness analysis is "simply stupid"?

To my knowledge, I have not heard any company (stem cells or not) to claim they have found a disease-modifying treatment for OA that has such a high success rate that effectiveness of the treatment is in no doubt, and therefore the cost is no concern...
 
wow, that's a lot of unfounded claims you are making here! Stem cell therapy is the ONLY KNOWN DISEASE-MODIFYING treatment for OA in existence? and Cost-Effectiveness analysis is "simply stupid"?

To my knowledge, I have not heard any company (stem cells or not) to claim they have found a disease-modifying treatment for OA that has such a high success rate that effectiveness of the treatment is in no doubt, and therefore the cost is no concern...

Too many straw men, not worthy of a response.
 
Centeno claims to have mastered techniques to concentrate platelets, not cells, and to maximize cell yield from a BMA. This is based on his company's own research over a period of 10-15 years. I don't think denouncing him as a charlatan for not publishing proof is a credible position. To my knowledge he doesn't make claims about how his results compare to those of others, but his company (Regenexx) is the only group making an effort to track patient outcomes, and is also responsible for publishing a large portion of the world's literate on orthopedic stem cell procedures.

All evidence to date, much of which exists thanks to Centeno, suggests the benefits last much longer than 7 months. While the improvements peak at a certain point, that doesn't mean the patient is then back to pre-treatment status; one treatment can bring years of relief. The patient might benefit from additional treatments over time, but if cost is a limiting factor, one treatment is still better than none.

Your remarks about cost-effectiveness are simply stupid. Any mention of cost effectiveness is meaningless unless expressed in relation to the cost of other options. Not cost effective COMPARED TO WHAT? Relying on NSAIDs, which are firmly proven to accelerate disease progression and triple or quadruple your risk of a heart attack or stroke? A prescription for Celebrex can easily run $4000-5000 a year for a patient with no insurance. OA is also the leading cause of disability in the US; is it more cost-effective to leave your OA untreated until you lose the ability to work? A knee replacement procedure runs $50,000. The health complications of enforced inactivity can lead to yet more medical expenses. Given that stem cell therapy is the only known disease-modifying treatment for OA in existence, it's the most expensive option to go without in terms of the cost to one's health, quality of life, and ability to earn a living. For that reason, most rational, intelligent people with the money to do so are willing to pay a few thousand dollars for a treatment.

A) Didn't know that stem cells were proven to be a "disease modifying" treatment for OA. Do you have confirmation of the degree of "disease modification" such as before and after pictures? Do these cells make severe OA into moderate OA or moderate in mild OA?

The Healing Effect of Bone Marrow-Derived Stem Cells in Knee Osteoarthritis: A Case Report. - PubMed - NCBI

This is largely just a case report that claims some VAS benefit and "MRI revealed an extension of the repaired tissue over subchondral bone.". What does that even mean for the MRI findings?

Where are the bigger trials of many patients showing significant morphological changes? Why only sparse case reports?

Also that level of "modification" might not be clinically significant long term in terms of prevention of TKRs in the future.

Also, all those benefits don't sound any better than visco, which appears far cheaper than stem cells.

B) Also by your logic of a 50K cost for total knee replacement that could last 10 to 15 years would come out to be approximately 5K/year in costs. Are stem cell treatments less than 5000 per year?

C) Also, what studies do you have that stem cell treatments prevent future surgeries and in which patients? Does it prevent mild, moderate and severe OA patients from having surgeries? How many surgeries are minimized from this treatment at what cost? So I guess I will compare stem cells to TKR.
 
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dont forgot the income lost from the surgery and rehab, vs no loss of either with regenerative tx's
 
dont forgot the income lost from the surgery and rehab, vs no loss of either with regenerative tx's

Is there evidence that stem cells prevent surgery more than visco or even simple steroid injections?
 
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irreproducibility by others suggests that the therapy is either too young in its maturation to be used or, more likely, that it is more "snake oil" than anything else. Others need to be able to reproduce his results, otherwise one is viewing a placebo effect or observer bias (or something more reprehensible).


Btw, there are indices that are used to determine treatment efficacy vs cost, such a QALY.


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Centeno of Regenexx published this overview of the research a few days ago: https://www.regenexx.com/wp-content...ons-Timeline-Centeno-April-2017-update-V5.pdf

This is a really great slide. Thanks for sharing. And thanks for Dr Centeno for putting together. I don't know enough about the available research to know if he is cherry picking articles that support his thesis - I hope it isn't as that would totally discredit everything he says, does, or publishes. Dishonesty is a horrible stain that way.
 
This is a really great slide. Thanks for sharing. And thanks for Dr Centeno for putting together. I don't know enough about the available research to know if he is cherry picking articles that support his thesis - I hope it isn't as that would totally discredit everything he says, does, or publishes. Dishonesty is a horrible stain that way.

I don't think Centeno is cherry-picking favorable data the way his detractors here cherry-pick the negative. The slide includes every study I've been able to find on my own over a two year period. He also readily admits the limitations of stem cell procedures and the reality of treatment failure in a significant percentage of patients in everything he writes. I see no evidence of dishonesty.
 
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A) Didn't know that stem cells were proven to be a "disease modifying" treatment for OA. Do you have confirmation of the degree of "disease modification" such as before and after pictures? Do these cells make severe OA into moderate OA or moderate in mild OA?

Yes there is radiological evidence of improved cartilage quality and thickness following treatment with stem cells. This was included among the studies I posted. I’ll reiterate a few:
  • Intra-articular injection of mesenchymal stem cells for the treatment of osteoarthritis of the knee: a proof-of-concept clinical trial (May 2014)
    • N = 18 (3 groups)
    • "Histology demonstrated thick, hyaline-like cartilage regeneration. These results showed that intra-articular injection of 1.0 × 10(8) AD MSCs into the osteoarthritic knee improved function and pain of the knee joint without causing adverse events, and reduced cartilage defects by regeneration of hyaline-like articular cartilage."
    • "Kellgren-Lawrence grade, joint space width, mechanical axis,and anatomical axis did not change significantly over 6 months in all dose groups (Supporting Information Table 4). Serial MRI examinations found gradual regeneration of articular cartilage in the medial femoral and tibial condyles over 6 months (Fig. 3A)."
    • "As a gold standard for articular cartilage assessment, arthroscopy before and 6 months after AD MSCs injection demonstrated findings consistent with clinical and radiological outcomes. Macroscopically, regenerated cartilage formed in the most severely degenerated area with ICRS grade 3 in the medial femoral and tibial condyles, whereas it was hardly seen in the less severely degenerated area in the lateral compartment and the patella (Fig. 4A–4C). Regenerated cartilage looked glossy white with a smooth surface. With a probe, it felt firm like healthy articular cartilage in the medial femoral condyle, whereas it was less firm in the medial tibial condyle. No loose body, hypertrophy, or abnormal calcification was identified."

  • Increased Knee Cartilage Volume in Degenerative Joint Disease using Percutaneously Implanted, Autologous Mesenchymal Stem Cells (2008)
    • "At 24 weeks post-injection, the patient had statistically significant cartilage and meniscus growth on MRI, as well as increased range of motion and decreased modified VAS pain scores."
Where are the bigger trials of many patients showing significant morphological changes? Why only sparse case reports?

There are published trials involving dozens of patients. The reason there aren’t more and bigger published trials yet is because the regulatory environment in the U.S. makes trials involving cultured cells (which are likely needed for cartilage repair) cost prohibitive. One of the favorite tactics of those hostile to stem cell medicine is to pretend they can't understand how this works.

Also, all those benefits don't sound any better than visco, which appears far cheaper than stem cells.

Cartilage regeneration doesn’t sound better than HA? Almost unimaginably stupid statement. Besides the evidence proves you wrong. Lamo-Espinosa et al. used HA as in their control group in the n = 30 that demonstrated the effectiveness of both low and high dose stell cell injections:

“The patients that were solely given HA did not show changes during follow up in their pain status according to VAS (Fig. 2; Additional file 3: Table S1). Furthermore, although they initially perceived some improvement according to the WOMAC pain and physical function subscores, this perception was not significantly sustained in the long term (Table 2). Inatraarticular delivery of BM-MSCs, specially when used at high dose, enabled patients to perceive an improvement in their perception of pain in their daily activity. On one hand, the VAS score value was significantly reduced upon treatment with low and high BM-MSC doses at all follow-up times (Fig. 2; Additional file 3: Table S1). Furthermore, treatment with 100 × 106 cells was associated with a significant improvement in all WOMAC subscores at 12 months (Table 2).“

B) Also by your logic of a 50K cost for total knee replacement that could last 10 to 15 years would come out to be approximately 5K/year in costs. Are stem cell treatments less than 5000 per year?

To my knowledge $3000 - $5000 is a common price range for same day stem cell treatments. But comparing joint replacement with stem cell therapy on a dollar for dollar basis is just stupid. Regenerating articular cartilage is obviously a far superior and more desirable outcome than amputating the joint.

C) Also, what studies do you have that stem cell treatments prevent future surgeries and in which patients? Does it prevent mild, moderate and severe OA patients from having surgeries? How many surgeries are minimized from this treatment at what cost? So I guess I will compare stem cells to TKR.

I don’t know of any studies that have tracked this metric; I'm not saying they don't exist just that I haven't paid attention. I know Centeno does track this with his registry data and has published the most recent data on his site somewhere but I don’t think it compares the stem cell treatment with a control group.
 
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study #1 - not blinded. essentially a case series. 28% failure rate. researchers stated this was level 4 evidence.

study #2 - a much better study. randomized, but why use hyaluronidase and bone marrow? the volumes were different in all 3 groups (4ml for HA alone, 5.5 for the low dose BM-MSC, and 7ml for high dose). they also used pelvic bone marrow to culture the cells. and I do not see anywhere that "control patients" had BM biopsy done - doesn't specifically state. if not, then possible observer bias/patient bias? also, why do the WOMAC pain scores not correlate with VAS pain scores (in the WOMAC data, it notes that HA group had pain reduction similar to BM-MSC groups, but not VAS). overall, not a bad study, small in size. best of the bunch, but still limited in size and has some questionable decisions by the researchers.

study #3 - case report. laden with observer bias.

study #4 - you forgot to include the statement before that which you chose to post, in particular: " All patients were partly satisfied with the results of the study. Pain, functional status of the knee, and walking distance tended to be improved up to six months post-injection, after which pain appeared to be slightly increased and patients' walking abilities slightly decreased."

study #5 - a pilot study only.

study #6 - small group as before, but this time, lets do a bunch of different sites all over the body!! that will be different, and prove that BM-MSC works!

interestingly, this same Iranian group applied for a clinical study for OA of hip, in 2011, that was apparently completed but never reported (maybe because it failed?)... Mesenchymal Stem Cell Transplantation in Osteoarthritis of Hip Joint - No Study Results Posted - ClinicalTrials.gov


study #7 - adding another therapy - not only HA, or BM/MSC, but ALSO LETS DO SOME DRILLING!!! 5 patients, like all the other studies besides #2, not blinded, not controlled. not randomized.

study #8 - only high dose group had benefit at 6 months out...

long and short - double blinded randomized trial comparing BM-MSC with HA and with sham injection is what is most evidentiary...
 
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The whole problem with stem cells (as I see it) is stem cell engraftment.

Why would a stem cell, who went swimming by the knee a day before and said to himself - "nope, don't need to stop or do anything here today" - who is then taken from his environment, placed in the knee (or around it - because to be honest, if you aren't doing these under ultrasound for fluoro, you miss more than half the time), now say " wow. I was just here yesterday and didn't stay but I will today!" It wouldn't. It would just swim away. ( I assume stem cells are males for some reason). And that is what anyone that has looked at the issue has noticed - that stem cells injected usually end up dead or in the spleen shortly after injection. I suspect people don't look what happens more often because they don't really want to know the answer.
 
MSCs dont "swim," they adhere to the surface onto which they are placed
 
is that why the one study included microdrilling at time of implantation?

make more damage to get the stem cells to heal that new damage and repair old damage...
 
study #1 - not blinded. essentially a case series. 28% failure rate. researchers stated this was level 4 evidence.

study #2 - a much better study. randomized, but why use hyaluronidase and bone marrow? the volumes were different in all 3 groups (4ml for HA alone, 5.5 for the low dose BM-MSC, and 7ml for high dose). they also used pelvic bone marrow to culture the cells. and I do not see anywhere that "control patients" had BM biopsy done - doesn't specifically state. if not, then possible observer bias/patient bias? also, why do the WOMAC pain scores not correlate with VAS pain scores (in the WOMAC data, it notes that HA group had pain reduction similar to BM-MSC groups, but not VAS). overall, not a bad study, small in size. best of the bunch, but still limited in size and has some questionable decisions by the researchers.

study #3 - case report. laden with observer bias.

study #4 - you forgot to include the statement before that which you chose to post, in particular: " All patients were partly satisfied with the results of the study. Pain, functional status of the knee, and walking distance tended to be improved up to six months post-injection, after which pain appeared to be slightly increased and patients' walking abilities slightly decreased."

study #5 - a pilot study only.

study #6 - small group as before, but this time, lets do a bunch of different sites all over the body!! that will be different, and prove that BM-MSC works!

interestingly, this same Iranian group applied for a clinical study for OA of hip, in 2011, that was apparently completed but never reported (maybe because it failed?)... Mesenchymal Stem Cell Transplantation in Osteoarthritis of Hip Joint - No Study Results Posted - ClinicalTrials.gov


study #7 - adding another therapy - not only HA, or BM/MSC, but ALSO LETS DO SOME DRILLING!!! 5 patients, like all the other studies besides #2, not blinded, not controlled. not randomized.

study #8 - only high dose group had benefit at 6 months out...

long and short - double blinded randomized trial comparing BM-MSC with HA and with sham injection is what is most evidentiary...

They need a double blinded RCT with a large number of patients comparing BM-MSC vs HA over 1 year

I would also like to see a comparison trial between TKR for mild to moderate OA vs BM-MSC. Wonder if BM-MSC can actually prevent TKR or not. That is important as well.
 
MSCs dont "swim," they adhere to the surface onto which they are placed

Prove it. Because when others have tried and tagged them - they seem to "swim" to the spleen, or die after transplantation.

The do "swim". They float around the blood stream after they are created. How do you think they get around? Are you supposing they magically appear in the target destination?
 
Definitely need more high quality studies otherwise no insurance will ever cover it. Until then people will need to risk their own resources using available data and their doctor's expertise to guide them.
 
study #1 - not blinded. essentially a case series. 28% failure rate. researchers stated this was level 4 evidence.

study #2 - a much better study. randomized, but why use hyaluronidase and bone marrow? the volumes were different in all 3 groups (4ml for HA alone, 5.5 for the low dose BM-MSC, and 7ml for high dose). they also used pelvic bone marrow to culture the cells. and I do not see anywhere that "control patients" had BM biopsy done - doesn't specifically state. if not, then possible observer bias/patient bias? also, why do the WOMAC pain scores not correlate with VAS pain scores (in the WOMAC data, it notes that HA group had pain reduction similar to BM-MSC groups, but not VAS). overall, not a bad study, small in size. best of the bunch, but still limited in size and has some questionable decisions by the researchers.

study #3 - case report. laden with observer bias.

study #4 - you forgot to include the statement before that which you chose to post, in particular: " All patients were partly satisfied with the results of the study. Pain, functional status of the knee, and walking distance tended to be improved up to six months post-injection, after which pain appeared to be slightly increased and patients' walking abilities slightly decreased."

study #5 - a pilot study only.

study #6 - small group as before, but this time, lets do a bunch of different sites all over the body!! that will be different, and prove that BM-MSC works!

interestingly, this same Iranian group applied for a clinical study for OA of hip, in 2011, that was apparently completed but never reported (maybe because it failed?)... Mesenchymal Stem Cell Transplantation in Osteoarthritis of Hip Joint - No Study Results Posted - ClinicalTrials.gov


study #7 - adding another therapy - not only HA, or BM/MSC, but ALSO LETS DO SOME DRILLING!!! 5 patients, like all the other studies besides #2, not blinded, not controlled. not randomized.

study #8 - only high dose group had benefit at 6 months out...

long and short - double blinded randomized trial comparing BM-MSC with HA and with sham injection is what is most evidentiary...

These comments are mostly out of context. You asked specifically for before and after pictures demonstrating OA disease modification and I posted exactly that. In my original post I granted that many of these studies have a risk of bias in terms of the patients' self-reported pain results, but these problems are sorely inadequate to discredit the radiological, histological, and arthoscopic findings of cartilage regeneration. So what if one of the dozen-odd studies I posted involved drilling—microfracture has been done for decades and never been shown to effect global surface repair.

Bottom line is that despite their shortcomings, these studies are the best evidence in existence that OA can be medically addressed in any meaningful way. The conventional paradigm of NSAIDs, steroids, HA, PT, and surgery is an absymal failure, and medicine is culpable for not having a better solution to such a horrible and widespread health problem. A 28% failure rate is a 72% higher success rate than anything you're doing now.
 
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These comments are mostly out of context. You asked specifically for before and after pictures demonstrating OA disease modification and I posted exactly that. In my original post I granted that many of these studies have a risk of bias in terms of the patients' self-reported pain results, but these problems are sorely inadequate to discredit the radiological, histological, and arthoscopic findings of cartilage regeneration. So what if one of the dozen-odd studies I posted involved drilling—microfracture has been done for decades and never been shown to effect global surface repair.

Bottom line is that despite their shortcomings, these studies are the best evidence in existence that OA can be medically addressed in any meaningful way. The conventional paradigm of NSAIDs, steroids, HA, PT, and surgery is an absymal failure, and medicine is culpable for not having a better solution to such a horrible and widespread health problem. A 28% failure rate is a 72% higher success rate than anything you're doing now.

I dont disagree with the last part.

But I fear that the addition of stem cells at this point will just change the algorithim to NSAIDs, steroids, HA, PT, then Stem Cells and then Surgery with just vastly increased costs.
 
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He's talking about the insurance model not some cash based niche surgery center in oklahoma. That is FAR from the norm.

On average, cost of a TKR is 49,500 in the USA just for the hospital charge. With surgical fees, anesthesia fees, etc add in another 10K or so with an average around 58K. Add in post TKR rehab and thats another 3K or so. So its closer to >60K on average with the current insurance model: Understanding Knee Replacement Costs: What's on the Bill?

He is also right about the costs of celebrex for people WITH insurance. Sure you could get a "hardship" benefit but on average celebrex is 1000s per year (worse for Lyrica)
 
He's talking about the insurance model not some cash based niche surgery center in oklahoma. That is FAR from the norm.

On average, cost of a TKR is 49,500 in the USA just for the hospital charge. With surgical fees, anesthesia fees, etc add in another 10K or so with an average around 58K. Add in post TKR rehab and thats another 3K or so. So its closer to >60K on average with the current insurance model: Understanding Knee Replacement Costs: What's on the Bill?

He is also right about the costs of celebrex for people WITH insurance. Sure you could get a "hardship" benefit but on average celebrex is 1000s per year (worse for Lyrica)
Read the celebrex link I posted, anyone can use that - insured, uninsured, Medicare, Medicaid.

There is a group in my town that does knee replacement for 25k inclusive. They also take insurance, but that's their cash price.
 
Read the celebrex link I posted, anyone can use that - insured, uninsured, Medicare, Medicaid.

There is a group in my town that does knee replacement for 25k inclusive. They also take insurance, but that's their cash price.

What about postop rehab after surgery and postop management?
 
What about postop rehab after surgery and postop management?
Post op surgeon care included.

There's a PT group in town that's $100 per session, cash. I don't know the specifics of post-op knee therapy, but let's pretend 3X/week for a month so add 1.2k to that.
 
These comments are mostly out of context. You asked specifically for before and after pictures demonstrating OA disease modification and I posted exactly that. In my original post I granted that many of these studies have a risk of bias in terms of the patients' self-reported pain results, but these problems are sorely inadequate to discredit the radiological, histological, and arthoscopic findings of cartilage regeneration. So what if one of the dozen-odd studies I posted involved drilling—microfracture has been done for decades and never been shown to effect global surface repair.

Bottom line is that despite their shortcomings, these studies are the best evidence in existence that OA can be medically addressed in any meaningful way. The conventional paradigm of NSAIDs, steroids, HA, PT, and surgery is an absymal failure, and medicine is culpable for not having a better solution to such a horrible and widespread health problem. A 28% failure rate is a 72% higher success rate than anything you're doing now.

No. You are wrong. I never asked for anything.

I critiqued poorly designed "studies" that, with 1 exception, really do not "qualify" to be considered good EBM.

There is greater EBM for genicular nerve block +/- RFA at present...


I hope I don't have to remind you that Medicine is not "at fault" for anything. We are looking for cures for conditions that are occurring because we now have a blessedly long life. When "God" decides that it is time for humanity to find a way to deal with these chronic illnesses, EBM should be at the forefront of introducing/presenting such treatments.

Fwiw despite what our radiology colleagues state, images do not determine degree of dysfunction or level of pain. Having remodeling cannot be used as a determinant of pain reduction. Ask any post fusion patient...


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No. You are wrong. I never asked for anything.

I critiqued poorly designed "studies" that, with 1 exception, really do not "qualify" to be considered good EBM.

There is greater EBM for genicular nerve block +/- RFA at present...


I hope I don't have to remind you that Medicine is not "at fault" for anything. We are looking for cures for conditions that are occurring because we now have a blessedly long life. When "God" decides that it is time for humanity to find a way to deal with these chronic illnesses, EBM should be at the forefront of introducing/presenting such treatments.

Fwiw despite what our radiology colleagues state, images do not determine degree of dysfunction or level of pain. Having remodeling cannot be used as a determinant of pain reduction. Ask any post fusion patient...


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I agree with all of that stuff except the anti God statement and that remodeling isn't really important by implication.

I think its VERY important to show morphological improvement and/or prevention of progression of disease for stem cells. The big selling point about stem cells is that it CURES disease.
 
So to reclarify my point, remodeling is important only if there is a direct correlation to clinical improvement.

And your other aspect - I was trying to be politically correct.


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Check this journal, entire content dedicated to regenerative medicine, some good articles for review.
Physical Medicine and Rehabilitation Clinics of North America, 2016-11-01, Volume 27, Issue 4,
 
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