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All clinically significant efficacy is limited...
Adding Regenerative medicine to your practice.
- Thread starter bronchospasm
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All clinically significant efficacy is limited...
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you quoted this article before.
low to moderate evidence from what you have previously derided as GIGO study method.
I can understand quoting this study for low-moderate evidence for lateral epicondylitis or knee osteoarthritis and I'm pretty sure I said so before.
but... where do stem cells fit in? I'm not seeing where they comment about where the stem cells were harvested, treated then injected. I mean I read the book you recommended.
Amazon product
isn't PRP using a patient's whole blood, spinning them down, and then injecting platelets and growth factors? isn't stem cell therapy where they harvest immature cells, bathe them in some sort of solution, and then inject them in hopes that the cells will differentiate in to new cells? I'm not sure, but they sound different to me. are you stating that they are the same?
low to moderate evidence from what you have previously derided as GIGO study method.
I can understand quoting this study for low-moderate evidence for lateral epicondylitis or knee osteoarthritis and I'm pretty sure I said so before.
but... where do stem cells fit in? I'm not seeing where they comment about where the stem cells were harvested, treated then injected. I mean I read the book you recommended.
Amazon product
isn't PRP using a patient's whole blood, spinning them down, and then injecting platelets and growth factors? isn't stem cell therapy where they harvest immature cells, bathe them in some sort of solution, and then inject them in hopes that the cells will differentiate in to new cells? I'm not sure, but they sound different to me. are you stating that they are the same?
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What you call "Stem cell therapy" is a misnomer and a marketing term and as such, I have no idea what it means when others use that term. A lot of times what unqualified practitioners such as yourself call "stem cell therapy" is injecting no more than amniotic-derived tissue products (dead baby dust shots) into patients without image guidance and bilking them for thousands of dollars.
In my practice, I inject autologous bone marrow aspirate concentrate (BMAC) for focal cartilage pathology and moderate to severe tendinopathy more or less following the original protocols developed by Herignou in France in the 80's and further modified and developed by Centeno more recently. As you know, and probably ideologically approve, France is a socialized health system and Herignou did not personally "profit" from his breakthroughs except for academic merit and speaking engagements. Others inject micro-fragmented adipose tissue (Lipogems) using an FDA-cleared device. Again, not certain either tissue product qualifies for what you call "stem cell therapies."
In my mind, they are both autologous tissue grafts procedure and not "stem cell therapy." I don't think you'll ever persuade me otherwise.
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Are you saying BMAC and Lipogems shouldn’t be advertised as stem cell therapy? Regenexx and your own website refer to the treatments you offer as Stem Cells. Or are you saying that if a consumer goes out and buys a stem cell treatment they may get any of dozens of products, many of which do not contain stem cells, while the services you sell do?
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exactly. yet you wonder why there is doubt as to the veracity of stem cell therapy.
from what I have read in that book you suggested, I am making a clear distinction from the use of mesenchymal stromal cells or stem cells withdrawn either from various places of a patients body or "donated" from some stem cell line, with a solution containing a greater than normal number of platelets.
page 15 and 22.
page 24.
imo, PRP - there is some low to moderate level evidence for benefit in certain clinical situations, particularly musculoskeletal.
Stem cell - have yet to see evidence.
I'm not an expert, so I don't know what I'm talking about, but please... I'm asking you to post evidence about MSC ie stem cell therapy, as you advocate for "stem cell therapy", but I keep reading conflation with PRP...
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Both. "Stem cell therapy" is a disputed term even among Regenex doctors, but there is unescapable colloquialism. I prefer "cellular therapy" as I believe that this term more scientifically describes the paracrine and reparative mechanisms purported to be in effect for these treatments. More generally, the whole notion of "stemness" is contested among molecular-cellular biologists.
Call to Stop Using the Term “Mesenchymal Stem Cell”
Critics say the misleading term actually refers to a heterogeneous population of cells, including possible tissue-specific progenitor cells and nonstem cells all lumped together.
www.the-scientist.com
More germane to discussion is the idea that if a person going to hold themselves out as a scientific critic of technology, then they shouldn't locker-room banter/marketing lingo and instead use terms that are agreed to and recognizable.
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Application of mesenchymal stem cell therapy for the treatment of osteoarthritis of the knee: A concise review
Osteoarthritis (OA) refers to a chronic joint disease characterized by degenerative changes of articular cartilage and secondary bone hyperplasia. Since articular cartilage has a special structure, namely the absence of blood vessels as well as the low ...
www.ncbi.nlm.nih.gov
Stem Cells Transl Med. 2019 Jul 21. doi: 10.1002/sctm.18-0285. [Epub ahead of print]
Functional Outcomes Following Microfragmented Adipose Tissue Versus Bone Marrow AspirateConcentrate Injections for Symptomatic Knee Osteoarthritis.
Mautner K1,2, Bowers R1,2, Easley K3, Fausel Z2, Robinson R1.
Author information
Abstract
This study aimed to determine whether autologous orthobiologic tissue source affects pain and functional outcomes in patients with symptomatic knee osteoarthritis (OA) who received microfragmented adipose tissue (MFAT) or bone marrow aspirate concentrate (BMAC) injection. We retrospectively reviewed prospectively collected data from patients who received BMAC or MFAT injection for symptomatic knee OA. Patients completed baseline and follow-up surveys. Each survey included the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire, Emory Quality of Life (EQOL) questionnaire, and Visual Analog Scale (VAS) for pain. The follow-up responses were compared with baseline for all patients and between BMAC and MFAT groups. A total of 110 patients met inclusion criteria, with 76 patients (BMAC 41, MFAT 35) and 106 knees (BMAC 58, MFAT 48) having appropriate follow-up data. The BMAC group included 17 females and 24 males, with a mean age of 59 ± 11. The MFAT group included 23 females and 12 males, with a mean age of 63 ± 11. Minimum follow-up time was 0.5 years. Mean follow-up time was 1.80 ± 0.88 years for BMAC and 1.09 ± 0.49 years for MFAT. Both groups had significant improvement in EQOL, VAS, and all KOOS parameters preprocedure versus postprocedure (p < .001). There was not a significant difference when comparing postprocedure scores between groups (p = .09, .38, .63, .94, .17, .15, .70, respectively). These data demonstrate significant improvement in pain and function with both MFAT and BMAC injections in patients with symptomatic knee OA without a significant difference in improvement when comparing the two autologous tissue sources. Stem Cells Translational Medicine 2019.
© 2019 The Authors. Stem Cells Translational Medicine published by Wiley Periodicals, Inc. on behalf of AlphaMed Press.
KEYWORDS:
Adipose; Adipose stem cells; Adult stem cells; Arthritis; Bone marrow; Mesenchymal stem cells; Stem cells
Orthop J Sports Med. 2016 Jan 13;4(1):2325967115625481. doi: 10.1177/2325967115625481. eCollection 2016 Jan.
Concentrated Bone Marrow Aspirate for the Treatment of Chondral Injuries and Osteoarthritis of the Knee: A Systematic Review of Outcomes.
Chahla J1, Dean CS1, Moatshe G2, Pascual-Garrido C3, Serra Cruz R4, LaPrade RF5.
Author information
Abstract
BACKGROUND:
Bone marrow aspirate concentrate (BMAC) has emerged as a novel treatment for pathology of the knee. Despite containing a limited number of stem cells, BMAC serves as a source of growth factors that are thought to play an important role as a result of their anabolic and anti-inflammatory effects. To our knowledge, there is no systematic review regarding the outcomes of bone marrow aspirateconcentrate used for the treatment of chondral defects and osteoarthritis of the knee.
PURPOSE:
To perform a systematic review on the outcomes of bone marrow aspirate concentrate for the treatment of chondral defects and osteoarthritis of the knee.
STUDY DESIGN:
Systematic review; Level of evidence, 4.
METHODS:
A systematic review of the literature was performed using the Cochrane Database of Systematic Reviews, the Cochrane Central Register of Controlled Trials, PubMed, and MEDLINE from 1980 to present. Inclusion criteria were as follows: use of BMAC for treatment of chondral defects and osteoarthritis of the knee, English language, and human studies. We excluded cadaveric studies, animal studies, basic science articles, editorial articles, surveys, and studies that did not include the knee. After applying inclusion and exclusion criteria, studies were evaluated for efficacy and safety of BMAC for treatment of articular cartilage knee pathologies.
RESULTS:
Eleven studies were considered. Of these, 5 were prospective studies, 1 was a retrospective study, 2 were case series, and 3 were case reports. Three comparative studies (2 with level 2 evidence, 1 with level 3 evidence) were found in our search; none of them were randomized. Three studies investigated the clinical efficacy of BMAC in the treatment of osteoarthritis, and 8 studies evaluated the efficacy of BMAC on focal cartilage injuries. All 3 studies regarding osteoarthritis and all 8 studies regarding focal chondral defects reported good to excellent overall outcomes with the use of BMAC.
CONCLUSION:
Although a growing interest for biological alternatives of treating knee pathology has been observed in the past few years, there still remains a paucity of high-quality studies. The studies included in this systematic review reported varying degrees of beneficial results with the use of BMAC with and without an additional procedure for the treatment of chondral defects and early stages of osteoarthritis. Most articles present the use of BMAC as a safe procedure and report good results.
KEYWORDS:
BMAC; bone marrow aspirate concentrate; cartilage; knee; regenerative therapy; systematic review
Arthroscopy. 2019 Jun;35(6):1860-1877. doi: 10.1016/j.arthro.2018.11.073. Epub 2019 Mar 11.
The Role of Bone Marrow Aspirate Concentrate for the Treatment of Focal Chondral Lesions of the Knee: A Systematic Review and Critical Analysis of Animal and Clinical Studies.
Cavinatto L1, Hinckel BB2, Tomlinson RE3, Gupta S4, Farr J5, Bartolozzi AR4.
Author information
Abstract
PURPOSE:
To summarize currently available data regarding the use of bone marrow aspirate concentrate (BMAC) for the treatment of focal chondral lesions of the knee in experimental animal models and human clinical studies.
METHODS:
A systematic review searching for the terms "(bone marrow)" AND "(aspirate OR concentrate)" AND "(cartilage OR chondral OR osteochondral)" was performed in the databases PubMed, Cochrane Central Register of Controlled Trials, and Google Scholar regarding the use of BMAC for the treatment of focal chondral lesions of the knee. The inclusion criteria were animal and clinical studies published in English that used autologous BMAC to treat focal chondral defects of the knee. We excluded studies that evaluated nonconcentrated preparations of bone marrow aspirate or preparations that were culture expanded.
RESULTS:
A total of 23 studies were included: 10 studies performed in animal models and 13 human clinical studies. Animal studies showed inconsistent outcomes regarding the efficacy of BMAC for the treatment of chondral or osteochondral lesions, assessed by gross morphology, second-look arthroscopy, magnetic resonance imaging, histology, immunohistochemistry, mechanical testing, and micro-tomography. Chondral defect filling was achieved with fibrocartilage or "hyaline-like" cartilage. Cells present in BMAC did not meet the criteria to be characterized as mesenchymal stem cells according to the International Society for Cell Therapy because freshly isolated cells failed to show tri-lineage differentiation. Overall, all clinical studies, independent of the study group or level of evidence, reported improved clinical outcomes and higher macroscopic, magnetic resonance imaging, and histology scores. Comparative trials favored BMAC over microfracture and reported equivalent outcomes between BMAC and matrix-induced autologous chondrocyte implantation. However, clinical studies were scant and showed low scientific rigor, poor methodologic quality, and low levels of evidence on average.
CONCLUSIONS:
Although clinical success in short-term and midterm applications has been suggested for the application of BMAC for the restoration of cartilage defects in lesions of the knee, current study designs are generally of low scientific rigor. In addition, clinical applications of this technology in animal model investigations have shown inconsistent outcomes. Thus, clinicians should apply this technology cautiously.
LEVEL OF EVIDENCE:
Level IV, systematic review of Level II, III, and IV evidence studies.
Copyright © 2019 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.
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these are a good start. but they are primarily level 4 evidence. even the studies posted are all phase I/II, to show if there is a suggestion for efficacy. none of these these are Phase III studies that determine extent of efficacy
article 1. nice review. table 1 - data appear to be in sheep and dog model. table 2 - case series, limited evidence. table 3 - best study is the first, a few of the others used hyaluronidase as control. unfortunately for the Gupta study - not clinically significant. the Matas study did show improvement in pain (not MRI score) compared to hyaluronidase, but I don't think it was blinded, but results of umbilical derived MSC for knee arthritis is positive. Phase I/II study. Song study has promising results, but the abstract doesn't confirm it was blinded and no control and only 18 patients. cant read article... costs $$$.
article 2. comparing fat derived cell injection with bone marrow derived cell injection does not further whether MSCs help compared to placebo injection. this may be totally placebo effect. worthless study for our discussion standpoint.
article 3. systemic review, level 4 evidence per the authors. 11 studies in 26 years looked at is pretty low numbers to base clinical decision making. in addition, "Eleven studies were considered. Of these, 5 were prospective studies, 1 was a retrospective study, 2 were case series, and 3 were case reports. Three comparative studies (2 with level 2 evidence, 1 with level 3 evidence) were found in our search; none of them were randomized... "Although a growing interest for biological alternatives of treating knee pathology has been observed in the past few years, there still remains a paucity of high-quality studies. The studies included in this systematic review reported varying degrees of beneficial results." so even these positive studies did not show stem cells to be highly beneficial.
article 4. another systemic review, this time mixing in (conflating) animal and human studies to make something positive I guess. take home points:
However, clinical studies were scant and showed low scientific rigor, poor methodologic quality and low levels of evidence on average.
Thus, clinicians should apply this technology cautiously.
article 1. nice review. table 1 - data appear to be in sheep and dog model. table 2 - case series, limited evidence. table 3 - best study is the first, a few of the others used hyaluronidase as control. unfortunately for the Gupta study - not clinically significant. the Matas study did show improvement in pain (not MRI score) compared to hyaluronidase, but I don't think it was blinded, but results of umbilical derived MSC for knee arthritis is positive. Phase I/II study. Song study has promising results, but the abstract doesn't confirm it was blinded and no control and only 18 patients. cant read article... costs $$$.
article 2. comparing fat derived cell injection with bone marrow derived cell injection does not further whether MSCs help compared to placebo injection. this may be totally placebo effect. worthless study for our discussion standpoint.
article 3. systemic review, level 4 evidence per the authors. 11 studies in 26 years looked at is pretty low numbers to base clinical decision making. in addition, "Eleven studies were considered. Of these, 5 were prospective studies, 1 was a retrospective study, 2 were case series, and 3 were case reports. Three comparative studies (2 with level 2 evidence, 1 with level 3 evidence) were found in our search; none of them were randomized... "Although a growing interest for biological alternatives of treating knee pathology has been observed in the past few years, there still remains a paucity of high-quality studies. The studies included in this systematic review reported varying degrees of beneficial results." so even these positive studies did not show stem cells to be highly beneficial.
article 4. another systemic review, this time mixing in (conflating) animal and human studies to make something positive I guess. take home points:
However, clinical studies were scant and showed low scientific rigor, poor methodologic quality and low levels of evidence on average.
Thus, clinicians should apply this technology cautiously.
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I apply all new technologies cautiously...Why be indiscriminate?
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id ask that you be discriminate.
in my opinion only, insufficient evidence right now, with no Phase III studies to review (ie no sufficient EBM to review), to advocate for MSC.
so far, review of 10 phase 3 completed studies posted on clinicaltrials.gov does not look favorably on PRP either... but ill keep looking.
in my opinion only, insufficient evidence right now, with no Phase III studies to review (ie no sufficient EBM to review), to advocate for MSC.
so far, review of 10 phase 3 completed studies posted on clinicaltrials.gov does not look favorably on PRP either... but ill keep looking.
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What else do you do in your practice absent Phase III clinical studies---CBT, Acupunture, ESI's?
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We should all be aware that there is basically only bad evidence for virtually everything we do except encourage people to stop smoking.
Even the all-mighty knee steroid:
www.niams.nih.gov
www.ncbi.nlm.nih.gov
Even the all-mighty knee steroid:
Long-term Benefit of Steroid Injections for Knee Osteoarthritis Challenged
Among people with osteoarthritic knees, repeated steroid injections over two years brought no lon
Corticosteroid injections for osteoarthritis of the knee: meta-analysis
Objectives To determine the efficacy of intra-articular corticosteroid injections for osteoarthritis of the knee and to identify numbers needed to treat.Data sources Cochrane controlled trials register, Medline (1966 to 2003), Embase (1980 to 2003), hand ...
www.ncbi.nlm.nih.gov
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We should all be aware that there is basically only bad evidence for virtually everything we do except encourage people to stop smoking.
Even the all-mighty knee steroid:
Long-term Benefit of Steroid Injections for Knee Osteoarthritis Challenged
Among people with osteoarthritic knees, repeated steroid injections over two years brought no lonCorticosteroid injections for osteoarthritis of the knee: meta-analysis
Objectives To determine the efficacy of intra-articular corticosteroid injections for osteoarthritis of the knee and to identify numbers needed to treat.Data sources Cochrane controlled trials register, Medline (1966 to 2003), Embase (1980 to 2003), hand ...
There is pretty good evidence for exercise, remaining active, stimulators, and cervical rf.
However, just because there is poor evidence for many old treatments does not mean that one should embrace new technology with poor evidence.
I have been really surprised at how PRP (not stem cells, but along the "regenerative medicine" line) has been so widely embraced with so little evidence. It is characteristic of pain management in general. and has led to the whole field having less credibility.
We used PRP only in the spine and it was a complete bust. I think that much of the enthusiasm is financially motivated. I hope that randomized, double blinded, prospective studies show benefit; however, I am skeptical, given the experience we had in the past with it. If it was the magic bullet that everyone says, we would have seen very dramatic, good results. We did not, thus it was abandoned.
When embracing treatments from Europe, one must understand that Europe has been the home of many dubious treatments that, when examined carefully, do not work.
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as you know, I focus more on quality of life issues and functionality than purely on pain reduction. you can do the best injection in the world and take away 99% of a patient's pain but they are still "suffering from pain"...
clinical trials do not involve CBT and pain psychology - if I remember correctly, clinical trials are for drugs and devices. and it is difficult doing double blind placebo controlled studies on psychological treatment. there is definitely no $$$ involved.
for ESI, much more problematic, especially regarding lumbar spinal stenosis. I did consider completely phasing out ESI as the some recent studies such as LESS suggest no benefit (this study was discussed previously in 2014 when it came out in NEJM), and it fits in this Medical Reversal model you mentioned above. in fact, there are studies dating as far back as 1985 regarding lack of efficacy of ESI in spinal stenosis.
however, radiculopathy from disc herniation has much more EBM to support than spinal stenosis.
some studies have identified MILD as being more effective for lumbar spinal stenosis than ESI...
clinical trials do not involve CBT and pain psychology - if I remember correctly, clinical trials are for drugs and devices. and it is difficult doing double blind placebo controlled studies on psychological treatment. there is definitely no $$$ involved.
for ESI, much more problematic, especially regarding lumbar spinal stenosis. I did consider completely phasing out ESI as the some recent studies such as LESS suggest no benefit (this study was discussed previously in 2014 when it came out in NEJM), and it fits in this Medical Reversal model you mentioned above. in fact, there are studies dating as far back as 1985 regarding lack of efficacy of ESI in spinal stenosis.
however, radiculopathy from disc herniation has much more EBM to support than spinal stenosis.
some studies have identified MILD as being more effective for lumbar spinal stenosis than ESI...
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Agree. I only do ESI for radiculopathy, and thus do much much fewer of them than most people I know.
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there are no magic bullets. I agree that we need to be cautious when approached by new interventions.
there is a lot of evidence for PRP. an incredible amount actually. from all over the world. level 1 prospective RCTs. It just depends on the indication you are treating. there are positive studies, and there are negative studies. there are studies published in JAMA and NEJM.
corticosteroid injections - PubMed - NCBI 16750 when you type in "corticosteroid injections"
platelet rich plasma - PubMed - NCBI there are nearly 11000 hits just using this one search engine.
the problem with these treatments is that people want to point and shoot and collect $. there is a lot that goes into the practice of medicine. You cannot dabble in spinal cord stimulators, you cannot dabble in obstretrics or neurosurgery... but a lot of docs don't spend the time to study the science, get beyond minimal proficiency, but want to make a quick buck making big promises and marketing themselves as regen experts.
they get a cheap 5 ml blood draw prp kit, and have the rep teach them how to spin the blood, and then they expect pixie dust in the syringe.
then they go about their usual pixie dust practices --> just like how people put corticosteroids into everything, they start putting PRP into everything, everywhere, in anyone who has money to pay. there are selection criteria for interventions beyond, "does this person have cash"
I don't know what your experience is, or how much time you put into learning about regen med, but there is hardly any evidence for PRP in the spine. scant evidence. low level studies. Why did you choose this application?
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This is what was advocated in the mid 90s. Like all stuff back then, we were squirting odd things into discs and facet joints; such PRP treatment was promoted back then and, as useful idiots, we tried it out. The "training" was what the experts at the time showed you at the meeting. Keep in mind that pain management was much smaller and there were only about 100 guys or so tops at a national meeting.
Thus the "choice" of discs and facets. It seemed to work quite poorly and was thus abandoned. I do not recall anyone trying it on peripheral joints or ligaments.
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maybe it's worth taking another look at it again for peripheral msk applications.
there are a lot of variables that can change the outcomes. spine still has poor data.
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Maybe so. Again, we did it for facets and discs. I understand that Mayo has had some promising preliminary data on peripheral ligamentous disorders. Perhaps it will prove to be a beneficial treatment for those cases- if so, that would be great.
I rarely see such patients, but I think that may be a reasonable application. The good thing is that this is becoming more widely used, such that we can expect more good studies to show the benefits (or not) one way or another.
I must say that I was disappointed with the results in the facets and discs. We had a nurse back then who tracked all of our outcomes independently, so it helped eliminate observer bias (we all tend to perhaps think things work better in our hands than maybe they actually do) and it was not favorable. This was by no means a randomized, double blinded prospective study, but among three of us, we did a bunch of them.
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I really respect your approach.
independent tracking of your outcomes, and stopping the treatments when you found out the outcomes were not good.
yes, more studies needed across the board. the injectate does not come from mckesson in a pre-determined vial. there are many factors that play into it, including that. even if the peripheral work is not part of your practice now, it does not mean it couldn't be if you marketed for it, or told your referrals that you were going to do peripheral msk work. that said, there is more to msk work than point and shoot as well. wish you the best of luck.
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New full page ad in Atlanta. Screams legit.
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for some reason, on going to their website ( Stem Cell Clinic Renew - Fayettevile, Georgia Regenerative Tharapy ), I was reminded of the (probably fictionalized) story of Elizabeth Bathory bathing in the blood of virgins...
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From what I can tell, she didn't do a residency at all?
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Whoever that is doing beach yoga has good thigh gap.
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Where did she train?
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Down the road from me, I've got an acupuncturist injecting fake stem cells and stirring the chi...Mu-shoo to the max.
A New Way Clinic | About
A New Way Clinic is a functional medicine practice in Southwest Portland, combining Chinese medicine, acupuncture, and other clinically-proven methods.
www.anewway.clinic
#staywoke
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Down the road from me, I've got an acupuncturist injecting fake stem cells and stirring the chi...Mu-shoo to the max.
A New Way Clinic | About
A New Way Clinic is a functional medicine practice in Southwest Portland, combining Chinese medicine, acupuncture, and other clinically-proven methods.
#staywoke
This clinic brought to you by "Tea"...
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Medical Health University Medical Center in Savannah Ga.
General Practitioner.
ie. did not complete full residency program (they apparently offer FP, IM, General Surgery, Radiology, Ob/Gyn and Pediatrics at that university).
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I did internship there. Great IM program.
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Shameful. Feel sorry for anyone who falls for this. Looked at her website, no training whatsoever, self promoter to the max. Blatant false marketing, if not outright lies. Someone should look into bull**** like this.
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this weekend, got a facebook "ad", where a service guarantees that they will send you 50-100 "stem cell patients" a month for signing up...
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It's a scam to take advantage of doctors. Most of them are predatory chiropractic management companies and several have been sued or shutdown...buyer beware...
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Don't forget to loop in orthopedic surgeons too. I've developed a good working relationship with surgeons who know that I take an evidence-based approach to orthobiologics.
PLoS One. 2019 Jul 29;14(7):e0220392. doi: 10.1371/journal.pone.0220392. eCollection 2019.
Clinical efficacy and safety of platelet-rich plasma in arthroscopic full-thickness rotator cuff repair: A meta-analysis.
Wang C1,2, Xu M1, Guo W1, Wang Y3, Zhao S2, Zhong L1.
Author information
Abstract
BACKGROUND:
Arthroscopic repair of rotator cuff tears, although commonly performed, carries the risk of retears. Therefore, bioremediation techniques such as platelet-rich plasma injections have been used as adjuvant therapies. The clinical efficacy of platelet-rich plasma in the arthroscopic repair of full-thickness rotator cuff injury is controversial. We performed a meta-analysis to evaluate the clinical effectiveness and safety of platelet-rich plasma and provide evidence-based medical recommendations for selecting the proper clinical treatment plan for full-thickness rotator cuff injuries.
METHODS:
A search for the terms "platelet-rich plasma" and "rotator cuff" was performed in the PubMed, EMBASE, and Cochrane Library databases using a computer. After conducting quality evaluations and data extraction, RevMan 5.3 software was used to combine the effect sizes, and the GRADEpro Guideline Development Tool was used to rate the level of evidence from aspects of functional score, pain score and retear rate.
RESULTS:
Eight randomized controlled trials involving 566 patients were included. The long-term retear rate(RR = 0.96, 95% CI [0.52, 1.78], P = .89), Constant score(RR = 0.96, 95% CI [0.52, 1.78], P = .89), and Visual Analog Scale score for pain (SMD = -0.28, 95% CI [-0.60, 0.04], P = .08), as well as both the long-term and short-term Disabilities of the Arm, Shoulder, and Hand scores(SMD = -0.13, 95% CI [-0.44, 0.18], P = .41;SMD = -0.02, 95% CI [-0.40, 0.36], P = .93), were not significantly different between the platelet-rich plasma and control groups. However, the short-term retear rate(RR = 0.29, 95% CI [0.13, 0.65], P = .003) and Visual Analog Scale score (SMD = -0.41, 95% CI [-0.62, -0.19], P = .0002) were significantly lower, while the short-term Constant score(SMD = 0.37, 95% CI [0.19, 0.55], P < .0001) and short-term and long-term University of California at Los Angeles activity scores (SMD = 0.38, 95% CI [0.16, 0.60], P = .0008;SMD = 0.85, 95% CI [0.48, 1.22], P < .00001) were significantly higher, in the platelet-rich plasma group than in the control group.
CONCLUSION:
Platelet-rich plasma injection can effectively improve the short-term outcomes following arthroscopic repair of full-thickness rotator cuff tears, thus reducing the rate of retears, alleviating pain, and improving patients' shoulder function. Specifically, the clinical outcomes are better with the use of platelet-rich plasma in single-row fixation than in other fixation techniques. Therefore, platelet-rich plasmainjection can be recommended as an adjuvant therapy in single-row repair for improved short-term results.
PMID: 31356630 DOI: 10.1371/journal.pone.0220392
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re RTC repair, i thought double row was becoming the standard but I'm not a orthopedic surgeon.
reduced graft failure has been found for ACL repair. Hopkins put out a lot of marketing videos based on their "better than other places" ACL repair success due to adding blood (PRP) to their grafts.
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There are discussions between patient advocates and the Feds...
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I think this whole thing could be largely fixed with the FDA stating that injecting biologics falls within the practice of medicine, not chiropractic.
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Functional Outcomes Following Microfragmented Adipose Tissue Versus Bone Marrow Aspirate Concentrate Injections for Symptomatic Knee Osteoarthritis
Kenneth Mautner Robert Bowers Kirk Easley Zachary Fausel Ryan Robinson
First published: 21 July 2019 Error - Cookies Turned Off
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Abstract
This study aimed to determine whether autologous orthobiologic tissue source affects pain and functional outcomes in patients with symptomatic knee osteoarthritis (OA) who received microfragmented adipose tissue (MFAT) or bone marrow aspirate concentrate (BMAC) injection. We retrospectively reviewed prospectively collected data from patients who received BMAC or MFAT injection for symptomatic knee OA. Patients completed baseline and follow‐up surveys. Each survey included the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire, Emory Quality of Life (EQOL) questionnaire, and Visual Analog Scale (VAS) for pain. The follow‐up responses were compared with baseline for all patients and between BMAC and MFAT groups. A total of 110 patients met inclusion criteria, with 76 patients (BMAC 41, MFAT 35) and 106 knees (BMAC 58, MFAT 48) having appropriate follow‐up data. The BMAC group included 17 females and 24 males, with a mean age of 59 ± 11. The MFAT group included 23 females and 12 males, with a mean age of 63 ± 11. Minimum follow‐up time was 0.5 years. Mean follow‐up time was 1.80 ± 0.88 years for BMAC and 1.09 ± 0.49 years for MFAT. Both groups had significant improvement in EQOL, VAS, and all KOOS parameters preprocedure versus postprocedure (p < .001). There was not a significant difference when comparing postprocedure scores between groups (p = .09, .38, .63, .94, .17, .15, .70, respectively). These data demonstrate significant improvement in pain and function with both MFAT and BMAC injections in patients with symptomatic knee OA without a significant difference in improvement when comparing the two autologous tissue sources.
Stem Cells Translational Medicine 2019
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Thanks.
However...
1. Retrospective.
2. No control group
3. Group makeup is not the same.... at least with respect to gender
So... GIGO.
However...
1. Retrospective.
2. No control group
3. Group makeup is not the same.... at least with respect to gender
So... GIGO.
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Croat Med J. 2019 Jun 13;60(3):227-236.
Early results of intra-articular micro-fragmented lipoaspirate treatment in patients with late stages knee osteoarthritis: a prospective study.
Hudetz D1, Borić I, Rod E, Jeleč Ž, Kunovac B, Polašek O, Vrdoljak T, Plečko M, Skelin A, Polančec D, Zenić L, Primorac D.
Author information
Abstract
AIM:
To analyze clinical and functional effects of intra-articular injection of autologous micro-fragmented lipoaspirate (MLA) in patients with late stage knee osteoarthritis (KOA). Secondary aims included classifying cell types contributing to the treatment effect, performing detailed MRI-based classification of KOA, and elucidating the predictors for functional outcomes.
METHODS:
This prospective, non-randomized study was conducted from June 2016 to February 2018 and enrolled 20 patients with late stage symptomatic KOA (Kellgren Lawrence grade III, n=4; and IV, n=16) who received an intra-articular injection of autologous MLA in the index knee joint. At baseline radiological KOA grade and MRI were assessed in order to classify the morphology of KOA changes. Stromal vascular fraction cells obtained from MLA samples were stained with antibodies specific for cell surface markers. Patients were evaluated at baseline and 12-months after treatment with visual analog scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Knee Injury and Osteoarthritis Outcome Score (KOOS).
RESULTS:
Three patients (15%) received a total knee replacement and were not followed up completely. Seventeen patients (85%) showed a substantial pattern of KOOS and WOMAC improvement, significant in all accounts. KOOS score improved from 46 to 176% when compared with baseline, WOMAC decreased from 40 to 45%, while VAS rating decreased from 54% to 82% (all P values were <0.001). MLA contained endothelial progenitor cells, pericytes, and supra-adventitial adipose stromal cells as most abundant cell phenotypes.
CONCLUSION:
This study is among the first to show a positive effect of MLA on patients with late stages KOA.
PMID: 31187950 PMCID: PMC6563172
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Do you guys have an opinion on methods/systems? I've been using Arthrex ACP and Angel systems with good results. I know people who use other systems as well as those who have manual processing. For those of you who do manual processing, do you find the difference valuable? Also, do you use the Lipoaspirate (LipoGems, etc) or Bone Marrow Aspirate for the cell harvest? For those of you who have used both, what do you prefer?
I'm considering branching out on my own with a Regenerative Medicine only company and am curious what the best system out there is. Obviously it's easiest with a simple centrifuge system, but I like the flexibility of products with manual processing. Thoughts?
And for those of you who use Regenexx, what do you think? My understanding is that Regenexx requires a 50K per year fee to use their systems as well as a non-compete with manual processing for 2 years after if you stop using them. Is this true? Do they do marketing for you and if so, is this a good value? I like how they measure everything and give good data, but I'm not sure if it's worth an additional 50K+ outlay just for the affiliation. Any advice here would be appreciated.
I'm considering branching out on my own with a Regenerative Medicine only company and am curious what the best system out there is. Obviously it's easiest with a simple centrifuge system, but I like the flexibility of products with manual processing. Thoughts?
And for those of you who use Regenexx, what do you think? My understanding is that Regenexx requires a 50K per year fee to use their systems as well as a non-compete with manual processing for 2 years after if you stop using them. Is this true? Do they do marketing for you and if so, is this a good value? I like how they measure everything and give good data, but I'm not sure if it's worth an additional 50K+ outlay just for the affiliation. Any advice here would be appreciated.
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SAGE Journals: Your gateway to world-class research journals
Subscription and open access journals from SAGE Publishing, the world's leading independent academic publisher.
Prospective Randomized Trial Of Biologic Augmentation With Mesenchymal Stem Cells In Patients undergoing Arthroscopic Rotator Cuff Repair
Show all authors
Brian J. Cole, MD, MBA, Nikhil N. Verma, MD, Adam Blair Yanke, MD, PhD, ...
First Published July 29, 2019 Abstract
https://doi.org/10.1177/2325967119S00275
Abstract
Objectives:
To compare the clinical outcome of arthroscopic rotator cuff repair with and without augmentation with MSCs and to identify the incidence of persistent structural defects in the tendon following surgery
Methods:
Patients aged 18-70 undergoing repair of a full-thickness supraspinatus tear or partial thickness converted to full thickness tear determined by MRI were identified and prospectively enrolled. Exclusion criteria included involvement of the subscapularis tendon, revision surgery or irreparable tear. In the injection group, 60 cc of bone marrow aspirate was drawn from the iliac crest and processed to bone marrow aspirate concentrate (BMAC) using the Arthrex Angel System (Arthrex, Naples, FL). After completion of the rotator cuff repair, half of the BMAC was injected into the tendon at the junction of the bone and tendon while the other half was injected at the site of the footprint. The control group received a small 0.5 cm incision on the hip to maintain blinding. All patients underwent a shoulder exam pre-operatively as well as at 3 months, 6 months, 1 year and 2 years post-operatively. All patients completed the Standardized Shoulder Test (SST), ASES, Constant, SANE, and VR/SF-12 questionnaires preoperatively as well as 3 months, 6 months, 12 months, 18 months and 24 months postoperatively. Baseline questionnaire scores were subtracted from scores at each timepoint to find the improvement and unpaired T-tests were performed between the two groups. Additionally, all patients underwent an MRI at 12 months postoperatively to evaluate the rotator cuff. MRIs were read by a board-certified orthopaedic surgeon and graded using the Sugaya classification system.
Results:
34 patients were randomized to the control group and 28 were randomized to the receive the injection. Average BMA MSC concentration (#/uL) was 2.63 compared to 14.95 for the BMAC MSC concentration. As a result, the BMAC was on average 5.68 times as concentrated with respect to MSC per ul when compared to the BMA. Patients received an average BMAC volume of 2.7 mL, equating to 50410.79 +/- 25375.45 mesenchymal stem cells. There were no differences across improvement in patient reported outcomes from baseline between the control group and the group randomized to receive the injection, except for the Standardized Shoulder Test at 6 months. The mean SST score at 12 months was 87.50 in the BMAC group compared with 85.32 in the control (p=0.18). The mean ASES score at 12 months was 87.38 in the BMAC group and 89.96 in the control group (0.67). Mean Sugaya score for the control group was 3.25±1.12 (range 2-5). Mean Sugaya score for the injection group was 2.60±0.91 (range 2-5). Sugaya scores showed statistical significance with Chi-squared test at 1 year postoperative MRI (p=0.0012), and approached statistical significance with independent t test (p=0.067).
Conclusion:
MSCs injected into the shoulder at the time of rotator cuff repair show improved tendon quality on post-operative MRI at 1-year post-op, based on the Sugaya scoring system, with the difference in mean Sugaya score approaching significance. Further investigation is needed into this new and evolving treatment; however, it shows promise for improving the rate of rotator cuff repair healing and overall functional outcome.
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Review of MSCs in shoulder surgery as a primer:
www.ncbi.nlm.nih.gov
GIGO meta-analysis
www.ncbi.nlm.nih.gov
The Holy Grail of Orthopedic Surgery: Mesenchymal Stem Cells—Their Current Uses and Potential Applications
Only select tissues and organs are able to spontaneously regenerate after disease or trauma, and this regenerative capacity diminishes over time. Human stem cell research explores therapeutic regenerative approaches to treat various conditions. Mesenchymal ...
www.ncbi.nlm.nih.gov
GIGO meta-analysis
Stem Cells in Rotator Cuff Injuries and Reconstructions: A Systematic Review and Meta-Analysis - PubMed
This meta-analysis confirms that stem cells improved the rehabilitation of rotator cuff disorders. However, larger-scale studies are needed to further support these findings.
www.ncbi.nlm.nih.gov
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I love the take home message - "it shows promise...".
yet the SST, ASES scores were not clinically significant.
in addition, some studies show that there is no significant correlation between Sugaya scores and clinical outcomes.
yet the SST, ASES scores were not clinically significant.
in addition, some studies show that there is no significant correlation between Sugaya scores and clinical outcomes.
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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
Prospective Randomized Trial Of Biologic Augmentation With Mesenchymal Stem Cells In Patients undergoing Arthroscopic Rotator Cuff Repair
Show all authors
Brian J. Cole, MD, MBA, Nikhil N. Verma, MD, Adam Blair Yanke, MD, PhD, ...
First Published July 29, 2019 Abstract
https://doi.org/10.1177/2325967119S00275
Abstract
Objectives:
To compare the clinical outcome of arthroscopic rotator cuff repair with and without augmentation with MSCs and to identify the incidence of persistent structural defects in the tendon following surgery
Methods:
Patients aged 18-70 undergoing repair of a full-thickness supraspinatus tear or partial thickness converted to full thickness tear determined by MRI were identified and prospectively enrolled. Exclusion criteria included involvement of the subscapularis tendon, revision surgery or irreparable tear. In the injection group, 60 cc of bone marrow aspirate was drawn from the iliac crest and processed to bone marrow aspirate concentrate (BMAC) using the Arthrex Angel System (Arthrex, Naples, FL). After completion of the rotator cuff repair, half of the BMAC was injected into the tendon at the junction of the bone and tendon while the other half was injected at the site of the footprint. The control group received a small 0.5 cm incision on the hip to maintain blinding. All patients underwent a shoulder exam pre-operatively as well as at 3 months, 6 months, 1 year and 2 years post-operatively. All patients completed the Standardized Shoulder Test (SST), ASES, Constant, SANE, and VR/SF-12 questionnaires preoperatively as well as 3 months, 6 months, 12 months, 18 months and 24 months postoperatively. Baseline questionnaire scores were subtracted from scores at each timepoint to find the improvement and unpaired T-tests were performed between the two groups. Additionally, all patients underwent an MRI at 12 months postoperatively to evaluate the rotator cuff. MRIs were read by a board-certified orthopaedic surgeon and graded using the Sugaya classification system.
Results:
34 patients were randomized to the control group and 28 were randomized to the receive the injection. Average BMA MSC concentration (#/uL) was 2.63 compared to 14.95 for the BMAC MSC concentration. As a result, the BMAC was on average 5.68 times as concentrated with respect to MSC per ul when compared to the BMA. Patients received an average BMAC volume of 2.7 mL, equating to 50410.79 +/- 25375.45 mesenchymal stem cells. There were no differences across improvement in patient reported outcomes from baseline between the control group and the group randomized to receive the injection, except for the Standardized Shoulder Test at 6 months. The mean SST score at 12 months was 87.50 in the BMAC group compared with 85.32 in the control (p=0.18). The mean ASES score at 12 months was 87.38 in the BMAC group and 89.96 in the control group (0.67). Mean Sugaya score for the control group was 3.25±1.12 (range 2-5). Mean Sugaya score for the injection group was 2.60±0.91 (range 2-5). Sugaya scores showed statistical significance with Chi-squared test at 1 year postoperative MRI (p=0.0012), and approached statistical significance with independent t test (p=0.067).
Conclusion:
MSCs injected into the shoulder at the time of rotator cuff repair show improved tendon quality on post-operative MRI at 1-year post-op, based on the Sugaya scoring system, with the difference in mean Sugaya score approaching significance. Further investigation is needed into this new and evolving treatment; however, it shows promise for improving the rate of rotator cuff repair healing and overall functional outcome.
Motivated reasoning - Wikipedia
I’m sorry, I really would love to believe in regenerative medicine. I could certainly use the cash pay influx in my practice. I do think there is some good evidence for PRP for certain conditions, but if this is the evidence that’s being used to justify stem cells then “further research needed” is an understatement.
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Brain and Nervous System
Find brain and nervous system information and latest health news.
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Brain and Nervous System
Find brain and nervous system information and latest health news.www.webmd.com
That article is not the least bit biased...
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Did not read it. Posted it to vex you. From NY
uh oh looks like you will be called doclobelsteve for not reading in 3....2.....1....
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Malanga = PRP and MSC salesman. Down plays risks, upsells benefits. Badmouths alternative treatments including steroid injections with misleading or false statements.
SIS. 2019
SIS. 2019
