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Please select the response that BEST describes your opinion.
Provable: certain practices within regenerative medicine are already proven to work.
Only in your mind.
Please post the studies that document your assertion.Provable: certain practices within regenerative medicine are already proven to work.
expansion is not easy or pratical (or legal) for majority of MD's. Studies need to differentiate.
Since this is a STUDENT doctor forum, I will explain to the students why I take all of those studies posted by @GH253 with a grain of salt. Every last one of them is a "preliminary" or "proof of concept" study. All that suggests is that it MIGHT work. I for one, will never change my practice for a study (or 10 studies for that matter) with a n=18.
We need LARGE multicenter studies to prove effectiveness and long term improvement vs. controls. This reminds me so much of IDET when it was first introduced. People were jumping on that bandwagon too. But when the 5 and 7 yr results were published? No more IDET.
I hope that these large multicenter studies are indeed published someday. I hope that this is the "miracle" cure for osteoarthritis. But I ain't holding my breath.
But you can make so much money...
@sloh that is the problem. We don't know. My gut instinct is that the second patient would be a better candidate, but that is exactly why we need big trials with lots of patients with different demographics.
So until that indeterminate "someday," which is at least decades away, you want members of the healthy, responsible group to suffer and die while waiting for the results of your big trials that can't even get under way for financial reasons?
I'm sorry...but there is absolutely no reason why a multi-center study couldn't be performed. All it would take is coordination. We have cars that can drive themselves and we can't get a group of Physiatrists and Sports Medicine physicians to collaborate a study that would revolutionize medicine? I have two words for that...lazy and embarrassing. Many physicians don't care about efficacy...and many may even be afraid of efficacy studies. They would rather continue to sell their snake oil to desperate patients that are more than willing to buy it up.
Quit the BS. This isn't about finances nor government regulation...this is about physicians would care more about fattening their wallets than helping patients.
But it is very much about regulation and finances. The FDA has regulated cultured stem cells as drugs since 2012. You should be able to figure out what that means: an average time of 15 years and prices tag of $1 billion+ to get regulatory approval for a novel product. And it will likely have to be approved discretely for every individual joint in which it is to be used. Nobody is going to be able to come up with those kinds of resources unless it's for a patentable, off-the-shelf product whose sales can recoup the investment, which in turn means the product has to be inexpensive enough to produce that it can gain widespread insurance coverage. If it is cost prohibitive it will simply never happen. Now this desperately needed revolutionary technology is dead in the water thanks to the view that anyone's will other than the patient's should prevail when it comes to his own medical decisions.
Scientists need to be unbiased. This technology is currently unproven. Patient's and physician's medical decision-making needs to be informed by all relevant information. The lack of data makes prp, amniotic tissue, and stem cells snake oil at present. Promising snake oil, but snake oil all the same.Now this desperately needed revolutionary technology is dead in the water thanks to the view that anyone's will other than the patient's should prevail when it comes to his own medical decisions.
best way to win an argument.
Post a meme.
I fear for our society
Several issues: That isn't a picture of the Nobel prize winner. He isn't a physician. And he isn't American. So while he is undoubtedly smarter than I am, he isn't in a position to offer an informed opinion on US FDA policy.
“When I was commissioner of the Food and Drug Administration (FDA) from 2005 to 2009, I saw firsthand how regenerative medicine offered a cure for kidney and heart failure and other chronic conditions like diabetes. Researchers used stem cells to grow cells and tissues to replace failing organs, eliminating the need for expensive supportive treatments like dialysis and organ transplants…
For example, in August 2010, the FDA filed suit against a company called Regenerative Sciences. Three years earlier, the company had begun marketing a process it called Regenexx to repair damaged joints by injecting them with a patient’s own stem cells. The FDA alleged that the cells the firm used had been manipulated to the point that they should be regulated as drugs. A resulting court injunction halting use of the technique has cast a pall over the future of regenerative medicine.“
True. But you know what's a much worse appeal to authority? The idea that FDA bureaucrats are the only ones who know how to determine whether a technology is safe and effective.
I just got back from the AAPMR meeting. Went to some lectures on regenerative medicine for DJD and DDD. Not one person presented any credible research that shows significant effectiveness. Only preliminary studies that show that further study is needed. But in the technical exhibits there were no less than 10 vendors trying to sell us ways to integrate this unproven technology into our practices. Money is driving this instead of patient care
I already provided you with a list representing only a fraction of the credible studies out there showing objective radiological and histological evidence of cartilage regeneration. The idea that placebo-controlled clinical trials are the only acceptable form of evidence comes from the FDA and makes no sense from a medical or safety standpoint.
http://jama.jamanetwork.com/article.aspx?articleid=185200You don't need FDA approval for a clinical trial. You need a well designed study with patient consent. Thus far...other than for tennis elbow...physicians haven't done that.
http://jama.jamanetwork.com/article.aspx?articleid=185200
Nah, this is a pretty well designed study with 54 people for achilles tendinopathy.
and there was no benefit to saline injection.
Of course ALL patients received Eccentric exercise
Well, when it emerges from the pipeline, do let us know. For now, it is still all smoke and mirrors, all hat, no cattle.There is a ton of research in the pipeline. And to analogize regenerative medicine with IDET is not apples to apples. Orthos have been doing regenerative techniques for years.....just not concentrated enough. I admire the passion on both sides.
I have not once mentioned IDET. . However, I believe Roukie's point is, IDET was touted and over utilized based on preliminary data. Once definitive RCTs were completed? No one who puts their patients' well being first continues to do the procedure.You yourself admit adequate research has been done for epicondylitis.....how is it so much of a stretch to extend it to other body parts? Again....u keep harping IDET.....but it is not even close to being a similar comparison. Ive performed the procedure on myself and hundreds of patients.....the results are there.
I've seen horrific and even fatal outcomes of stem cell therapy in my prior career. There is a reason we regulate stem cells like drugs- because we need expansive studies to prove they are safe, and if they are not safe, we need these studies to point us in the direction as to why so that we can improve things in the future. We also need them so that we can provide full disclosure to our patients that will allow them to provide proper consent with the full knowledge of risks and benefits of the treatment being offered, not some doctor's n=1, anecdotal opinion that is likely colored by confirmation bias.It is very much about regulation and finances. The FDA has regulated cultured stem cells as drugs since 2012. You should be able to figure out what that means: an average time of 15 years and prices tag of $1 billion+ to get regulatory approval for a novel product. And it will likely have to be approved discretely for every individual joint in which it is to be used. Nobody is going to be able to come up with those kinds of resources unless it's for a patentable, off-the-shelf product whose sales can recoup the investment, which in turn means the product has to be inexpensive enough to produce that it can gain widespread insurance coverage. If it is cost prohibitive it will simply never happen. Now this desperately needed revolutionary technology is stillborn thanks to the view that anyone's will other than the patient's should prevail when it comes to his own medical decisions.
I have not once mentioned IDET. . However, I believe Roukie's point is, IDET was touted and over utilized based on preliminary data. Once definitive RCTs were completed? No one who puts their patients' well being first continues to do the procedure.
That u are willing to subject "hundreds" of your patients to unproven therapy says all I need to know.
http://www.ncbi.nlm.nih.gov/pubmed/25881762
http://www.ncbi.nlm.nih.gov/pubmed/24782334
http://www.ncbi.nlm.nih.gov/pubmed/24563387
http://www.ncbi.nlm.nih.gov/pubmed/24363098
http://www.ncbi.nlm.nih.gov/pubmed/24169302
I read the first link......it was pretty vague and ambiguous.....but it didnt support your case. Your selfrighteous comment about my practice is "all u need to know" is noted. Let's leave it at this.....u keep injecting corticosteroids like water and prescribing statins and other drugs you have been lead to believe help.....ill keep doing what im doing which u keep incorrectly and disingenuously saying is unproven, which is actually healing patients. Deal? Bye bye.
But yeah, I'd love it if we could just draw my blood and grow me a knee replacement, but it's going to take more than that.
I'm the one who brought up IDET. And it was just used to elucidate how we in medicine tend to jump on the latest new treatment when preliminary studies are published. Then, when the long term data are published, these "Miracle cures" just fade away into obscurity. I'm old enough to have seen Chymopapain, IDET and last annuloplasty all come and go for the treatment of discogenic pain. Now Centeno is injecting stem cells into the disc. Maybe it will work. Maybe not.
But we as a profession, should not be using ANY novel treatment until large, multicenter RCTs are done. With long term follow up. That is piece that is missing with regenerative medicine.
But we as a profession, should not be using ANY novel treatment until large, multicenter RCTs are done. With long term follow up. That is piece that is missing with regenerative medicine.
http://www.ncbi.nlm.nih.gov/pubmed/25952818http://www.ncbi.nlm.nih.gov/pubmed/26432430
Arthroscopy. 2015 Sep 29. pii: S0749-8063(15)00659-3. doi: 10.1016/j.arthro.2015.08.005. [Epub ahead of print]
Efficacy of Intra-articular Platelet-Rich Plasma Injections in Knee Osteoarthritis: A Systematic Review.
CONCLUSIONS:
In patients with symptomatic knee OA, PRP injection results in significant clinical improvements up to 12 months postinjection. Clinical outcomes and WOMAC scores are significantly better after PRP versus HA at 3 to 12 months postinjection. There is limited evidence for comparing leukocyte-rich versus leukocyte-poor PRP or PRP versus steroids in this study.
LEVEL OF EVIDENCE:
Level I, systematic review of Level I studies.