Regenerative Medicine

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Please cite the literature that states that mesenchymal stem cells develops or produces cancer?

There are multiple studies that mention the risk of malignancy associated with PRP. PRP is essentially a bag of growth factors. There are not any quality safety for use studies and therein lies the problem. We don't know if PRP causes cancer because it hasn't been thoroughly studied. Here are a few studies mentioning the theoretical risk...and there are many others.

-Wang G, Avila G. Platelet Rich Plasma: Myth or Reality? Eur J Dent. 2007 Oct; 1(4): 192–194.
-Landesberg R, Moses M, Karpatkin M. Risks of using platelet rich plasma gel. J Oral Maxillofac Surg. 1998;56:1116–1117.
-Choi J, Minn KW, Chang H. The Efficacy and Safety of Platelet-Rich Plasma and Adipose-Derived Stem Cells: An Update. Arch Plast Surg. 2012 Nov; 39(6): 585–592.


The big theoretical risk for MSC is teratoma considering that you are injecting pluripotent stem cells with or without growth factors within a confined space. Heck...the father of pluripotent stem cells (Leroy Stevens) discovered them through research on teratomas in the '50s. What is the percentage of cells being incorporated into the focus of damage? ...We don't know. What is happening to the cells that aren't being incorporated into the focus of damage? Again...we don't know. Signaling pathways of MSC's are complex and incompletely understood. Multiple sources have expressed concern about MSCs and teratoma and/or cancer signaling. Here are a few...but there are many others.

-Xin W, Yang Z, Han Z, Fang-fang Q, Shao L, Shi Y. Mesenchymal stem cells: a new trend for cell therapy. Acta Pharmacologica Sinica (2013) 34: 747–754
-Cunningham J, Ulbright T, Pera M, Looijenga L. Lessons from human teratomas to guide development of safe stem cell therapies. Nature Biotechnology. 2012. 30: 849-857
-Torsvik A, Bjerkvig R. Mesenchymal stem cell signaling in cancer progression. Cancer Treatment Reviews. 2013 Apr; 39(2): 180-188

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Because that is not how medicine works, or worse yet how silly treatments become the "standard of care". There was a time not too long ago when people had multilevel fusions for "Black disk disease" (otherwise known as degenerative disk disease)

"That is not how medicine works" isn't a satisfactory answer. The reason the country is embroiled in bitter controversy over the healthcare system is because the current one doesn't work. Just because something is the standard of care doesn't mean it actually qualifies as good care; if regenerative medicine has potential to reverse devastating ailments that the current standard of care can only palliate, then it's worse than silly to remain satisfied with the latter.
 
You left out Jay Smith, MD. He's still kind of a "big name" for the field too...

that dude's totally fringe! Mayo doesn't do real research (randomized double blinded placebo controlled multicenter meta analysis with p<.0000000001), so what the hell does he or the rest of Mayo clinic know about anything! quacks, all of them, heretics and witches. the world is flat!
Atticus Finch is a saint!
oh yeah
10410370_969242913133649_925806146880160851_n.jpg
 
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"That is not how medicine works" isn't a satisfactory answer. The reason the country is embroiled in bitter controversy over the healthcare system is because the current one doesn't work. Just because something is the standard of care doesn't mean it actually qualifies as good care; if regenerative medicine has potential to reverse devastating ailments that the current standard of care can only palliate, then it's worse than silly to remain satisfied with the latter.

You are proving the point. Many things become the "standard of care" purely because a bunch of people "THINK" it works. Like the whole concept of discography and multilevel fusion for low back pain. I challenge you to find any good literature that really supports them. That is why we need to be doing real good quality research before we start doing potentially dangerous interventions.

I for one am not satisfied to maintain the status quo. But I also will not jump on the PRP bandwagon until we start showing some efficacy and long term safety.

I've already seen chymopapain, IDET, laser disc, and the Charite disc replacement come and go for discogenic pain. All of those procedures were created by doctors who had the best of intentions. They wanted to fix people.
 
"That is not how medicine works" ... if regenerative medicine has potential ...
Actually, "First do no harm" is how medicine works.

If you want to experiment on patients, do it under the supervision of an IRB. Doing it for cash speaks to yor motivation; if you believe you "potentially" doing what's best for the patient, you should have to prove it is both safe and efficacious before getting paid. Otherwise, you might just as well do a sham injection, since the best you can prove at present is that it's as good as a placebo.
 
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you should have to prove it is both safe and efficacious before getting paid.

Why should that be the case? Because you and the self-appointed czars at the FDA say so? I should be able to offer whatever treatment I want, for whatever price I want, and patients should be able to choose whether they want to pay it or not. Every individual should have the liberty to act on his own judgement as to what's best for himself, and nobody should have to accept the edits of bureaucrats a substitute for his freedom.
 
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Why should that be the case? Because you and the self-appointed czars at the FDA say so? I should be able to offer whatever treatment I want, for whatever price I want, and patients should be able to choose whether they want to pay it or not. Every individual should have the liberty to act on his own judgement as to what's best for himself, and nobody should have to accept the edits of bureaucrats a substitute for his freedom.
Why should you have to prove your proposed procedure is safe? Not to be redundant, but because the primary tenant in medicine is first do no harm.

Your right to freedom is not unlimited, and ends when you can potentially hurt someone else.
 
Why should that be the case? Because you and the self-appointed czars at the FDA say so? I should be able to offer whatever treatment I want, for whatever price I want, and patients should be able to choose whether they want to pay it or not. Every individual should have the liberty to act on his own judgement as to what's best for himself, and nobody should have to accept the edits of bureaucrats a substitute for his freedom.

are you an actual physician? Or are you just trolling?
 
are you an actual physician? Or are you just trolling?

Are you implying that no actual physician would oppose the existence of FDA? Au contraire, to the extent that one's attitude toward medicine revolves around the edicts of regulators, he is not a competent physician.
 
Are you implying that no actual physician would oppose the existence of FDA? Au contraire, to the extent that one's attitude toward medicine revolves around the edicts of regulators, he is not a competent physician.

no not the FDA part. THIS part:
I should be able to offer whatever treatment I want, for whatever price I want, and patients should be able to choose whether they want to pay it or not.

As a physician, you are in a position of power. It is your obligation to know that a treatment is both safe and efficacious before even offering it to a patient. In most of our patient's eyes we are the experts. If you use that power to push things that MIGHT work, you are being negligent. That is quackery. By doing so, you are equating your treatment to the equivalent of Magnet therapy, chiropractic, naturopathic "medicine", and other pseudo treatments.

I've seen you asking about anterior approach for harvesting bone marrow. This speaks to your lack of anatomy knowledge. It is your posts that make me question your qualifications and your training.
 
no not the FDA part. THIS part:
I should be able to offer whatever treatment I want, for whatever price I want, and patients should be able to choose whether they want to pay it or not.

As a physician, you are in a position of power. It is your obligation to know that a treatment is both safe and efficacious before even offering it to a patient. In most of our patient's eyes we are the experts. If you use that power to push things that MIGHT work, you are being negligent. That is quackery. By doing so, you are equating your treatment to the equivalent of Magnet therapy, chiropractic, naturopathic "medicine", and other pseudo treatments.

I've seen you asking about anterior approach for harvesting bone marrow. This speaks to your lack of anatomy knowledge. It is your posts that make me question your qualifications and your training.

I am not arguing that it is moral for a physician to push quack treatments for which there is no legitimate scientific basis. However, there is much room for disagreement as to what the standards of "safety" and "effectiveness" ought to be in a given context. Under the current political system, those terms represent arbitrary conventions established by regulators who force one standard on everyone, and I submit that this is a highly unethical and oppressive system that ultimately does great harm to patients, resulting in far greater suffering and death than it prevents as providers altogether lose the freedom to offer viable therapies that people desperately need. It sacrifices the good for the sake of the bad, the latter of which is actually a marginal element.

In reality there is never a universal standard of “safety” and “effectiveness” that applies to everyone; instead, the risks of benefits of a given therapy are highly context-dependent, and an an individual can only weigh for himself in relation to the circumstances of his life and his own values. For his own sake, the patient needs to have the freedom to act on his own judgment as to what he thinks is best for himself. But the corollary of patient freedom is provider freedom; in order for patients to have the freedom to access treatments, providers must have the freedom to offer them.

Just because a treatment may be considered experimental does not mean it’s on the same level as magnets, chiropractic, and naturopathy. Those are superstitious notions which there are no legitimate reasons to think are of any value (interestingly, the government sanctions them anyway by licensing the practitioners who offer them). In contrast, to relate the issue to the threat topic, intra-articular injection of cultured MSCs have strong early evidence stacking up in their favor, yet clinicians likely won’t be able to offer them for decades thanks to utterly outrageous regulatory burdens that are so expensive to comply with that there is no funding by investors to even get the ball rolling toward FDA approval. The result is that millions upon millions are going to suffer needlessly thanks to the prevalence of the regulatory mentality, which assumes that all therapies are equally suspect until they satisfy a small body of all-powerful bureaucrats.

Read following thread I posted in another subforum. The technology to resurface arthritic joints with laboratory-engineered articular cartilage now exists, but it's completely stillborn thanks to FDA regulations:

http://forums.studentdoctor.net/thr...-nations-leading-cause-of-disability.1148960/
 
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Bull$hit. Just because it "makes sense" doesn't mean it works.
 
Bull$hit. Just because it "makes sense" doesn't mean it works.

People smarter than you may realize that something works even when you and the bureaucrats you depend on fail to. There is no reason why your mediocrity should hold anyone else back.
 
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Prove it. Seriously, if all you've got is I'm smarter than you, or it works cause I say it works, just shut up already.

You have yet to respond to first do no harm. Apparently this is also one of those it's safe cause I say it's safe tautologies.
 
i like captain crunch
 
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I dont think the case for "unsafe" has been supported, so the do no harm only applies to the competency of the dr. If you want to claim we should do no harm, then nobody should be injecting corticosteroids or marcaine into any joint that has healthy cartilage....but it is done anyway. And that is CLEARLY harmful.
 
You have the obligation to prove that what you are doing IS safe.

If you can't demonstrate safety of the procedure you propose, you are putting your patient at unnecessary risk.

If you can't prove efficacy, you you are putting your patient at unnecessary risk without any likely hood of improvement.

So you are putting your patient at unnecessary risk , without any likely hood of improvement because it has unproven potential?

C'mon, at least admit you are doing it to get rich, and for no other justifiable reason.
 
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You cant charge much because few will pay for it. Back to topic, there are plenty of studies which showed excellent safety, including no cancer.
 
Prove it. Seriously, if all you've got is I'm smarter than you, or it works cause I say it works, just shut up already.

You have yet to respond to first do no harm. Apparently this is also one of those it's safe cause I say it's safe tautologies.

You continue to evade the crux of the issue, which is why one person's judgment should supersede anyone else's. Requiring proof means that someone has to be in a postion to impose the requirement and judge the evidence—who is that? You? The regulators? And how did those supposed "experts" get so smart, so all-knowing?

"First do no harm" is something that new doctors mumble as a meaningless ritual. It has no morally binding power and provides no guide to action. All interventions cause harm of some kind—NSAIDs and steroid injections most certainly cause it. The bureaucrats who prevent doctors from using their own judgement do far more harm to patients than the unrestricted use of experimental therapies ever could.
 
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Phentolamine. Thalidomide. DES. Dalkon Shield.

All good ideas. Till they werent.
 
You have the obligation to prove that what you are doing IS safe.

There is plenty of data indicating PRP is safe, show me the study that proves it is unsafe. If you question a specific procedure then call it out, but don't generalize that ALL PRP is unsafe. Differentiate between safety and efficacy and don't blur the lines between the two. Something can be safe and not very efficacious. Alternatively, something can be unsafe yet extremely efficacious. The two are not the same.
 
There are multiple studies that mention the risk of malignancy associated with PRP. PRP is essentially a bag of growth factors. There are not any quality safety for use studies and therein lies the problem. We don't know if PRP causes cancer because it hasn't been thoroughly studied. Here are a few studies mentioning the theoretical risk...and there are many others.

-Wang G, Avila G. Platelet Rich Plasma: Myth or Reality? Eur J Dent. 2007 Oct; 1(4): 192–194.
-Landesberg R, Moses M, Karpatkin M. Risks of using platelet rich plasma gel. J Oral Maxillofac Surg. 1998;56:1116–1117.
-Choi J, Minn KW, Chang H. The Efficacy and Safety of Platelet-Rich Plasma and Adipose-Derived Stem Cells: An Update. Arch Plast Surg. 2012 Nov; 39(6): 585–592.


The big theoretical risk for MSC is teratoma considering that you are injecting pluripotent stem cells with or without growth factors within a confined space. Heck...the father of pluripotent stem cells (Leroy Stevens) discovered them through research on teratomas in the '50s. What is the percentage of cells being incorporated into the focus of damage? ...We don't know. What is happening to the cells that aren't being incorporated into the focus of damage? Again...we don't know. Signaling pathways of MSC's are complex and incompletely understood. Multiple sources have expressed concern about MSCs and teratoma and/or cancer signaling. Here are a few...but there are many others.

-Xin W, Yang Z, Han Z, Fang-fang Q, Shao L, Shi Y. Mesenchymal stem cells: a new trend for cell therapy. Acta Pharmacologica Sinica (2013) 34: 747–754
-Cunningham J, Ulbright T, Pera M, Looijenga L. Lessons from human teratomas to guide development of safe stem cell therapies. Nature Biotechnology. 2012. 30: 849-857
-Torsvik A, Bjerkvig R. Mesenchymal stem cell signaling in cancer progression. Cancer Treatment Reviews. 2013 Apr; 39(2): 180-188
 
I don’t believe you actually care about the well-being of patients. If you did, you’d be far more concerned about the epidemic of unmet medical needs that will kill millions and ruin countless more lives than an incident that caused a few thousand birth defects in pre-Nazi Germany. Your real character is basically squalor; you have an emotional need to believe that anyone who sells anything is a charlatan, most likely because you perceive others’ success as a threat to your own prestige. You feign concern for patient safety to rationalize crushing innovators.
 
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.
 
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So rather than addressing the issue, you resort to attacking my character. Pathetic.

What do you think you're doing when you accuse people who defend regenerative medicine of fleecing patients for their own gain?
 
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whats next on the agenda GH253? Limb transplant using cadaver limbs? Or even better...full body transplant?

Who cares if it could hurt the patient...there is a theoretical chance of it working..it could save millions of lives...and it could make my wallet significantly fatter.
 
Bilateral hand transplants....ooooops already done.
 
The biggest problem that I have with regenerative medicine is that though its current use is purely academic, many doctors using it have absolutely no investment in determining a side effect profile and efficacy. It's a money grab. This in the long run is going to screw people like me who hope to use the treatments on patients after it has been determined to be safe and efficacious. That is how you help patients...by being apart of a multicenter trial with defined parameters. As of right know the doctors are guessing on the parameters of their treatments. How much to give? With what scaffold? With what growth factors? Since the preclinical and clinical trials are inconsistent at best...it's pure guesswork. Not knowing how to properly administer treatment is not real medicine.
 
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I know what you mean. I just got back from the spine intervention society conference in Las Vegas.

I spoke or heard from dozens of well regarded physicians (Leaders in the field) about their protocols for spine injections. some world leaders that have produced a lot of the literature that is widely referenced use 80mg of kenalog in their ESI, some use 40. some are saying no benefit from steroid at all and advocate for saline only. many people told me they've found the switch to dex for TFESI to greatly reduce the duration of effect, even though they continue to quote paper(s) that say they are nearly the same. a lot then told me they have made the switch back to particulates. everyone thinks that their technique is the best, and it's a country bumpkin with poor technique that paralyzes someone. one of the prominent speakers told me of a well regarded academic friend who paralyzed someone not too long ago. some have seen the literature that states no difference between 8 and 4mg of dexamethasone, but continue to use 12mg because they know best. how many of you have stopped performing ESI for stenosis since the Friedly article? it's easy to dismiss literature that doesn't agree with your dogma. everyone at SIS seemed to be guessing on the parameters of their treatments as well, and I think that is "real medicine"

"regenerative medicine" doesn't come with the same risks as some of the similar procedures widely performed for the same problems. (but they may come with others that we don't know about yet.) LA and steroids are at least in vitro thought to be chondrotoxic. the side effect profile should be pretty good and like all things, patient dependent. long term Im guessing we'll see the infection rate is much lower for PRP than corticosteroid, viscosupplementation, or anything else immunosuppressive. PRP has been demonstrated to be just as good as viscosupplementation at 6 months for knee OA, and doesn't carry the potential for reactive synovitis. PRP + tenotomy has been shown to be better than dry needling alone for lateral epicondylopathy. If the elbow pain returns after your conservative treatment, corticosteroid injection, PT, and bracing what else do you offer this patient without risking more injury from repeated steroid injections? surgery? I honestly think it's a fair treatment to have on the table given the evidence, risk, and benefits compared to the current options.

I would love for the "science fiction" to be real NOW. the 3D printed menisci they are working on in Japan made from your own stem cells, stem cells for cardiac wall injury, a cure for retinosis pigmentosa, finally something that works for degenerative discs, etc etc etc

there certainly is commercalization involved. Regenerative medicine is exciting, and where a lot of big dollars are being invested. But the money grab happens in every facet of medicine (law, business, etc) PCPs doing sigmoidoscopy? US for every knee injection? PCPs doing in office ECHO in the 2000s. Chiro's doing XR for peripheral neuropathy, A stim, E stim....

I think the increased utilization of this modality will actually invite more intense scrutiny and better quality research. hopefully by the time you or your children have knee OA pain the standard of care will no longer be kenalog and LA.
 
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Cochrane Database Syst Rev. 2013 Dec 23;12:CD010071. doi: 10.1002/14651858.CD010071.pub2.
Platelet-rich therapies for musculoskeletal soft tissue injuries.
Moraes VY, Lenza M, Tamaoki MJ, Faloppa F, Belloti JC.

Abstract
BACKGROUND:
Platelet-rich therapies are being used increasingly in the treatment of musculoskeletal soft tissue injuries such as ligament, muscle and tendon tears and tendinopathies. These therapies can be used as the principal treatment or as an augmentation procedure (application after surgical repair or reconstruction). Platelet-rich therapies are produced by centrifuging a quantity of the patient's own blood and extracting the active, platelet-rich, fraction. The platelet-rich fraction is applied to the injured tissue; for example, by injection. Platelets have the ability to produce several growth factors, so these therapies should enhance tissue healing. There is a need to assess whether this translates into clinical benefit.

OBJECTIVES:
To assess the effects (benefits and harms) of platelet-rich therapies for treating musculoskeletal soft tissue injuries.

SEARCH METHODS:
We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (25 March 2013), the Cochrane Central Register of Controlled Trials (CENTRAL 2013 Issue 2), MEDLINE (1946 to March 2013), EMBASE (1980 to 2013 Week 12) and LILACS (1982 to March 2012). We also searched trial registers (to Week 2 2013) and conference abstracts (2005 to March 2012). No language or publication restrictions were applied.

SELECTION CRITERIA:
We included randomised and quasi-randomised controlled trials that compared platelet-rich therapy with either placebo, autologous whole blood, dry needling or no platelet-rich therapy for people with acute or chronic musculoskeletal soft tissue injuries. Primary outcomes were functional status, pain and adverse effects.

DATA COLLECTION AND ANALYSIS:
Two review authors independently extracted data and assessed each study's risk of bias. Disagreement was resolved by discussion or by arbitration by a third author. We contacted trial authors for clarification of methods or missing data. Treatment effects were assessed using risk ratios for dichotomous data and mean differences (MD) or standardised mean differences (SMD) for continuous data, together with 95% confidence intervals. Where appropriate, data were pooled using the fixed-effect model for RR and MD, and the random-effects model for SMD. The quality of the evidence for each outcome was assessed using GRADE criteria.

MAIN RESULTS:
We included data from 19 small single centre trials (17 randomised and two quasi-randomised; 1088 participants) that compared platelet-rich therapy with placebo, autologous whole blood, dry needling or no platelet-rich therapy. These trials covered eight clinical conditions: rotator cuff tears (arthroscopic repair) (six trials); shoulder impingement syndrome surgery (one trial); elbow epicondylitis (three trials); anterior cruciate ligament (ACL) reconstruction (four trials), ACL reconstruction (donor graft site application) (two trials), patellar tendinopathy (one trial), Achilles tendinopathy (one trial) and acute Achilles rupture surgical repair (one trial). We also grouped trials into 'tendinopathies' where platelet-rich therapy (PRT) injections were the main treatment (five trials), and surgical augmentation procedures where PRT was applied during surgery (14 trials). Trial participants were mainly male, except in trials including rotator cuff tears, and elbow and Achilles tendinopathies.Three trials were judged as being at low risk of bias; the other 16 were at high or unclear risk of bias relating to selection, detection, attrition or selective reporting, or combinations of these. The methods of preparing platelet-rich plasma (PRP) varied and lacked standardisation and quantification of the PRP applied to the patient.We were able to pool data for our primary outcomes (function, pain, adverse events) for a maximum of 11 trials and 45% of participants. The evidence for all primary outcomes was judged as being of very low quality.Data assessing function in the short term (up to three months) were pooled from five trials that assessed PRT in three clinical conditions and used four different measures. These showed no significant difference between PRT and control (SMD 0.24; 95% confidence interval (CI) -0.07 to 0.56; P value 0.13; I² = 35%; 273 participants; positive values favour PRT). Medium-term function data (at six months) were pooled from six trials that assessed PRT in five clinical conditions and used six different measures. These also showed no difference between groups (SMD 0.06; 95% CI -0.39 to 0.51; P value 0.79; I² = 64%; 262 participants). Long-term function data (at one year) were pooled from 10 trials that assessed PRT in five clinical conditions and used six different measures. These also showed no difference between groups (SMD 0.25, 95% CI -0.07 to 0.57; P value 0.12; I² = 66%; 484 participants). Although the 95% confidence intervals indicate the possibility of a slightly poorer outcome in the PRT group up to a moderate difference in favour of PRT at short- and long-term follow-up, these do not translate into clinically relevant differences.Data pooled from four trials that assessed PRT in three clinical conditions showed a small reduction in short-term pain in favour of PRT on a 10-point scale (MD -0.95, 95% CI -1.41 to -0.48; I² = 0%; 175 participants). The clinical significance of this result is marginal.Four trials reported adverse events; another seven trials reported an absence of adverse events. There was no difference between treatment groups in the numbers of participants with adverse effects (7/241 versus 5/245; RR 1.31, 95% CI 0.48 to 3.59; I² = 0%; 486 participants).In terms of individual conditions, we pooled heterogeneous data for long-term function from six trials of PRT application during rotator cuff tear surgery. This showed no statistically or clinically significant differences between the two groups (324 participants). Pooled data for short-term function for threeelbow epicondylitis trials (179 participants) showed a statistically significant difference in favour of PRT, but the clinical significance of this finding is uncertain.The available evidence is insufficient to indicate whether the effects of PRT will differ importantly in individual clinical conditions.

AUTHORS' CONCLUSIONS:
Overall, and for the individual clinical conditions, there is currently insufficient evidence to support the use of PRT for treating musculoskeletal soft tissue injuries. Researchers contemplating RCTs should consider the coverage of currently ongoing trials when assessing the need for future RCTs on specific conditions. There is need for standardisation of PRP preparation methods.
 
http://www.regenexx.com/2015/08/does-your-stem-cell-doctor-know-what-hes-doing/

"doctors who don’t have the base training to do this type of work, who are poorly trained

I can break these stem cell doctors down into a few different categories:

1. “I have no clue how to use guidance”-These physicians include many orthopedic surgeons and family doctors. For example, they know that injecting stem cells into the knee joint accurately is important, but they refuse to use imaging guidance to ensure they’re in the joint.

6. “I only kinda know where I’m injecting…”-These doctors use guidance (unlike the category described as #1 above), but they only use it at the most basic level of competency. So for example, if your ACL ligament in the knee needs stem cells, they would have no idea how to get stem cells to that specific spot, simply how to generally get them inside the knee joint which won’t help your ACL much."
 
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Wow. Only docs that use their proprietary magic juice know what they are doing... Some folks like autologous but that wont pay
 
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bit of a side tangent question, but are there any fellowships in pmr that have a focus on regenerative medicine? the closest thing i could find was a stem cell fellowship for internal med
 
bit of a side tangent question, but are there any fellowships in pmr that have a focus on regenerative medicine? the closest thing i could find was a stem cell fellowship for internal med

Not yet.

http://www.ncbi.nlm.nih.gov/pubmed/23477401

Regen Med. 2013 Mar;8(2):223-5. doi: 10.2217/rme.13.1.
Call for fellowship programs in stem cell-based regenerative and cellular medicine: new stem cell training is essential for physicians.
Knoepfler PS1.
Author information

Abstract
Stem cell-based regenerative and cellular medicine is an exciting, emerging area of medical practice. While bone marrow transplantation, a stem cell-based therapy, has been a part of medicine for decades, in recent years newer and more diverse forms of stem cell-based therapies are being used to treat a rapidly growing population of patients in the USA as well as worldwide. Nonetheless, to this author's knowledge, there is currently not a single academic medical fellowship training program in the USA that specifically prepares physicians for treating patients with stem cell-based therapies other than bone marrow or hematopoietic stem cell transplantation. An increasing number of physicians untrained in stem cell-based regenerative and cellular medicine are nonetheless transplanting stem cells into hundreds if not thousands of patients for a striking diversity of conditions. Furthermore, as stem cell technology advances, a growing number of physicians with academic affiliations may look to legitimately practice regenerative and cellular medicine. What little training that physicians can currently obtain must be found on an ad hoc basis. This article should act as a call for the development of formal academic medical fellowship programs to train physicians in the practice of cellular and regenerative medicine. The USA is used here as an example of a medical sphere in which it can be argued that such training would be helpful, however such programs would be quite helpful globally.

Stem Cells Transl Med. 2015 Feb;4(2):118-22. doi: 10.5966/sctm.2014-0144. Epub 2014 Dec 29.
Clinical research skills development program in cell-based regenerative medicine.
Schulman IH1, Suncion V2, Karantalis V2, Balkan W2, Hare JM2; Cardiovascular Cell Therapy Research Network.
Author information

Abstract
SummaryCell-based therapy aimed at restoring organ function is one of the most exciting and promising areas of medical research. However, a novel intervention like cell-based therapy requires physician education and training. An increasing number of physicians untrained in regenerative medicine are using cell-based therapy to treat patients for a wide variety of chronic illnesses. The current lack of training for physicians in this area combined with the sharply increasing practice of regenerative medicine is concerning for a number of reasons, namely potential harm to patients and avoidable conflicts between governmental regulatory agencies and physicians. Academic medical fellowship training programs are needed that specifically prepare physicians for treating patients with cell-based therapies for various organ systems and chronic diseases. The National Heart, Lung, and Blood Institute established the Cardiovascular Cell Therapy Network to design and conduct clinical trials that advance the field of cell-based therapy for patients with cardiovascular disease. As part of the network, a two-year Clinical Research Skills Development Program was supported at two centers with the goal of training early career investigators in cell-based clinical and translational research. In this review, we describe the implementation of this training program at our institution with the purpose of promoting the further development of academic fellowship programs in cell-based regenerative medicine.

©AlphaMed Press.
 
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