Anyone had MSC (aka Regenexx) done to knee and ski'd to tell about it? - Page 2

Edited by Finndog - 6/4/12 at 9:45am

Good points. I really don't remember the specifics of the technical details (see my post preceding). I just thought it was interesting to read that researchers felt that the placement of some type of stem cells in just the right location could be beneficial. In this instance the researchers were actually able to grow more cartilage, something I had always understood to be impossible. This isn't an affirmation of Regenex although it could be I suppose depending upon the similarity (if any) of their procedure to that employed by the researchers. My recollection is that this was definitely construed as an improvement on some similar type of procedure already being tried. For all I know they may have felt the Regenex procedure although promising was unsuccessful as it stands.

I have read that the use of stems cells to grow cartiledge is very promising as the chondrocite cells can basically "morph" into whatever part they are being grown as (Embyronic cells, not the same stem cells used in regenexx) . http://phys.org/news/2010-10-scientists-stem-cells-cartilage.html

 

if you are interested, its some good reading. The study claims it could be viable in 10 years.

 

I can't say the Regeexx process is an improvement as there are no studies to support or to compare. If the regenexx product helps some people that's great. Its just not known why or if the treatment itself works or that the prolotherapy aspect (healing response) is at work or even the plocebo effect is at play.  I think the future for us who are loosing parts is bright!

 

Very timely post Finndog, thanks for this.

 

One of my best friends and with whom i do most of my skiing is going for this procedure soon. He's been skiing since he was 2 (grew up in Montreal) and his knees are shot. One of the best skiers I know and I'm lucky to have skied with him 10+ days a year for the last 5 years else I would still be happy at Blue Mountain! His knees are so bad now he can barely ski groomers and he reckons if this doesn't work he's got MAYBE 5 years left before he has to hang them up.

 

They'll be taking bone marrow, centrifuging it to separate the stem cells then injecting his stem cell straight into the knee. He'll have to stay off the leg for a week or so to not crush the new cells. Then they repeat for the other side. He's had some success with a cocktail of growth hormone and other stuff injected into the cartilage the last few years but that's wearing off. It's a bit expensive too at $500 a shot I think (2 shots for each knee required...) but that's the price of doing what you love.

 

I'm sending him this link right now...

 

BTW - I read the thread from the beginning... Quite certain he's having this done at University of Western Ontario medical school. The ortho told him the procedure's being used by some pro football players (and I think some Alpine Canada skiers) but is still in the experimental stage. I'll ask him if he has any formal studies on it from the good doctor and will fwd/post if I can.

Edited by Canuk1w1 - 6/6/12 at 8:13am

well, that link is for a very different process. Again, stem cells are not all alike. I wish your friend the best of success.  Not sure how it could "wear off"?

Should've have said efficacy is wearing off - probably the damage in his knees is progressing to the point where it's of marginal benefit.

 

Yes, the procedures are a bit different - in his case they will be using his own bone marrow stem cells versus embryonic stem cells from another person. I've been away from molecular biology for too long so really can't say much as to the benefits/drawbacks of each. The embryonic stem cells are more "programmable" from what I recall. But unless the transplant your genome into them you're carrying someone else's DNA. If there's anyone in the forum with more current MGB knowledge, mayhap they can educate us on this one?

 

I think he's scheduled for the procedure in a month so we'll have initial feedback by the end of summer on how it feels.

if you read the article, it describes the process in detail.

 

The embryonics are cultured in a lab and "mixed" with the cells that they are intended to become, the other method of simply separating stem cells does not do anything except separate them from the blood.  Even if this process is a failure or sucess it doesn't really mean anything as there is nothing that shows if the process works or not.  Its not much different than the McKinsey protocol for back treatment....  If you know about that!

Finndog, I am with you on this -- VERY skeptical of the whole process. One reason why some medications are so expensive is that the company is recouping costs involved in getting FDA approval and to make profits before the patent expires. What is the cost to the clinician doing this Regenerex procedure? Why are the prices so high to perform it? I do know that there is a similar procedure that is being promoted to veterinarians -- after watching a free 2 hour on-line video, I can become certified in the procedure (really!).

 

While I am not skeptical of the efficacy of the treatment, I do agree that it seems pricey for what it is. However, the first microwave was really expensive, too. The cool thing is that if this does end up being as worthy as it seems, the price should drop dramatically, as competition  increases. Practitioners (as you point out) don't have to be surgeons. 

A question you may ask is since it doesn't require approval from any entity why aren't more people doing this? There are only a very few companies doing this. It does't take much technical know how since they are simply harvesting cells, spinning them in a centrifuge and re-injecting into a joint. I think the most technical aspect is the harvesting. I think most doctors are afraid to do this due to the liability exposure. It's not worth the risk of law suits affecting their practice.

 

Here's a pretty good article, not sure if anyone posted it yet.  

 

http://www.forbes.com/sites/gerganakoleva/2012/02/10/stem-cells-and-the-lawsuit-that-may-shape-our-medical-future/

 

 

...Centeno said his company welcomed the lawsuit because they anticipated it would finally give them a chance to formally question the FDA on its policy. Since then, Regenexx has been formally supported by the American Association of Orthopedic Medicine, the Association of American Physicians & Surgeons, legal and medical experts, and an academic who testified that one of the FDA’s own medical experts who criticized the technology had a competing device....

yes, the crux of the FDA issue has nothing to do with efficacy studies its whether or not the re-introduced cells once separated out of the blood and injected into a person should be considered a drug or not.  Did you read their published studies on efficacy?  (not safety)  here's a quote:http://www.ncbi.nlm.nih.gov/pubmed/18786777

 

"Mesenchymal stem cells are pluripotent cells found in multiple human tissues including bone marrow, synovial tissues, and adipose tissues. They have been shown to differentiate into bone, cartilage, muscle, and adipose tissue and represent a possible promising new therapy in regenerative medicine. Because of their multi-potent capabilities, mesenchymal stem cell (MSC) lineages have been used successfully in animal models to regenerate articular cartilage and in human models to regenerate bone. The regeneration of articular cartilage via percutaneous introduction of mesenchymal stem cells (MSC's) is a topic of significant scientific and therapeutic interest. Current treatment for cartilage damage in osteoarthritis focuses on surgical interventions such as arthroscopic debridement, microfracture, and cartilage grafting/transplant. These procedures have proven to be less effective than hoped, are invasive, and often entail a prolonged recovery time. We hypothesize that autologous mesenchymal stem cells can be harvested from the iliac crest, expanded using the patient's own growth factors from platelet lysate, then successfully implanted to increase cartilage volume in an adult human knee. We present a review highlighting the developments in cellular and regenerative medicine in the arena mesenchymal stem cell therapy, as well as a case of successful harvest, expansion, and transplant of autologous mesenchymal stem cells into an adult human knee that resulted in an increase in meniscal cartilage volume."  

 

Note they are referencing one single case that they hypothized resulted in an increase in cartilage volume.,  Note, there is no mention of how much over what time, etc.  this is basically saying we think our product works. 

 

I know, I was answering why more companies are not doing this yet.... ;-)

 

Thus my skepticism...

The uncool thing is whether this treatment has any long term deleterious effects -- studies for FDA approval are aimed at (helping) to answer this question.  What I was pointing out regarding the training is that I find it ludicrous that an invasive procedure (by definition) requires so little oversight.

OK, since this is a bit more involved, here's the description of all the different Regenexx treatments, not all are the same

 

http://www.regenexx.com/regenexx-procedures-family/

 

At least one is no longer performed in the US and is now performed in the Cayman Islands.  I think the regenexx-C is the one only done off-shore.

 

Regenexx-SD (Same Day)-A bone marrow based stem cell procedure. Spinning down bone marrow in a bedside machine produces a set amount of stem cells to be injected. Regenexx-SD can concentrate those cells many times over bedside centrifuges. In addition, adding super-platelet mix helps those cells multiply faster which grows more mesenchymal stem cells (based on in-vitro data). Unleash the power of your own stem cells!

 

Regenexx-AD (Adipose Derived)- The problem with using stem cells derived from fat (for orthopedic procedures) is that they under perform bone marrow stem cells. Having said that, there are more mesenchymal stem cells in fat than in bone marrow. If stem cells from fat aren’t as good, but there’s a lot of them, why not have the best of both worlds? Regenexx-AD was created to solve these problems. Here we take our traditional Regenexx-SD procedure with super-platelet mix and add a structural “fat graft” that’s filled with adipose stem cells. This graft can be used to solve structural problems within the joint. Regenexx-AD is having your cake and eating it too

 

Regenexx-SCP-(Stem Cell Plasma)-How do you get stem cells from a common IV blood draw? Our SCP contains concentrated platelets like PRP (Platelet Rich Plasma), but we’ve also gone the extra step to document that our version contains blood circulating stem cells of a type that have been shown to be capable of tissue repair. Learn more…

 

Regenexx PL-(Platelet Lysate)-Platelets slowly release their growth factors in a timed release fashion to help healing. However, there are times when the physician wants all of the growth factors contained in platelets immediately available to the area to prompt healing. In addition, there are areas of the body where using Platelet Rich Plasma (PRP) may cause too much inflammation. As a result, our physicians create Regenexx-PL by cracking open the platelets to allow all of the growth factors to be immediately available to your body.

Edited by Finndog - 6/7/12 at 1:02pm

 

I think they allow all these now; it's the C procedure performed in Cayman, and the one that my friends have done (when it was in CO) ... that's where they take out your cells, grow them in culture, and reinject.

more info- is this the one? 

 

OK, so this is exactly what makes me so skeptical.  The Cayman Islands, China and Argentina? seriously?

 

Regenexx-C-(Cultured)- In our non-U.S. Regenexx licensed sites (China and Argentina with Greece coming on line soon), we offer patients the ability to culture mesenchymal stem cells. At this time this is not offered at our clinic in Colorado.
 

I was going to write a longer reply the Finndog but see:  http://xkcd.com/386/

 

More seriously:

 

1.  Regenexx-C is just what they did for years and built data to show safety and efficacy on before the FDA decided that culturing (hence the C) made stem cells a drug.  While that's being litigated they could either (A) not offer what they thought was the best treatment and the one for which they had some actual data or (B) offer it abroad
2.  There are multiple published papers where in humans and animal models, you can isolate and culture stem cells, surgically implant them in a cartilage defect sealed in with a hunk or periosteum, and the defect heals (apparently better than with microfracture).  In the animal studies, you can implant appropriate stem-cell-free control and the defect doesn't heal
3.  Regenexx-C is just the same as #2 above but without the benefit of sealing the stem cells in AND also without the costs of the surgery required to seal them in. If your defects are inoperable (like mine because of location or being a narrow fissure not suitable for microfracture, OATS, ACI, etc), then it's nice to have SOMETHING that has very good reasons why it might help
4.  My knee is better after Regenexx than it was before BUT I WISH I COULD HAVE HAD THE C TREATMENT THE FDA DOUCHEBAGS FORCED OVERSEAS

 

If other people don't want to spend money on the procedure - fine.  If you have an issue that microfracture is like 90+% likely to fix quite well, stick to the tried and true.

 

But why are people determined that those of us without other options shouldn't be allowed to spend our own money trying to have better knees?  WTF

curious, is this approved anywhere in Europe? Why no clinics there?  Lets not throw the FDA under the bus here for requiring a company to justify their products offered to the public especially when they are asserting a cure-all product. The FDA does have it's issues but it protects consumers from fraud, deceptive marketing, counterfit drugs and more.  I am not a dr nor a lawyer but it does seem that when you remove blood and modify it, it does become a different material that what is was from the start.

 

They've been doing it in Europe for years. Pro athletes (including many skiers) go there to get treatment. Peyton Manning tried it on his neck last year. 

 

http://msn.foxsports.com/nfl/story/American-athletes-go-to-great-lengths-to-recover-from-injury-100611

 

 

I think this is a good excerpt ...  it shows that, you're right, there aren't the studies on this, but also, that it does work for some and it really doesn't seem to be dangerous.  

 

 

 

..."There is no secret that we are way behind Europe and some other places when it comes to stem cells," said David Geier, a South Carolina-based orthopedic surgeon and spokesman for the American Academy of Orthopaedic Surgeons. "But we like to try things, to be quite honest, that have a high likelihood of working. . . . There just haven't been the randomized, double-blind studies that show these treatments work."

Anecdotal evidence, however, seems good enough for athletes with the means. Geier said the only thing other than a possible infection at the site of stem-cell injections is money lost over a failed round of stem-cell therapy that can cost thousands of dollars.

"The biggest risk is that it doesn't work," Geier said.

Mark Adickes, a former NFL lineman turned orthopedic surgeon, said he'd like to have stem-cell therapy as an option.

"I hope some university has the opportunity to set up clinical trials," said Adickes, FOXSports.com's medical expert. "I think all physicians want that. I look at the research on the subject from around the world and I don't see how bankable stem cells (stem cells taken from the patient) pose any risk in an orthopedic procedure. Like anything else in medicine — including antibiotics or pain pills — it may work on one person and not work on another. Everybody responds differently. Stem cells could be the same way."....

This is Dr. Centeno, the physician who performed the initial research on Regenexx. First, the Regenexx procedure is just that, a medical procedure. Like the knee micro fracture procedure that uses stem cells to promote healing in cartilage, there is no FDA approval process for medical procedures as these are not devices nor are they drugs. Second, we've published long-term safety data on the procedure on 227 patients followed for up to 3 years and 339 patients followed for up to 4 years (see http://www.ncbi.nlm.nih.gov/pubmed/19951252 and http://www.ncbi.nlm.nih.gov/pubmed/22023622). Those papers showed better safety than common orthopedic surgical procedures. In addition, the second paper also included long-term improvement data showing that many patients who were deemed knee replacement candidates were able to forego knee replacement due to the stem cell injections. Regenexx is an innovative procedure that has been studied since 2005. In addition, we now have a host of doctors adopting the same day procedure here in the United States-see http://www.regenexx.com/find-a-physician/. Finally, our reason for moving the cultured procedure to the Cayman Islands is that our FDA believes that culturing your cells turns them into a drug, a position we vigorously oppose on many grounds, not the least of which is that the FDA has no authority to consider your stem cells as drugs-they made that one up. See http://online.wsj.com/article/SB10001424052702303815404577331673917964962.html-this is a Wall Street Journal editorial where the former FDA commissioner calls out the current FDA for trying to stop us from culturing our patient's stem cells. He believes the move cast a negative pall over the future of using your stem cells to treat your illnesses. On the discussion over athletes, we have treated and continue to treat many professional athletes. In fact, I just saw an NFL player last week that was referred by a team orthopedic surgeon for a major NFL team. That surgeon had vetted the science and felt strong enough about what we had to offer his player that he felt we could help. If you have any questions I didn't or can answer, don't hesitate to contact me at my desk e-mail-centenooffice@centenoschultz.com. 

Edited by Dr Centeno - 6/19/12 at 7:56am

Thank you Dr Centeno.  It's surprising to see you reply to this thread, and we appreciate some of the background for the decision to off-shore the therapy.  I hope you'll be able to check back, as I'm sure there will be more questions.

One of our patients is a part of the thread, so he altered me. I'm a pretty open guy who communicates freely with my patients via e-mail and would rather be part of discussions like this-especially since everything from the science to the regulatory issues are quite complex. 

Rockett any update or did FDA threaten u to stop

My orthopedist says that this FDA position on stem cell injections is just a legacy from the Bush administration's attitude toward stem cell research and that because of it the US is no longer in the forefront of knee and other orthopedic repair research. Elsewhere in the world apparently you can get this kind of and other possibly more advanced treatments. (without them having to engage in shipping your stem cells offshore to be processed)

Please pardon the hijack, but have any of you heard of/tried this treatment featured recently in the NY Times?: http://www.nytimes.com/2012/07/11/sports/athletes-with-chronic-pain-turn-to-novel-blood-treatment.html?_r=1&pagewanted=all ?  Called Orthokine in Germany where it was developed, it is offered here only in NY and LA under the label Regenokine.

 

Works on joints, knees and low back. Lots of celebrity endorsement, which doesn't prove anything, but my DH is thinking of going for it and it would be great to know if anyone here, not a pope or basketball star, had tried it.

 

Thanks.

Any update?  How did it go?

All the problem reduces to directing the stem cells to the appropriate location to start to differentiate into chondrocytes and produce collagen 2 or hailine cartilage. This can be done by new collagen gels or collagen binding proteins  bioengeenered to have growth factors fused  which attract stem cells to the endogenous collagen they bind to.. There are numerous patents claiming this can be done. I cite a recent study which  which just even recluting growth factors regenerated the cartilage: Northwestern University researchers are the first to design a bioactive nanomaterial that promotes the growth of new cartilage in vivo and without the use of expensive growth factors. Minimally invasive, the therapy activates the bone marrow stem cells and produces natural cartilage. No conventional therapy can do this..This extracellular matrix, which mimics what cells usually see, binds by molecular design one of the most important growth factors for the repair and regeneration of cartilage. By keeping the growth factor concentrated and localized, the cartilage cells have the opportunity to regenerate...There is more investigation going on than what Regenexx is doing which is even more promising than their selected stem cells (see Centeno´s patent on selecting stem cells)...

I'm two weeks out from having the stem cell injections on both knees, also had the fat injections as well which cost me just under 10G for both knees. Wearing OA braces on both knees right now as the stem cells have a chance to grow. I won't be able to tell for a month or two whether this was worth the money but right now for the first time in about three years I'm able to sleep through the night without any pain from osteoarthritis which was bad in both knees from a bone on bone condition. Happy to answer any questions anyone has about this procedure as I was very skeptical about getting this done cause I couldn't find any people posting "post" surgery? but wanted to try it before getting double FKR