Regenexx injections - Stem Cells

[plantgeek58]

I'm not debating the legal issues with you anymore. We simply are going round and round in circles and as you say, it will come out in the fullness of time. Just one final thought. Have you considered the terrible precedent it would set if this case were to come to court and the doctor were allowed to continue distributing this product without going through the proper procedures to ensure its safety and efficacy? It would open the floodgates for other companies, who may not be as scrupulous, to attempt the same thing. We could end up back in the days when physicians were able to make any claims they wanted about their products, whether or not they were true. Many thousands of patients in those days suffered because of it. I don't want to see that happen again, and that's why I feel so strongly about this issue.

As for testimonials, they have a tendency to give one a biased view, because they only encompass the people who have had success with the procedure. How do you know that these people are the rule rather than the exceptions? Reading all these glowing reports, it's easy to get fooled into thinking that everything always goes perfectly and you can expect near miraculous results. What about the folks who have not benefitted from the treatment or who have had indifferent results?  You rarely get to hear from any of them , which is why I've always viewed testimonials with a grain of salt.

I know there are a lot of people out there reading these posts. I mean, I'm happy that folks are finding the discussion between myself and Mccartjt useful, but I would really like to hear some other opinions on this subject. How about it people? Let's really open up the debate and see what others think about all this.

Terre

[Kaputt_Knee]

I'm jumping in Terre with my 2 cents!

I work in the medical devices field and have to translate documents for submission to the FDA prior to our products getting the OK. We are an OEM manufacturer of these devices - i.e. we produce the items for other companies to market under their brand name as well as manufacturing the same products for marketing under our sales name. We find that the FDA is very parochial at times - fast-tracking what they feel are home-based products and questioning identical products produced "outside" of the USA. So sometimes perhaps there is "home advantage" here. We produce devices for companies all over the world by the way and I am responsible for translating and editing all the regulatory affairs documentation required in English. So it is not just the FDA I have experience of.

I am also based in Germany where this stem cell treatment has been in use for some time, BUT only using your own stem cells. All research using stem cells gained from other sources is currently very heavily policed and largely illegal. For example the use of foetal stem cells is banned. So on one hand our legislation is behind that of the USA (use of foreign stem cell material) and ahead in other (use of own stem cells). I have had incorrectly placed tunnels in my knee filled with bone marrow taken from my shin by the way which is based on the same principle. The bone marrow cells will calcify to form bone.

The use of your own stem cells, harvested from the illiac crest (not sure of the spelling there, we call it the Beckenkam) is not that common but it is practised by a number of leading knee specialist practitioners here. Dr Jürgen Toft, formerly from the Alpha Knee Clinic in Munich is one leading knee surgeon using this technique. He has a book about arthritis and the various options for preserving the biological knee for as long as possible (available in English). For those who can read German, his new web site is up and running at this location: http://www.knie.de/start?t=1&ksid=53d0af615f2bff58bbeccc02233bb7b0. I am assuming that an English version will be produced soon. The change from the Alpha Clinic is due to problems that arose with the Spinal Surgery section of the Alpha Clinic by the way! Nothing to do with the Knee Unit. The old Alpha Clinic web site in English is also still available but for how long I do not know. The new site is pretty well a duplicate.

I am following the developments in this field very closely as I have been told that I am a candidate for a TKR in the future - I hope to keep that future as distant as possible. Currently my insurance does not pay for this treatment but have yet to establish why. It may simply be a cost thing I do notice that it is a procedure carried out largely on patients with private health insurance. I will talk to my surgeon about it to find out if I can about my options at a later stage. Fortunately according to him, I have no arthritis in my knee to speak of. However, 3 other surgeons who were in there as well say it is between grade 3 and grade 4 - go figure, I can't work it out! I like my new surgeon's diagnosis best! 

I think that the discussion should continue but let's leave the lawyers, emotional language, etc. out of it. Everyone has their own point of view, and sorry none of us are impartial, we all have our own points of view based on our individual needs and experiences. It would be nice to hear from people who have undergone this treatment personally, not just the references from glossy web sites! As someone says, no one is going to post about failures on their promotional web sites are they  It would also be interesting if a practitioner were to post but I feel that is unlikely 

Keep the discussion going guys please!

Sue  in Germany

[mccartjt]

Terre

My point has been all along that if you are not an attorney & have no direct knowledge of the discussions / letters / medical facts between Dr Centeno's clinic and the FDA, you are in no way able to give 100% accurate opinion.

You have stated previously that Dr Centeno's clinic & processes were " in violation of the law". & to date you've decided not to retract that statement, so please tell me, since when did you alone become a court of law in the USA?

Factually all the laws of the USA are open to determination, that is why we have "The Supreme Court" & the constitution. Why if there is nothing to debate would the Supreme justices ever sit and hear arguements?

As for opening the flood gates of dodgy procedures, there are  laws already in place already. How about this notion that "The Regenexx  procedure" turns out to actually be legal  as the law now stands? Where would your position then be? Would you want the laws to now change?

The way in which the FDA has approached his particular clinic is not unlike the financial termoil that is going on in the US economy right now.  Both have been handled IMHO badly! If the FDA had approached, & interviewed Centeno & co to understand the processes maybe the letters you've seen wouldn't be on a website right now either?

If you would care to read the FAQ on their website

http://www.regenexx.com/about-regenexx/common-questions/

In fact the clinic goes into great detail regarding "Is this procedure FDA-approved?"

[plantgeek58]

First let me apologize if I've begun to sound judgmental. I am trying to state the facts as I know them and my opinions based on those facts. That is, after all, what these forums are all about. That being said, I stand by every statement I've made. I believe that this procedure does fall under FDA jurisdiction. Obviously, so does the agency, or they would not have sent out that letter.

I did read the FAQ page. Here are a few of my thoughts about it.

Addressing the question of no interstate commerce involved in this procedure:  did I not read somewhere that another doctor is going to soon be setting up a clinic in Florida in order to begin treating patients there, using Dr. Centeno's technique? If he is teaching the procedure to other physicians, who are then going to be practicing in other states, does that not constitute interstate traffic? Sure seems like it to me. Take a look at question 42: 
"42.    Why don’t other doctors do this yet?  We are training other doctors in the technique. "

Regarding the FDA not approving surgical procedures:  What is ACI if not a surgical procedure? The FDA does regulate such procedures if they involve the use of products that come under the heading of new drugs or biologics. In my opinion, Regenexx falls into this category.

Concerning the statement that the doctor is simply practicing medicine as he is sees fit:  This procedure, in my opinion, is not part of standard medical treatment, but is an experimental new treatment involving a biologic agent. Again, I feel that it needs to have FDA approval.

Question 6 addresses the success/failure rate. It is stated that a survey was sent out and 80% of those who responded expressed satisfaction with the procedure. Pretty vague here. It doesn't mention exactly how many people responded to the survey. Only about 100 people have been treated so far. That isn't a huge database to begin with. What if only 10% of those surveyed responded, which is a pretty standard rate for surveys. That's just 8 patients. What about the rest? Surveys in general are not good indicators of success/failure rates. There are too many factors that can skew the results. Statistics gathered from followup studies tend to be more objective, but this procedure is so new, it will probably be a while yet before really accurate data is obtained. Again, just my opinion, based on what I've learned in my Probability and Statistics class.

Final thoughts-the whole arena of stem cell therapies is very new and it may well be that the current laws and regulations need to be changed to accommodate them. I do believe that there needs to be regulation, to protect the public, and I feel that the FDA is the best agency for the job, in spite of its imperfections. Doctors are human beings, and not all of them are trustworthy, which is why I feel that standards should be set that apply equally to everyone. These therapies are the wave of the future. They look to be extemely promising and yes, I do hope to be able to benefit from them myself. I would be happy to consider this procedure or something similar, but I also want to know that regulations are in place that will minimize my risk from it .

Sue, Danke vielmals fur die Auskunft. (Hope I said that correctly-don't know how to get the umlauts in there). You've made some interesting comments and pointed out some facts that I didn't know about the FDA and its attitude towards foreign-made products. Please keep posting with us. Every bit of information we get makes this discussion more useful, as Mayme and 60schild have said. And I will try to keep the debate from becoming personal.
I did visit Dr. Toft's webpage, but am going to have to come back to it with dictionary in hand. My German has gotten quite rusty from lack of practice.
I agree with you that it would be great to hear from someone who has undergone the procedure or from a medical professional. Anybody out there with those qualifications?

Terre

[Kaputt_Knee]

Hi Terre and any other interested parties!

the Alpha Clinic site with the English pages is still operating, even though the clinic is no longer functioning under that name

Here is the link http://www.alphaklinik.com/

There are some explanations in English but the German pages have more detail.

Have fun finding info and please pass on what you can - this is an interesting thread.

Sue in Germany

[60schld]

Hi everyone ,  I am finding all of this so interesting.  Kaputt_Knee I have heard from some
others out of country that our FDA is tends to be parochial.  I am very cautious and tend to lean
towards plantgeek58.  But since OA has fast been becoming one of our nations leading health
problems,  I think it would be in the financial interests of our big medical insurance companies to
reserve a section of their profits for the funding of these kinds of "new age", treatments.  I
believe if real money(which is what it ultimately boils down to) were to back these things, the
FDA might "fast track" more new procedures.  I don't know if it is any comparison, but look at
Bill Gates and his funding for research and treatment for AIDS.  I am grateful for Dr. Centeno
and Dr. Toft and whoever else can shed some hope for us.  Certainly, more money would help
to keep the research etc. a little less of a risk for all.      60schld

[mccartjt]

Terre

I am absolutely amazed, as here you go again, spouting your versions of legaleze. 

" Addressing the question of no interstate commerce involved in this procedure:  did I not read somewhere that another doctor is going to soon be setting up a clinic in Florida in order to begin treating patients there, using Dr. Centeno's technique? If he is teaching the procedure to other physicians, who are then going to be practicing in other states, does that not constitute interstate traffic? Sure seems like it to me. "

Do you actually know what the term of "Interstate commerce" means as it referred actually to in law, (& not your hypothetical conception of what the law might be,) vis a vis Dr Centeno's procedures?  I'll answer this one for you ~ probably not!

I have to say that am learning more about you Terre & I am going to make an assumption here, you are probably a salesperson, since every time I ask you a direct question you refuse to answer it. Yet you carry on back where you started from have yet another go at Dr Centeno & his clinic! That Dr Centeno & his clinic  is doing something that may directly & positively impact millions of peoples lives, seems moot to you.

Dr Centeno is regulated by the State of Colorado health authorities among others. If he steps out of line & breaks laws its his license to practice medicine that is on the line. As some one that has worked for years as any doctor has, you can rest assured that most of them won't intentionally break the law. That your knowledge of Dr Centeno's procedures & legal standing is lacking, is not my fault. Perhaps you should study proctophobia since your opinions come less than well thought out?

[mccartjt]

Terre

As for one of  your last comments, specifically about interstate commerce, Dr Centeno's website answers that question for any one who cares to read it..

http://www.regenexx.com/about-regenexx/common-questions/

"Rengerative Sciences Inc., (RSI) conducts all surgical procedures within the State of Colorado.  There are no interstate aspects to the procedures conducted by RSI that invoke FDA jurisdiction under the Public Health Service Act (PHSA), which requires an interstate nexus."

As for your opinion yet again...

Regarding the FDA not approving surgical procedures:  What is ACI if not a surgical procedure? The FDA does regulate such procedures if they involve the use of products that come under the heading of new drugs or biologics.

Per the FDA's  website

http://www.fda.gov/opacom/morechoices/mission.html
&
http://www.fda.gov/comments/regs.html

FDA is the federal agency responsible for ensuring that foods are safe, wholesome and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe. FDA also ensures that these products are honestly, accurately and informatively represented to the public. Some of the agency's specific responsibilities include..  It goes on..etc.,

No where does the FDA say on their own website that they regulate surgical procedures. They do regulate drugs that go over state lines as those then fall under "Federal" laws. If its interstate procedures its probably health boards of Colorado that have intervention. 

While we are getting educated here,  have a read here about defamation,

http://en.wikipedia.org/wiki/Libel

[Kaputt_Knee]

Terre

I am absolutely amazed, as here you go again, spouting your versions of legaleze. 

" Addressing the question of no interstate commerce involved in this procedure:  did I not read somewhere that another doctor is going to soon be setting up a clinic in Florida in order to begin treating patients there, using Dr. Centeno's technique? If he is teaching the procedure to other physicians, who are then going to be practicing in other states, does that not constitute interstate traffic? Sure seems like it to me. "

Do you actually know what the term of "Interstate commerce" means as it referred actually to in law, (& not your hypothetical conception of what the law might be,) vis a vis Dr Centeno's procedures?  I'll answer this one for you ~ probably not!

I have to say that am learning more about you Terre & I am going to make an assumption here, you are probably a salesperson, since every time I ask you a direct question you refuse to answer it. Yet you carry on back where you started from have yet another go at Dr Centeno & his clinic! That Dr Centeno & his clinic  is doing something that may directly & positively impact millions of peoples lives, seems moot to you.

Dr Centeno is regulated by the State of Colorado health authorities among others. If he steps out of line & breaks laws its his license to practice medicine that is on the line. As some one that has worked for years as any doctor has, you can rest assured that most of them won't intentionally break the law. That your knowledge of Dr Centeno's procedures & legal standing is lacking, is not my fault. Perhaps you should study proctophobia since your opinions come less than well thought out?

Mccartjt

To my mind it is you that sounds like the salesperson and this latest post is a personal attack on somebody who is honestly questioning why a procedure that enjoys success in many other countries and while not yet widely practised, is freely available, is not yet as freely available in the USA.

I'm sorry but you are repeating yourself with these replies, constantly referring back to the Regenexx web-site. Who else in any other state in the USA is performing this procedure? I've read the Centeno web site and I am curious about the possibility of using this technique to prolong my active life. Although allowed in Germany, we too have very few practitioners, as far as I know only Dr Toft in my area. Why is this when according to Regenexx it is only a surgical procedure? The general health insurance schemes here also refuse to pay for the treatment but will pay for expensive invasive surgery such as TKR and other such routines. I am absolutely certain that it is not all a dreadful cunning plot to prevent those without private health care to stay in the "dark ages" of joint surgery. According to the web site this procedure would save all health insurance schemes millions as there are no hospital stays, prolonged course of intensive PT or rehab centre stays and result in more people remaining economically effective and contributing their coffers. Even revisions would be cost efective according to the testimonials!

Sorry for the cynicism there - I'm a European and we are are cynics from birth, especially when it comes to dealing with public entities like health care! 

OK this is a new procedure, new ideas can be slow to catch on, but ligament replacement therapy has developed rapidly from none through artificial ligaments to autogenous now on to allograft in less than 25 years. Techniques have changed from major open knee surgery to minimally invasive in fairly record time - I know this from personal experience and have the scars to prove it  And that is from medical treatment in Austria, France, the UK and here in Germany, so I'm hardly being parochial/patriotic here!

Can we stop trying to score brownie points in Law 1001 and get on with the discussions about these treatment please. I would like to read about the culturing of the cells in vitro - what is used - does it classify as a surgical or a physical treatment? Does anyone KNOW why there is no federal acceptance but it seems to have local state level acceptance? I have read Dr Toft's glossy pages and I have read those mentioned here. Does anyone know of any other examples? Does anyone know if respected specialists who are moving in this direction (Steadman, Hawkins et al are also in Colorado aren't they?)?

Sue

[Saverio]

To All,

I am an actual recipient of regenexx back in March '08 and I posted my experience on this forum.  I am not getting into the legalities of tis procedure and the FDA.  I can only talk to my experience.   After the injections in my left knee, may I emphasize, it's only injections not surgery.  That in itself is a big relief since I have gone thru 4 knee surgeries without any improvement.   Dr. Centeno advised to not do any pounding for a month.  For the 1st month I could walk and bike.   After that I started to play tennis again and do some heavier rehab.  I could feel my knee getting stronger week to week.   Make a long story short,  I started playing singles again.  I just got back from regenexx for a 2nd bone marrow withdrawl.  I will be getting the injections in my right knee starting Sept 29.  A friend of mine also came out and will be getting injections in her right knee.   I will keep all posted on this website of our experiences.  BTW I was bone on bone in both knees.

Saverio

[mccartjt]

Sue & Saverio

Thanks for both for your comments. Whilst I have repeated myself it was on a point of provocation by Terre. Yes was my attack personal? Absolutely. When Terre (or anyone) sat in judgement of Dr Centeno's procedures in her mythical "Court" yes I did become insensed. Dr Centeno doesn't to the best of my knowledge post on this blog and has no one to defend him or his practice. I am against wild rumours because once started are almost impossibe to get under control.

I don't want to be talking law 1001, but people need to control what they are saying,

As for why the procedure does not fall under the FDA reguluations its probably because its not practiced "Federally" ie across state lines. You go to Colorado to get the procedure done. I can't even have the marrow draw done and shipped to Colorado. So no, the process intentionally does not fall  under FDA processes.

Medical insurance companies around the world pay for "Known" working medical procedures. They can't go out on a limb (or whim) easily. The story below of Viven Thomas is well documented

http://en.wikipedia.org/wiki/Vivien_Thomas

With out Dr. Viven Thomas's work millions of babies would have died. It takes guts to be a pioneer. Dr Centeno has clearly got strong opposition from Terre, here on this website. His clinic currently walks a fine line of legal arguement & medical science to get help to people with bad joints, bones and the like. Like I've previously mentioned I've been waiting 4 years for the FDA to approve MACI without success.

ACI is also a procedure that could be used in my condition, however my surgeon strongly recommended against it. To point "ACI is a procedure that you don't want the pain from" is precisely what my surgeon has told me for my particular condition.  My surgeon, also gave me his thoughts on what Centeno was doing, that he was extremely brave, ~ too brave for my surgeon's comfort level!

FWIW I have consulted with Dr Toft in Germany (& no doubt he does great work) I chose not go down his suggestion of treatment for my condition. There is, Dr David Karli of the Steadman Hawkins clinic who is involved with Centeno you can read his bio here

http://www.steadman-hawkins.com/physicianKarli.asp

Dr David Karli co wrote some of the papers published on NLH

http://tinyurl.com/5n4mvc

Finally I think I posted 3  links to Dr Centeno’s website which after all when we are discussing his procedures and techniques I don’t feel is excessive.

Saverio, finally to your points I wish you all the best with your procedures and recovery. Loss of knee cartilage is very difficult to deal with. I hope it turns out well.

For anyone else reading this blog, its important to do your own research as to the options / alternatives available for your condition and wish anyone that is in pain a speedy recovery from what ever ails you.

[plantgeek58]

Mccartjt,
personal attacks are not acceptable under any circumstances. I have repeatedly stated that my posts reflect only my opinions, I have twice apologized for anything that anyone might find offensive and I have tried to confine my comments to the issues at hand. Yet you continue to take pot shots at me. I have asked the moderators to look at this thread. Until I hear back from them, I will no longer be posting here. If and when I do return, it will be only to respond to others' postings.

I do hope that everyone else will continue the discussions. Saveiro, I would be very interested in reading more about your experience.
Terre

[Kaputt_Knee]

OK we have an actual recipient on board.

Saverio, can you please explain how you came to this therapy (why, etc., if possible) and exactly how it all panned out? There are many of us here who have, for whatever reason, only here say on which to base our own opinions. Not exactly informed opinion really when you analyse it  I am, despite my profile info, almost 58 and have almost all the medial meniscus in my left knee shaved away. The lateral is very healthy and not in need of any TLC from some demented "salami slicer" of an orthopaedic surgeon. The discrepancy between the two sides is going to cause me problems. I am and always have been a hyperactive sports fan (Phys Ed teacher, ski instructor, national level volleyball player, diver, paraglider, climber - get the picture?). I want to continue for as long as possible with most of my sports - OK I'll give up the volleyball and field hockey! But the skiing and mountain based sports - NO WAY JOSE  I live in the Alps for God's sake - why should I?

Please can you explain more about the actual processes involved as YOU UNDERSTAND them. What would be of particular interest is any personal evaluation of "before & after", how the pre-procedure evaluations were carried out and most importantly what you feel about the effects on your body at the time of your treatment and subsequently.

You have only been in this situation since March this year, so only a maximum of 6/7 months max.: with the best will in the world this is hardly a long term evaluation  Do you feel that you will need further injections to resolve your particular problems?

Mccartgt - please if you want to gnaw away at something, please do it elsewhere as you are currently doing nothing except souring an open and adult discussion about an interesting new procedure. I have looked at all the links you have posted but currently view most of them as, at best interesting but not that informative, and at worst simply advertising similar to that of the quacks that turned up in towns and beat their own drum! It is very easy to take pot-shots on forums such as this, but a little more constructive discussion is what most of us would appreciate.

Terre, I have also reported the thread for monitoring but not to be locked as I feel with a little less emotion we could all learn something here.

Sue

[60schld]

Yes I'd like to chime in . Saverio, what happened to you?  How are you feeling?  As you
can read from this thread, we ALL want to know!!  Write soon

[60schld]

My computer/ browser was not working for a while.  thanks Saverio, I just found your latest
post.  How encouraging !!