Follow Me on Pinterest

Tuesday, February 3, 2009

Regenexx vs the FDA 2009

Last year I blogged a couple times about Dr. Christopher "the renegade" Centeno from Regenerative Sciences, Inc (aka "Regenexx"). He's in Colorado collecting, growing, and re-administering stem cells for now a growing list of orthopedic-related conditions.



As previously discussed on this blog, FDA CBER's Mary Malarkey sent a warning letter in July 2008 to Dr. Christopher J. Centeno, Medical Director of Regenerative Sciences, Inc (RSI), doing business as Regenexx. The company responded on its website that they do not fall under FDA jurisdiction. One of the reasons cited is that their entire procedure occurs within the state ergo no interstate commerce ergo no federal jurisdiction.

The good doctor (aka @stemcelldoc on Twitter) is not only rapidly expanding the indications for which he'll pump you up with stem cells, he is really ramping up his marketing. He is actively promoting his services on the internet (blogging, a Twitter stream, etc) encouraging people to come from all over god's green earth to visit Colorado and get shot up with a dose of their own stem cells.

Now I know that archaic legal paradigms weren't designed for this new-fangled world but according to a good ole fashioned sniff test many would say that smells a lot like interstate commerce to them.

This is not a critique of the Regenexx therapy, Dr. Centeno, or the company. I'm not saying the Regenexx therapy doesn't work. I'm betting it does. I'm not saying I wouldn't be tempted to go if I had joint problems. I likely would. I'm not saying what they're doing is wrong or even illegal - sometimes it takes a gutsy cowboy/girl or two to change the rules for good. BUT if the FDA lets this happen in Colorado it seems to me a slippery slope to letting all autologous cell therapies go unregulated. And I don't see that happening any time soon.

Rumor has it Regenexx is planning to open a new clinic in Florida. There's the slope in clear sight.

On other fronts, there have been reports of the Regenexx therapy being reimbursed by at least one insurer. Aside from the FDA, this is quickly gaining all the hallmarks of a legitimate medical procedure. As of November, they had performed 250 procedures.

In September last year Dr. Centeno posted on an online discussion board:, "To set the record straight, we have been working with regulatory council for 3 years on our needle based, surgical procedure. We have responded to the FDA unititled [sp]letter and we believe we have answered all of their questions. This is a surgical procedure and not a new biologic drug. We have been communicating with the FDA and they have had no response, so we assume that we have answered their questions."

The FDA may not have any more questions but unfortunately I doubt that ends the issue.

Interstate commerce aside, Regenexx appears to be manufacturing a biological therapeutic. While they appear to have taken references to cell expansion or manipulation off their website, according to a recent blogger allegedly quoting from a letter from the company, the stem cells are collected, expanded (at minimum) and reinjected. The letter apparently stated: "The procedure involves drawing our patient’s blood and bone marrow, growing their stem cells in our laboratory for approximately 3 weeks and then injecting the stem cells into the affected joint".

If this is true, it seems to me this is not just a doctor doing his doctor thing and the big, bad FDA should let a doc be a doc. This would be a doctor manufacturing a biologic without any of the manufacturing controls created by regulatory agencies and industry to keep such things safe - safe, for instance, from contamination.

If there are no such controls in place god only knows what kind of back-alley operations might come to town selling stem cells from basement labs. It is not far-fetched. If this is allowed to continue, other docs will get in this business. Some will decide they just want to run the clinic not grow the cells. They outsource that to company X which is being run by some half-baked science dropout who decided this is probly better money than making meth so let's start a stem cell grow-op! Ok, that's the extreme but you see my point.

I've got a lot of sympathy for people who push against the rules. I believe Dr. Centeno and his company are doing what they believe is right and I'm sure they are doing everything they can to ensure their product is safe and efficacious. I also believe that in years to come we may well be comfortable enough with these types of products that this may well be as commonplace as Dr. Centeno would have it but I don't think it will be in his lifetime. At least not in the US. I kinda hope I'm wrong.

We can't simply let the market decide which therapies will succeed. We need a minimum level of safety assurance and oversight by an agency like the FDA and without any controls how long is it before someone perhaps not as diligent or trained as Dr. Centeno makes a product that does more harm than good?

I think the FDA is building its case and a showdown is on it's way to Denver-town.

30 comments:

Alexey said...

"If this is allowed to continue, other docs will get in this business."

that's exactly what happened in other countries, in Russia for instance, where there is no such powerful regulatory body as FDA.

Another issue that I actually asked you before is that where is a border of the "cell therapy product" = drug, which suppose to be regulated by FDA and "unmanipulated cell suspension" - let's say 5-24 hours after progenitor cell isolation/enrichment by "whatever device" (ex. Isolex- Baxter or Harvest), which is not apply like a "cell product" and not supposed to be regulated by FDA?

is it written somewhere in FDA documents?

thanks

Lee Buckler said...

Alex,

Firstly let me say I'm no regulatory expert but as I understand it the FDA distinguishes between cGMP and cGTP products. This determines the regulatory pathway a product will be regulated under. GTP products do not have to go through a BLA (biologics license application) to get to market. There is a list of I believe 5 criterion that determines under which category a particular cell therapy will fall. The two most cited are "minimal manipulation" and "homologous use". Both are very loaded terms around which there is much discussion and debate about in terms of how the FDA defines the terms and applies the definitions. I don't think it will be as simple in the US as any product that only goes through this kind of process can be used clinically for anything.

--Lee

Chris Centeno, M.D. said...

Lee,

A patient came across your blog today. Given the nature of the content, I thought it important to respond to your post.

To set the record straight, the FDA sent us an "untitled" letter, not a warning letter. Their own information states that such a letter is to be sent when the FDA is unsure of it's regulatory authority. We responded to this letter some 6 months ago and the FDA has not responded to our answers to their concerns.

We run a state of the art medical facility that has undergone a full, voluntary Reglera cGTP review and passed with flying colors. The medical procedure performed within our facilities compares very favorably with the ISSCR guidelines. While you bring up some interesting points, embryonic stem cell expansion is performed everyday in countless non-FDA regulated In-vitro Fertilization labs in the US, without issue. The practice of culture expanding autologous bone marrow cells to reconstitute the immune system of irradiated cancer patients is just beginning, again without FDA involvement and usually under the auspices of state regs.

Our procedure was first successful in a university based, large animal model. We spent a year porting that to human patients under the auspices of an Institutional Review Board (IRB).. We began treating commercial patients only after an additional year of IRB approved research (which continues). We don't add new areas of treatment until after our research has shown imaging and patient reported evidence of efficacy and safety. As a concrete example, my initial interest as a pain management specialist was treating lumbar degenerative discs. However, just copying the successful animal model into humans didn't work. It took three years of tweaking the procedure until we could get it to work reliably in a subset patients. Hence the procedure for discs wasn't begun on commercial patients until recently and then only with specific inclusion criteria. As a result of these experiences of what will likely work and what won't work, we categorize all patients as either GOOD, FAIR, or POOR candidates based on pathology. As an example, only about 25% of our joint patients are prospectively placed in the GOOD category, 50% in FAIR, and 25% in POOR.

We also employ a nurse to maintain a patient tracking database that is >3 years old and now contains 200+ patients, 50 or so of these have also had pre and multiple post-op 3.0T MRIʼs of the transplant sites. This safety data has been submitted for scientific publication. So while I donʼt dispute that like anything in medicine, practitioners can enter the field who may not be reputable (i.e. a surgeon who is not well trained or an IVF lab opening that doesnʼt do a good job of handling cells), we take our practice of medicine very seriously.

Chris Centeno, M.D.

Lee Buckler said...

Chris,

Thanks for posting the comment. I appreciate your record of active transparency and online participation.

Curiously enough, the FDA didn't sound that unsure of its position when it stated in the letter "your implantation of the mesenchymal stem cells for which a valid license or IND is not in effect appears to violate the Act and the PHS Act and may result in FDA seeking relief as provided by law."

It also seemed fairly clear of its position when it said, "We request that you notify this office, in writing, of the steps you have taken or will take to address the violations noted above and to prevent their recurrence."

I certainly have every reason to believe that you are running a very professional, state-of-the-art, ethical, medical business with an outstanding facility and adhere to nothing but the best practices at all levels.

I also happen to believe your product is one which falls under FDA regulation with which you are not complying. I happen to believe what you're doing is beyond the practice of medicine and not simply governed by cGTP rules. I suspect that is also the FDA's position but time will tell how this plays out.

I certainly have heard nothing but good reports about you, your clinic, your product, etc. I also believe that you are doing everything right to try to build a case of scientific and clinical credibility - in terms of long-term follow-up, publications, clinical transparency, etc.

I'm not sure I understand or agree that ESCs are expanded in IVF clinics. There seems to me to be a fundamental distinction between growing blastocysts to a more viable stage for implantation and growing ESCs.

I'm also not convinced that if clinicians are culture expanding autologous bone marrow cells prior to transplant that this will be allowed to continue "without FDA involvement"

I think it is a commendable business practice that you paid to bring in Reglera to inspect for cGTP compliance. Whether or not this is a cGMP product is the remaining question.

I want to be very clear. I would encourage no one to change their course of action or opinion regarding Regenexx, yourself, or RSI based on anything I've said or say.

It may well be that the FDA considers this matter completely resolved. I have no way of knowing. I am a passive observer like any member of the public watching this transpire.

I have no reason to believe that you are anything but an excellent doctor with the highest standards and that Regenexx is and does everything it is claimed to do.

I believe RSI and FDA have a difference of opinion and I am keen to watch what, if anything, will happen. I have stated my opinion of what I think most likely but I may well be wrong and - as I've said before - I actually kinda hope I am.

Again, thanks for the post. I appreciate the dialogue and I will be watching your future with great interest.

--Lee

p.s. For those who are interested in this issue it may be of useful to know in the most basic of terms there is provision by the FDA for products which are only 'minimally manipulated' to be sold to patients without getting formal FDA approval for the product / treatment. There is a similar provision in other countries.

In Germany, for instance, the XCell-Center (http://www.xcell-center.com)provides (sells) treatment to patients for several conditions.

They do not, however, expand the cells they collect. They isolate and separate cells from the bone marrow collection but they do not then grow cells.

This is the fundamental distinction and what may be (I predict will be) why FDA takes issue with Regenexx.

abs said...

Since he is not affiliated with a medical center or university, I was wondering what IRB approves his studies?

Also, I have seen his posts showing increased cartilage after injection. Does that correlate with decreased pain???

Any placebo-controlled trials going on to compare the stem-cell treatment to natural history of the problems being treated????

Anonymous said...

Lee,
I agree with your viewpoint on this subject completely. As a member of the online discussion board to which you alluded, I tried to express my concerns about the lack of federal regulation for Dr. Centeno's product, but was ridiculed and forced to withdraw from the discussion due to personal attacks from one of the other board members. I was extremely pleased to run across your blog and will be interested to read future posts on the subject.

Lee Buckler said...

Excerpt from http://celltherapyblog.blogspot.com/2009/03/cell-therapy-industry-hilites-2009-03_27.html:

In keeping with the biblical proposition that "nothing new is under the sun", a new physician group as been formed to "oppose FDA's position on adult stem cells". The newly formed "American Stem Cell Therapy Association (ASCTA)" this week posted its manifesto online and issued a press release saying the "organization was formed in response to the Food and Drug Administration's (FDA) recent position that the adult stem cells found in everyone's body are drugs, a position the ASCTA opposes." I'm not sure which move the FDA made recently that would make these docs think this is the FDA's recent position.

As I wrote on this blog back in September last year, doctors have been trying to tell the FDA that cell therapy is the "practice of medicine" for years and it hasn't worked. Of course, it will come as no surprise to you that central to this new movement of doctors lobbying for the right to treat patients with their own stem cells however they see fit, is Dr. Chris Centeno of Regenexx and other doctors like Dr. Zannos Grekos who are involved with stem cell treatment clinics marketing to US patients for clinics performing their magic outside the USA.

In a classic case of overstating the point, ASCTA member Dr. Frank Falco states, "The FDA's position against someone using their own stem cells is taking it too far." Of course, saying that is the FDA's position, is taking his point too far but subtleties like that don't get people engaged in a revolution!

Lee Buckler said...

Not settling with organizing doctors against the FDA with his "American Stem Cell Therapy Association (ASCTA)" (see my previous blog comments), Dr. Christopher Centeno is now inciting patients to oppose the "FDA's position that the patient's own adult stem cells are drugs and should be regulated as such."

To facilitate patient activism he has launched a patient web-site, www.safestemcells.org, to drive the activities and opinions of patients in what he's calling the Safe Stem Cells NOW! movement.

The Stem Cells Now! movement's goal? "To inform patients and physicians that their ability to access safe stem cell treatment is being heavily restricted by pharmaceutical industry agendas and by the FDA."

He has also recruited the enthusiasm of Barbara Hanson, co-founder of www.stemcellpioneers.com, who is quoted as saying:

"Adult stem cells are cells from our own body. They are very safe. There are no moral or ethical issues. They are safer than taking aspirin and yet the FDA has classified our own stem cells as drugs that require regulation. This means that prolonged investigations, including lengthy clinical trials, will be required for each and every disease and application that adult stem cells could be used for. This could take years and years. It smells of big pharma to me and many others."

For my other posts about the work of Dr. Centeno, see "Cell therapy is not the practice of medicine" posted in September 2008.

ab said...

Did you see that Centeno tried to keep all FDA proceedings confidential?

http://www.regulations.gov/search/redirect.jsp?objectId=09000064806cd637&disposition=attachment&contentType=pdf

And it got denied!

http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=090000648073bea8

He had his first day in court last month. It sounds like it was only a stay of motion. Will be interested to see how this turns out!!!

http://dockets.justia.com/docket/court-codce/case_no-1:2009cv00411/case_id-111707/

Lee Buckler said...

How long have we been hearing that Cheerios reduce cholesterol in their "give us 6 weeks" ad campaign? Yet only now has the FDA sent a warning letter to General Mills.

http://www.fiercepharma.com/story/cheerios-available-without-prescription-now/2009-05-13

Just because the FDA is slow in its enforcement, doesn't mean it won't ever get around to it.

--Lee

Steve said...

Let me start off by saying that I am a biochemist from New Jersey and I fully support the work that the good doctor is doing. I myself have a knee injury that could be helped by this treatment, I just don't have the money for it right now. My doctor is trying to open up a facility in New Jersey with him to do this procedure. The FDA is being leaned on by the big pharmaceutical companies trying to block this research. The reason for this is that these companies want to make money off of the procedure. They want the cells to be grown up in their facilities, i.e. all cells for this procedure would have to be grown up in a Pfizer lab (just using Pfizer as an example). The FDA recently ruled that taking the cells and injecting them the same day is not a drug but taking them and injecting them on a different day is a drug (makes a lot of sense right?). All of this is about money and the stigma attached to simply using the word stem cells. Even though there should be no ethical objection to this procedure there will be simply because of people's ignorance to the facts behind the issue. I truly hope that one day someone will have the courage to fund this so that this treatment could be accepted by insurance companies so that it can be available to all.

Lee Buckler said...

Steve,

Thanks for the post. Just a few comments in response:

1. The FDA regulates treatments, not pharma companies.

2. Profit is not an evil motive and if it were your doctor would be judged in the same way you judge pharma co's. Most docs would not be so eager to provide this treatment if there wasn't good money in it.

3. To the best of my knowledge, your statement about the FDA's regulation of same-day vs next-day use of stem cells for treatments is wrong or at the very least a very simplistic mischaracterization of the regulation.

4. The issue of whether these kinds of treatments should be regulated by the FDA has nothing to do with "stigma" or "ethics" and everything to do with safety.

5. There are dozens of states, universities, donors, and companies funding the study of autologous stem cells for all kinds of treatments. Insurance companies will reimburse products/treatments which are proven to be safe, effective, and are provided in compliance with FDA regulations.

--Lee

Klaus said...

Let's not talk about the FDA like they are some sort sanctified body. They have approved thousands of drugs which have resulted in the deaths of thousands of people. Please spare us the notion that they are looking out for the safety of us all. It's all about the FDA and the profits of big pharma.

Steve said...

Lee I have to disagree on a few points.
1. Actually I never said they regulate companies, they get lobbied by companies. And they do regulate companies, ask any researcher who has oversight from the FDA.
2. I never said profit was an evil motive but there is no reason for the doctors to send out these cells to pharma companies, the fact that pharma companies are being denied money for it is causing them to lean on the FDA. Sending these out to pharma companies will only drive up the cost as pharma companies increase cost on items largely to recoup lost money on research.
3. Yes, my explanation was simplistic, to state it a little more in depth the FDA ruled that taking your own cells, isolating the acceptable stem cells and injecting them somewhere else in your body on a different day is a treatment. Trust me I work with multiple cell lines everyday and by proliferating them you are by no way altering the cells themselves (the vast majority of the time, there are some primary cell lines that do alter with increased passage number, but none that alter with the low levels of passage the doctor uses).
4. If safety was the real issue the FDA would request some early phase clinical trials, and I have never heard of a person rejecting their own cells. And stigma has a lot to do with it because if you ask the common person a lot of people will say stem cells are wrong.
5. There are countless examples of insurance companies refusing to reimburse for care.
However, I will agree with you that some regulations are in place for the safety of the people. For example, not allowing stem cells to cross state lines is one example as it prevents illegal trafficking of these cells which there surely could be a black market for. And believe me, I may have come off this way, but I don't believe pharma companies are this big evil entity. I understand why their costs are so high for certain items. In my own research I have spent large sums of money, and I fully understand how much research fails. I would like to thank you however for your differing viewpoint, I do feel that discussion about this matter is important and all view points need to be taken into account when a decision on something this important is made. I just hope the folks with the power to make the decisions are having a discussion like this.

-Steve

Anonymous said...

Dear Mr. Lee Buckler,

What is your personal interest in highlighting this issue? What is your career back ground that gives you qualification to discuss this issue with some authority?

I am a prospective patient and I admire What Dr. Centeno is doing. I can assure you that FDA under Obama Admin will be different that what we had in last 8 years, if not, there will be a patient revolt in support of this procedure. We already have enough garbage regulation from FDA that has approved thousands of drugs most of which are harmful for patients. We also know that many former FDA employees are consultants and paid employees of big pharma.

From what I read in this blog and your posts, I will tell you point blank, you are either from the bible thumping group opposed to stem cells for no good reason, or you are paid by big pharma, or both.

Anonymous said...

Dear Mr. Lee Buckler,

Ok, I looked up your background. You are an attorney and consultant in this area. May be you would like Dr. Centeno as your client to fight against FDA, who knows. I hope that is your motivation.

The more regulation, the more money to be made by expert consultants like you. I just hope that you make your living without hurting us patients.

Dr. Centeno is doing good work with a lot of courage going against the establishment who is there to benefit big pharma and the legal experts. Patients like myself and others will always come to defend him. FDA or your type will have a tough fight. Just think that one prospective patient can be so supportive of him, imagine what will happen when so many thousands will benefit from this treatment and millions of others who will want this treatment. Sorry but FDA or your types will not be able to stop or regulate this by twisting current laws and will have very very hard time if any new regulatory laws goes to congress.

orthsurg said...

Manipulating , or expanding bMSC's, bone marrow derived mesenchymal stem cells through multiple passages to get increased numbers of cells:
1) decreases the ability of those cells with increased passages to differentiate, i.e., that is to become a cartilage cell(chondrocyte) and produce the associated extracellular matrix, i.e., appropriate collagen.
2) There is absolutely no evidence that shows that those increased number sof bMSC's are needed. These are progenitor cells and as opossed to adult chondrocytes, dont need to be expanded, to be efficacious. Chondrocytes , must be expanded and "Carticel", I procedure that I perform, and a portion of Genzyme , underwent extensive FDA Regulatory approval for multiplying the chondrocytes in a culture dish to 12 million, so that I may reimplant.
3.) Recent studies by this group have only proved that it is "doeable" and safe, not that it is efficacious.
4.) These ar enot surgeons and there follow-up with imaging techniques, for cartilage regneration, is by no means the "Gold-standard". Arthroscopy re-looks, biopsies with antibodies to the apropriate collagen and histology with electron microscopy is the "gold-Standard".
5.) Efficacy of this needle procedure has not been shown in this fashion.

Bennettorthopedics.Com

Anonymous said...

Orthsurg.. stick to be a surgeon, you're not a scientist by a long shot. We get that this procedure threatens some of your livelihood (made through barbaric techniques that pale in comaparison to stem cell procedures). Perhaps you are not quite as stupid as our friend Lee, but are certainly approaching his dullness.

By the way, Lee, I know you get some jollies out of being a two faced ass who tries to stroke Dr. Centeno's ego, while insulting him, but try being humble. (Even if you are being funded to be disruptive) You're a lawyer? Let your betters discuss the science, as you have no right to enter this arena.


1) You are actually correct on this point. Amazing.. maybe you didn't buy a degree.

2)Umm. WRONG. They do need to be expanded, despite the fact that they are pluripotent in nature, and not fully differentiated, especially for large, full thickness cartilagenous defects.

3)No, you blind, ignorant fool. There have been more than a few case-studies that have proven the efficacy of the procedure. You might also want to try a pubmed search for once. You know.. pubmed.. central database for.. well just about anything to do with the biological sciences? Also, did you actually go to the website and do some reading?

4) Yes, arthroscopy and subsequent histological analyses would be helpful, but you're just being as stubborn boy if you can't admit that patient response in conjunction with MRI is a good indicator.

5) What the heck do you mean by this?

All-in-all, do the scientists a favor, and just observe, instead of speaking.

Anonymous said...

Centino is doing something ALL doctors should start doing... caring and treating the patient as best as possible no matter what the treatment may be.... U.S. system is all messed up.. they profit off people getting sick and dying!

There will be two people; the sick that are willing to try and the others that don't and may die quick.

Lee Buckler said...

Errata Statement re: Regenexx

It has been pointed out to me by legal counsel that the 25 July 2008 letter from the FDA to Regenerative Sciences, Inc regarding what FDA observed as apparent "violations" of FDA regulation by Regenexx, was not a "Warning Letter" as that term is officially defined but rather an "Untitled Letter" which has less or no formal effect.

My previous reference to the letter as a "warning letter" was a colloquial rather than legal use of the term. In any event, to avoid possible confusion, I hereby formally point out that the letter was not a "Warning Letter".

Despite the FDA's observations of what it then said appeared to them as Regenexx "violations" of FDA regulation in that Untitled Letter, since the date of the letter the FDA has not followed up with any Warning Letter, Cease and Desist Letter, or sought any other relief in court either in an action of its own or in the action brought against the FDA by Regenerative Sciences, Inc.

This fact has emboldened many to believe that the FDA will not take any action to remove Regenexx from the market despite its observations in 2008 that Regenexx appeared to violate the existing FDA regulatory framework.

Some take this one step further and believe that by its lack of action the FDA has demonstrated it now believes the product does not, in fact, violate the regulations. Others are convinced the FDA's lack of action is merely a lack of action and not a change of conviction. In the face of a lawsuit by RSI, after all, the FDA has to pick its battles carefully.

Only time will tell...

Anonymous said...

The use of human cellular and tissue based products (including adult stem cells) falls within FDA jurisdiction under 21 CFR 1271 -- regardless of whether the product enters interstate commerce. I'm not sure how the Regenexx physicians can interpret this regulation in an alternative way. A check on the FDA CBER page does not list their organization as a registered tissue establishment, which is an additional requirement under the FDA regs.

Is their position simply that FDA's regulations at 1 CFR 1271 exceed the agency's authority? Or is it that the FDA regulations do not apply to them?

Anonymous said...

If it is helpful at all, at the World Stem Cell and Regen Med conference in London yesterday, Dr. Steven Bauer, Chief of the Cell and Tissue Therapy Branch for FDA CBER was asked a specific question regarding situations like this by Chris Mason of UCL. He replied (paraphrase): "Our regulatory authority descends from statutes which specify situations of interstate commerce and is thus limited in certain situations."

From that I would understand them to have looked at this very closely and eventually agreed with "practice of medicine". Note that we might not have the use of LIMA in cardiac bypass today if we required prospective sponsored clinical trials to allow its use. There are many other examples that fall in the grey area. We certainly regulate and oversee entire organ and tissue transplant successfully under PHS with facility-only qualifications, a regulatory structure that avoids holding back innovative therapies and yet can address all of Lee's stated concerns.

Lee Buckler said...

Well I never said the FDA would be quick but apparently there was some truth to my Feb 2009 prediction that "the FDA is building its case and a showdown is on it's way to Denver-town."

Click Here

j said...

I'm confused, this is a patented procedure correct? If it is a patented procedure would that not limit the opportunity for "kooks" to perform this procedure? That said the FDA has not stated that this is in any way a actual violation of any kind, why the hold up? This strikes me as a deterrent that would only help the continued sale of drugs, as well as medical procedures that would clearly become obsolete should Regenexx become an option.

I am also surprised that the insurance industry is not helping to move this forward, would it not save them billions of dollars spent on orthopedic treatments?

I have degenerative disc disease, which oddly enough is the diagnosis I received after a spinal injury that did not heal, at the age of 27 I was told that I qualified for a three level spinal fusion. I have suffered a great deal of pain, discomfort and frustration which has significantly reduced my quality of life for over a decade now. I certainly hope that this procedure is approved before my spine becomes unrepairable. I have put off surgery hoping that advancements in medical technology would bring about a better option. Regenexx appears to be that option. I loath the thought of suffering for years while the FDA sits on this issue, instead of addressing it with the diligence that I, and anyone else suffering deserves from a professional administrative organization, after all the FDA's own mission statement is:



“The FDA's mission is to promote and protect the public health by helping safe and effective products reach the market in a timely way, and monitoring products for continued safety after they are in use. Our work is a blending of law and science aimed at protecting consumers.”



Perhaps I need to participate in a clinical trial. Is such a thing possible?


J.M.S. CO SPRINGS CO

stephen bertoldo said...

hi did a regenexx treatment travelled across half the world to do it and i tell you honestly this procedure works and yet when your faced with the alternative like chop your knee out or whatever the other butchers out there are prepared to do because they have the fda behind them i wonder what threat they view this method of treatment to their secret society little world because its so much easier and less complications can happen like blood clotting infection or not working at all etc,they blame all other excuses they can think up,ive had a couple of failed repairs which all they do is take out for once someone puts something back in leave him alone to excell in this method of therapy its no different to a skin graft coming from one part of the body to repair another,i hope to return for a follow up procedure because my knee was so bad that whatever missed out the first procedure will fix up the rest but it feels pretty good 100% better than limping around like a china man or to scared to sit down because when i would get up i couldn't walk properly for half an hour and always had a limp plus pain every minute of the day mate hope these guys get a huge medal they deserve it and i hope the fda reads this i have a brother who had a hip replacement ie johnson and johnson company and we all know where that went investigate that more that is criminal but thats ok there a world renowned company who made bandaids famous and everthing else can go through untested because they pay off these boards to get their products through good luck regenexx your like a bit of good in a whole big bad world regards stephen bertoldo

Chris said...

Regenexx has been trying to force the agency into court for two years and they have refused to discuss why a medical clinic practicing medicine using a patient's own tissue is producing a drug that is regulated by the FDCA. I wonder why they couldn't speak to each other and put an end to all that?

Richard Watkins said...

Stephen Bertoldo,

May I ask where in the world you went for your Regenexx treatment? I've been suffering back and leg pain for 10 years, it's getting worse, and I'm getting desperate. I don't want to eliminate my opportunity to get a real cure by doing surgery. I would like very much to see the Regenexx treatment approved, and do wonder why the FDA doesn't approve it quickly. On the surface, it doesn't appear to have any downsides.

To Anonymous dated March 1, 2010 6:26:00 PM PST
I consider your comments personally offensive and not helpful. Hypothesizing about peoples motives without evidence, and calling them insulting names, proves nothing. It only makes people angry. The reason Lee is agreeing with Chis on some points and not others, is because he is trying to be objective and give credit where credit is due. That is the way professional people discuss topics on which they disagree, and he deserves respect for that. This blog will lose it's value if people say things only for the purpose of creating hurt. I'm on your "side" of this issue, but please, stop posting unless you can add value. Adding value means disclosing new facts or new analyses, and acknowledging points on which you can agree. Thank you.

Richard Watkins

Anonymous said...

Lee Please update where is the current stance with the FDA?

Lee Buckler said...

See my July 2012 post FDA 1. RSI 0. Regenerative Sciences (Regenexx) vs FDA (2012

Axel Wirthmann said...

To all:

I recommend reading the Nature Article "FDA's claims over stem cells upheld" by David Cyranoski, Nature, Vol 488,2 Aug 2012, p14

Axel Wirthmann