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Author Topic: Regenexx injections - Stem Cells  (Read 229061 times)

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Offline mayme

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Re: Regenexx injections - Stem Cells
« Reply #15 on: September 13, 2008, 11:05:51 PM »
Hi Guys,

I think this is excellent news that the FDA is investigating Regennex. If there are irregularities and improprieties, let's bring them into the bright light of day asap.

I'm glad to know that the FDA is closely scrutinizing Regennex--it protects and benefits us all. Now, let's see how Regennex handles this matter.

Offline 60schld

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Re: Regenexx injections - Stem Cells
« Reply #16 on: September 13, 2008, 11:36:00 PM »
Hi to all! :D ;D  I just got through re-reading the FDA letter.  Did anyone check the name of the
sender-Mary Malarkey!!!  Is that for real?  What a coincidence!! ??? ::) ;D ;D



TKR  finally done!!!  9/9/13     Whew!!

Offline mccartjt

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Re: Regenexx injections - Stem Cells
« Reply #17 on: September 14, 2008, 01:42:57 AM »
I spoke to my USC affiliated surgeon in Los Angeles on Monday about stem cell therapy.  Osiris & the University of Southern California USC have been doing clinical trials with mesenchymal stem cells.

http://www.osiristx.com/clinical_trials.php

& they have had fast track clearance to their end. See the following headlines from  their own website.

"FDA Fast-Track clearance expedites stem cell therapy"

"Osiris is also evaluating Chondrogen, an injectable formulation of mesenchymal stem cells, for arthritis in the knee. "

From my understanding Osiris wants to create a one shoe fits all approach. I.E. Make one batch of mesenchymal  stem cells and package it to everyone. Dr Centeno just cultivates your own stem cells, & puts them back into the body they came from.

I know a lot of people have great faith in the US Federal government & that its institutions like the FDA always err on the side of caution, but have any of you good folks noticed the financial mess that the USA is currently suffering from?

The FDA IMHO is far from perfect no matter how well intentioned!  Most people on this newsgroup will be familiar that Matrix Autologus Chrondrocyte Implant (MACI) procedure is available in Australia UK Germany Spain to name but a few countries. The FDA has yet to allow Genzyme to go ahead with MACI distribution here in the USA. Like I said I don't think that the FDA is perfect

FWIW, my surgeon is happy to let me try this procedure out, & aside from the risk of getting someone else's cells into my knee, he doesn't see the down side risk as huge. I have scheduled my appointment with Dr Centeno.


Offline 60schld

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Re: Regenexx injections - Stem Cells
« Reply #18 on: September 14, 2008, 01:54:49 AM »
Hi mccartjt :D 
               Please don't forget your KG pals.  Be sure to keep us posted about your procedure.
 8) :)!  I wish you every success 8) :D!!
               
TKR  finally done!!!  9/9/13     Whew!!

Offline plantgeek58

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Re: Regenexx injections - Stem Cells
« Reply #19 on: September 14, 2008, 04:17:32 PM »
Mccartjt,
I will agree with you that the FDA isn't perfect. I don't think any government agency is. But I have come to understand that they do a much better job of protecting us than most people realize. I would rather have an agency that is a little too cautious than one that is too quick to jump on the bandwagon of every new product out there. And as you just pointed out with the Osiris stem cells, when they do feel that a new drug or treatment is worthy, they will go ahead and fast-track it.

Do you know the reasons that MACI is being held back? Perhaps there are some valid concerns with the procedure. Having done extensive research myself on ACI, I found out that there are a lot of complications that can arise with the procedure, the most common being graft overgrowth. Approximately half of the patients undergoing the treatment have to have further surgery to correct problems with it. Also, the cartilage that forms isn't always hyaline, but more often results in a mixture of that and fibrocartilage, resulting in a less strong graft. There may be something similar going on with MACI.

With all of its problems, the US still has the best standard of medical care in the world and this is due in large part to the strict standards and controls to which physicians and researchers are held. Other countries are able to bring products and treatments to market sooner because they don't have these controls, but that isn't always a good thing. Sometimes patients pay the price for the lack of safety and efficacy studies. Do you recall the Thalidomide tragedy of the 1950's? It resulted in thousands of deformed babies in Great Britain. The US was largely spared, because our public health director wouldn't allow the product to be marketed here. She wanted more safety studies. As a result, the only cases over here were those whose doctors obtained it on the black market.

My biggest concern with Dr Centeno is that he isn't going through the proper channels to get his product certified. Therefore, we really don't know what the drawbacks may be. Even if the product consists of cells taken from your own body, they still have to be cultivated in media containing all kinds of nutrients and chemicals. That alone poses a slight risk of allergic reaction or contamination by foreign matter. And how do we know that the injected cells are actually forming hyaline cartilage? Have Dr. Centeno's patients undergone any followup studies to evaluate this? Have there been any instances of the cells growing where they shouldn't or growing uncontrollably? These are just a few of the questions that clinical trials could help to answer.

I'm not saying that this product may not work. I sincerely hope that it does, for all our sakes. But I seriously question Dr. Centeno's judgment. Osiris is going about things the right way and has been rewarded by beiing fast-tracked. Why doesn't Dr. Centeno want to do things properly? He isn't doing the majority of patients any favors by not seeking approval. Until he does, this product will only be available to those who are able to afford it, which means poor or middle-class patients may be out of luck.

OK, I'm getting down off my soapbox now. I wish you luck with the treatment and will look forward to hearing how you progress.
Terre 
RK 7/04 part. m. menisc., plica resect., MF
    3/05 part. m. menisc., open OATS
    1/07 part l. menisc., MF, patellar chondroplasty
    9/08 MF
LK 11/04 & 8/06 part m. menisc.
     7/07 LR, patellar tendon debrid., part m. menisc.

Offline mccartjt

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Re: Regenexx injections - Stem Cells
« Reply #20 on: September 14, 2008, 11:50:21 PM »
Terre

Thanks for your spirited thoughts. I am not so  sure that US medical care is the best in the world. That can only be decided on a case by case basis. Orsiris stem cells are stem cells, just not your own.

I am not going to debate MACI procedures that is outside the realm of this particular blog.

Here's a thought for you, what if Dr Centeno's procedures do in fact have permission, and that Mary Marlarkey assumptions are incorrect with her interpretation of the law, FDA and other factual stuff?

Dr Centeno is probably practicing medicine as he feels his doctorate allows him. As for the cultivation of stem cells that is done with your own blood, so no outside risk of allergenic reaction. Naturally enough if the result is positive in that the procedures do in fact regrow hyaline cartilige, (which can actually be measured on a Testla 3.0 MRI machine) would you want your knee sliced open to check that 's it hyaline cartilige? I don't think so. If my result comes out well, trust me I won't be allowing any digging into my knee anytime soon. 

You can read papers co-written by Dr Centeno here, http://tinyurl.com/6483a2

You can read papers co-written by Dr Wakatani  here http://tinyurl.com/5qebjm  &

http://tinyurl.com/566tns

Your assumption as to why Dr. Centeno might "want to do things properly?" may well  be ill founded. I suspect that your assumptions are based on the "Online lynching trial" of Dr Centeno's clinic via a letter posted on the FDA's website. Factually that is what that FDA open letter to Dr Centeno's clinic is an "Online lynching"

Fact is stem cells have been shown in the papers published above  that " hyaline-like type of cartilage tissue " has been regrown from stem cells. So is the procedure bullet proof? No. Is there risk? Yes.  From the people I've seen online on this URL

http://www.youtube.com/results?search_query=regenexx&search_type=&aq=-1&oq=

 they seem healthy to me.

Offline mayme

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Re: Regenexx injections - Stem Cells
« Reply #21 on: September 15, 2008, 12:44:33 AM »
Dear Terre & Mccartjt,

Please keep posting. Both of you seem highly informed & insightful. The more we debate this -- the more knowledgable we become -- and then we all win.

Terre, I did question one of your comments re: MACI v. ACI. You pointed out that maybe MACI is not FDA approved in this country since it might have some of the same complications as ACI -- and you pointed out some very valid & serious drawbacks with the ACI procedure.

Yet the ACI procedure has received FDA approval & is practiced daily in this country.

I believe I understand the point you're trying to make but even with all the clinical trials & even with FDA approval, drugs are pulled off the market because of serious & even fatal unexpected side effects.

Of course we don't want to open the floodgates & willy-nilly approve all drugs & procedures but it's certainly not a perfect system.

Please keep posting and thank you both for taking the time to iinform us all!

Offline mccartjt

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Re: Regenexx injections - Stem Cells
« Reply #22 on: September 15, 2008, 03:21:28 AM »
Mayme

There are drawbacks to every procedure, MACI /ACI / Injections. However, my surgeon who is a teaching orthopaedist at USC and other clinics, has been following the Osiris procedures with USC Keck School of Medicine. My own stem cells he's okay with, Osiris's stem cells are another ball of wax.

I am getting the procedure done on me, so I've been researching this step as thoroughly as possible, it is my body after all.  I had seen the open lynching of Dr Centeno 's clinic via the FDA letter before it was mentioned on this blog. I  have no problem that someone with too much time on their hands @ the FDA were in fact speaking beyond their legal  limitations. 

As for if this procedure will or not get FDA approval is moot. If you'd pay money for a house why not pay for your health? The world is full of people that have paid for plastic surgery, why not pay for orthopaedic injections too? This procedure is similiarly expensive as breast augmentation in Beverly Hills,  so I have a good chance at fixing my knee for the same sort of money.

 Life is about the quality of life. I have friends who have homes on the Cote d' Azur & the quality of life that goes with their choices, this one is mine for the quality of my life..

I'll keep you posted as to how it goes.

Offline mccartjt

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Re: Regenexx injections - Stem Cells
« Reply #23 on: September 15, 2008, 03:33:39 AM »
Mayme

One more thing, this last peer reviewed paper

http://tinyurl.com/5n4mvc

Published on September 9th 2008 was

Co-authored by Dr Centeno, & (among other doctors,) Dr David Karli of the Steadman-Hawkins clinic of Vail, Colorado.

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

Offline plantgeek58

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Re: Regenexx injections - Stem Cells
« Reply #24 on: September 15, 2008, 02:28:11 PM »
"Open lynching?!" That is nothing more than a cheap shot, Mccartjt. All FDA transactions have to be made open to the public, which is why this letter appeared on their website. And if you read it closely, you may recognize that it's purpose is to inform Dr. Centeno that he is in violation of several of their regulations and to request compliance. As I stated before, his product is classified as a new drug and is subject to FDA regulation. He does NOT have permission to bring this product to market, because he has not filed an Investigational New Drug Application nor does he have a valid Biologics License on file with them. He does not have the right to practice medicine this way, doctorate or not. All researchers are subject to the same regulations and he is in violation of the law. The letter does warn him of legal consequences, and if you seriously think that the agency is overstepping its bounds in this regard, you are 100% wrong. FDA regulations concerning biologics carry the full weight of law behind them. If the agency thinks that the violations are serious enough or if Dr. Centeno refuses to comply, they DO have the legal authority to force the shutdown of his operation. Ms. Malarkey is not overstepping her legal limits in warning him of the consequences of noncompliance. BTW, nice comment about her. Way to belittle someone about whom you know absolutely nothing. I can assure you that people who work for the CBER do NOT sit around looking for ways to make trouble for innocent people.

I'm glad you have the kind of money to be able to spend on a procedure like this, but my point was that there are a lot of people out there who struggle just to keep themselves and their families sheltered and fed, let alone having to pay for medical care. Not everyone in this country can afford to buy a house and not everyone is going to be able to afford this procedure. It's going to remain the purview of those who have money to spare unless it becomes FDA approved and is picked up by insurance companies.

As for the cells being cultivated in your own blood alone, that also is not true. It takes a lot more than just blood to get cells, even mesenchymal stem cells, to grow in a lab environment. It isn't as easy as you think. I know this from experience, having had to grow bacterial, yeast and mammalian cells in my lab classes. The nutrients and chemicals that normally would be replenished regularly by the body must be supplied to the media in the lab. A typical growth medium may contain more than 20 elements, not all of which are the same as that which is found in the body. So yes, there is a risk, albeit extremely small, of allergic reaction. There is also the risk that an undetected cancer cell may be harvested and propagated along with the healthy cells. Again, the risk is very small and as you say, there are risks with every procedure.

Mayme, point taken about the drugs that get pulled from the market because of unexpected side effects. I suppose I should have said that 'most of the time' there are no surprises. Given the thousands of new drugs that come out every year, though, such instances are relatively rare. There would be many more if we didn't have the safeguards that we do.

OK gang, this is probably going to be my last post on the subject. I've made my points as succinctly as I can and I refuse to take part in a pot shot session, which seems to be the direction in which the discussion is headed. I apologize if I've offended anyone and wish you all well.
Terre
RK 7/04 part. m. menisc., plica resect., MF
    3/05 part. m. menisc., open OATS
    1/07 part l. menisc., MF, patellar chondroplasty
    9/08 MF
LK 11/04 & 8/06 part m. menisc.
     7/07 LR, patellar tendon debrid., part m. menisc.

Offline mayme

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Re: Regenexx injections - Stem Cells
« Reply #25 on: September 15, 2008, 03:38:41 PM »
Terre,

Don't you dare stop posting! The information you are sharing with everyone is invaluable. I know you and Mccartjt both feel strongly about your positions and that's what makes this site awesome.

I'm thrilled you brought the FDA letter to our attention & I'm thrilled Mccartjt brought articles about Regennex to our attention. Knowledge is power and you two are helping us all. I think I'm like most people on this site; we want to learn as much as we can about any procedure we're considering and that includes the good, the bad and the ugly!

I've learned more about Regennex & how the FDA regards this new procedure in the past few posts than I've been able to learn in the past six months--compliments of you two!

You can tell by the number of "hits" on this blog that lots of people are paying attention.

Don't leave us girl! Stay on here & keep punching! We need you both!

Many thanks.

Offline mccartjt

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Re: Regenexx injections - Stem Cells
« Reply #26 on: September 16, 2008, 03:19:07 PM »
Terre

Thanks for your posting.

I feel that you may have missed one of the most important parts of that letter posted by the FDA.  That it is FDA's position / (mis-) interpretation of the law that says that Dr Centeno has created a new drug. What if Dr Centeno attorneys disagree with that position and actually has the law on his side? Then he's just practicing medicine, might that not be the case?

Your assumption of guilt (with out trial) of Dr Centeno & his clinic's practices goes against all of the "Jurisprudence" that America holds dear to its proverbial heart. To quote your letter here "All researchers are subject to the same regulations and he is in violation of the law." Well  what then if Dr Centeno is not in breach of the law? Does he get redress?  Then the original posting on the FDA's  website could well be perceived as an "Open lynching"

Please don't begrudge me the chance to repair my knee, because I can afford to pay for it. That is truly  & totally unfair. In fact as  much as I don't want to pay for it out of my own pocket & actually have  my insurance pay for this, is that they  currently won't pay. Two years from now maybe this procedure might be available from insurance companies with the full blessing of the FDA.

In fact all the on going research with Dr Centeno's procedures will add to the body of knowledge for the future of medicine, as shown by his postings on the National  Library of Medicine. What if Dr Centeno's struggles actually help millions of people fix their bad joints are you against that too? Or would you not stand to benefit from it in the long  run. Don't forget in the greater scheme of things the cost of the Renenexx procedures is way way cheaper than debridement/Arthroscopy / MACI /  ACI operations. Insurance companies would jump at the chance of a cheaper solution than TKR.

One thing I can say confidently is that Ms. Malarkey may be overstepping her position (unless of course you are in fact Ms Marlarkey). Time will tell how this whole story unfolds.

Terre I wish you all the best.

Offline plantgeek58

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Re: Regenexx injections - Stem Cells
« Reply #27 on: September 16, 2008, 04:58:59 PM »
Mccartjt,
I don't begrudge you the choice of treatment for your own knee. That decision is yours and yours alone.

However, Dr. Centeno absolutely does not have the law on his side, no matter what his lawyers may argue. This product is cell-culture based and its clearly stated purpose is to treat human disease. Therefore it unequivocally comes under FDA regulation as a new biologic drug. Your statement that the agency is interpreting the law is mistaken. The FDA has been granted authority by the US courts to CREATE the laws governing biologics. The regulations are very clear and are NOT open to interpretation. They ARE the law. Compliance is mandatory.

There is nothing in the FDA letter that could be perceived as a 'lynching'. It is a simple notification. It does not attack Dr. Centeno's character, nor does it denigrate his product. It states the violations and requests compliance, AS PER THE LAW.

I have nothing against this procedure or the valuable research Dr. Centeno is doing. It may well be a valid and less invasive treatment option for tissue damage. My objections are the methods by which this physician is going about the testing and marketing of the product.

Finally, as I've stated before, insurance companies are not going to back any treatment that does not have the FDA stamp of approval, no matter how effective it appears to be. It will simply continue to be considered experimental and coverage will be denied. Furthermore, actual long term success/failure rates for the treatment have yet to be established and this is another factor that insurance companies take into consideration. If the treatment turns out to not offer lasting benefits, or if its success rate is relatively low, then it still won't be picked up by the companies in preference to TKRs, which have a success rate of approximately 90%. Insurance companies tend to prefer a sure thing over a treatment that may or may not work. 

Terre

RK 7/04 part. m. menisc., plica resect., MF
    3/05 part. m. menisc., open OATS
    1/07 part l. menisc., MF, patellar chondroplasty
    9/08 MF
LK 11/04 & 8/06 part m. menisc.
     7/07 LR, patellar tendon debrid., part m. menisc.

Offline 60schld

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Re: Regenexx injections - Stem Cells
« Reply #28 on: September 17, 2008, 01:21:06 AM »
 Hi out there :D :D  Wow this discussion is fantastic!!  I agree with mayme, I have learned more
from this post since you guys are sharing some truly valuable info and opinions :D 8).
Keep it coming!!  8) :D  thanks-  60schld
TKR  finally done!!!  9/9/13     Whew!!

Offline mccartjt

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Re: Regenexx injections - Stem Cells
« Reply #29 on: September 17, 2008, 03:59:32 AM »
Terre

Please tell me what ever happened to due process? What ever happened to being innocent before proven guilty? The FDA / the US Government has laws in place. Typically it is a court that decides in matters of the law, not you (unless you are a judge)  nor I.


 Since I am not a FDA attorney assigned to this case, nor the attorney for Dr Centeno I won't debate these points with you. It is suffice to say that there are plenty of attorneys in the USA that can do all the jaw boning needed in any interesting case. I do know from experience that there can be interpretation of the law, which is why one employs an attorney & that these folks usually meet in a court of law. It is in this area that your assumptions about Dr Centeno's procedures maybe incorrect. I will agree with you too on one point that compliance of the law is mandatory. I am confident whatever the law is it will come out in the fullness of time, you can sleep soundly on knowing that.


Your assumptions that insurance companies won't embrace Dr Centeno's procedures may well be unfounded too. Do you currently know the success ratios that Dr Centeno's procedures are experiencing?  & the alternative Osiris procedure of their MSC's has only a 30% success ratio in the phase 1 & II trials.

One of my real issues is with the FDA is that I've been waiting for 3-4 years for them to make its mind up about MACI here in the USA & they have yet to get off the fence. If I lived in the UK I'd be back to health by now..

 Dr Joe Maroon gave Dr Centeno a glowing reference with him back to running 13 miles, then cycling 75 miles & swimming over a mile  all in one day and qualifying for the Hawaii Ironman too boot! Whilst two other orthopaedists offered Dr Maroon only a TKR with its miserable quality of life issues. As for how Dr Centeno goes about his business of helping patients be thankful that people are saying extremely good things about his procedures.

Finally if you want a sure bet in life count on paying taxes and dying.















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