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Author Topic: Regenexx injections - Stem Cells  (Read 223808 times)

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Offline Dr. Centeno

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Re: Regenexx injections - Stem Cells
« Reply #135 on: April 07, 2009, 08:46:33 PM »
Dear all,

I only check this discussion board periodically, so I was surprised when I happened upon "abbaroodle" who has been "lurking" for awhile, but who only registered four days before his post.  Let me answer his "worries" one by one:

1.  We performed two years of "free" research before we ever decided to see the first commercial patient.  My partner and I spent hundreds of thousands of dollars treating these patients for free, establishing a lab, paying for MRI's, etc...  This went through an HHS registered IRB.  This IRB had various physicians, physical therapists, and community members.  Their job was to review studiy designs so that patients were protected.  I no more control this group of people than I control any other group of people.  I was not able to vote on any project in which I was involved.  In fact, they required that we start slowly, only approved a handful of patients, etc...  Their approach was to allow us to crawl, then walk, then jog.  Again, this process of going back and forth to the IRB took two years without a single subject paying for care, in fact it continues in some applications to this day.

2.  As I have said, the FDA has no authority over the practice of medicine.  A better summary of the issues is located at http://www.regenexx.com/2009/03/adult-stem-cells-now/.  It's interesting to note that the same day abbaroodle registered is the day that this Regenexx blog post went out. 

3.  The FDA process ensures patient safety?  Give me a break.  Celebrex, Vioxx, Plavix, Zyprexia, Paxil, Heparin.  This is a very short list of instances where the public was absolutely not protected by the FDA process. 

4.  The Regenexx procedure has a growing list of things that can be "cured".  This is absurd.  We treat joints.  These have always worked well for us and detailed descriptions of MRI results are discussed at http://www.regenexx.com/about-regenexx/regenexx-blog/.  We have also treated ligaments/tendons and non-healing fractures.  We tried lumbar discs early on, but had poor success, so we waited some three years before treating any commercial patients.  The story on this development is located at http://www.regenexx.com/2009/02/stem-cells-and-disc-repair/.  While this now works well, it demonstrates that we don't release an application to paying patients until we're convinced it can help some people. 

Like any medical procedure, Regenexx may or may not work for any individual.  As a result, the patients on this board will attest to the fact that we go through great lengths to categorize patients into GOOD, FAIR, or POOR candidates fro what we do.  We only tell about 20-30% of the patients whose knee MRI's we review that they are GOOD candidates.

5.  We are "pushing" an untested therapy.  As you all know, the research showing that arthroscopy is effective for knee pain has come under some fire, for more details see http://www.regenexx.com/2008/09/arthroscopic-knee-surgery-alternative/.   The research shows it's not effective.  What are these knee patients supposed to do?  Sign up for a life changing knee replacement?  Patients have choices in 2009, some will choose to get knee replacements and some will choose other things such as ACI, micro fracture, MACI, SynVisc, the Regenexx procedure, etc...  The surgical procedures on this list have gone through no FDA approval process, yet are performed every day. 

Why this post from abbaroodle? 

What the cell therapy industry desperately wants is your adult stem cells to be classified as a drug.  While this makes no sense from a medical and safety standpoint, it really helps the big pharma business model.  A group of physicians have come together to oppose the FDA's position on this issue, see www.stemcelldocs.org.  Patients have also come together to oppose the FDA's position on adult stem cells, see www.safestemcells.org.  Any of you who don't want the FDA and big pharma to make drugs out of the cells in your body, the Safe Stem Cells site is a great place to gain some perspective of what's at stake.  The stories that patients with terminal diseases have posted there can give you a quick jolt of reality as many of these patients will likely perish before the FDA and big pharma get around to figuring out how to commercialize adult stem cells as a drug (see http://safestemcells.org/Patient_Voices.html).  While we don't treat these things (we're strictly ortho), other doctors will be opening stem cell labs to help these people. 

Offline BearsCubs

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Re: Regenexx injections - Stem Cells
« Reply #136 on: April 07, 2009, 09:04:34 PM »
There's a common label for people like "abbaroodle" that I'm sure we've all heard - for sure if you visit any sports team's fan message board:  TROLL.

I've had the Regenexx procedure on my knee and would do it again in a heartbeat.

I encourage anyone interested in having your voice heard regarding battling the FDA and big Pharma to register at the patient web site Dr. Centeno gave, www.safestemcells.org.

Offline mccartjt

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Re: Regenexx injections - Stem Cells
« Reply #137 on: April 08, 2009, 05:12:09 AM »
BearsCubs

I've signed up already. I have also noticed that Dr Centeno has published a great deal of his clinical work recently on his own website. If you suffer from a multitude of ortho conditions I am sure we can all learn something from his published experiences.

JM

Offline thevoice

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Re: Regenexx injections - Stem Cells
« Reply #138 on: April 10, 2009, 10:37:52 AM »
whats the next step in stem cell treatments - do they need to be held in 3d scaffolds for better healing to the injured area?

Dr. Centeno do you foresee a court battle with the FDA and if so whats chances of winning...I totally agree with you about it should be allowed to be used saftely and freely as stem cells our our own bodies and not drugs.

Offline sugarbranch

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Re: Regenexx injections - Stem Cells
« Reply #139 on: April 21, 2009, 11:51:55 AM »
I am sending a copy of my MRI and after surgery notes to Denver with my fee for my evaluation.  I had my 3rd surgery on Jan 13 09 and they did remove debris in my right knee but was not really much relief.  I am 49 F  and almost wheel chair bound with severe  muscle waste in my right leg. I have been very active with horses all my life.  I am told that I am not old enough for a tikr but really do not want one anyways.  I am going to give this a try if they accept me.  I could care less if it is FDA approved or not as I do not feel that they give 2 hoots about my health and well being but if they can fill me full of meds that I would have to take daily that have severe short and long term effects that cost lots of money, that in turn make me need more meds that have bad effects and cost more money....I do not trust the FDA and feel safer knowing this is not connected to them.  I will post after I know what is going on and if accepted, the results.  I will do just about anything to return to normal.  I want my active life back and dream of being able to ride and care for my horses again.  I would also like to be able to go dancing & 2 stepping again.  Actually, it would be nice to just be able to walk without severe pain.  I have bone on bone throughout most of my knee and a bakers cyst.  It is ruining my life.  My thoughts are FDA bad   DENVER   GOOD!!!

Offline GJJ

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Re: Regenexx injections - Stem Cells
« Reply #140 on: April 21, 2009, 08:31:00 PM »
You go for it!

Surgeries do no good and FDA does needs to go after the real crooks and stop pretending to care for real people.

Keep us posted.

I am still waiting to hear from state.

Good Luck!
Don't give up.

abbaroodle

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Re: Regenexx injections - Stem Cells
« Reply #141 on: April 24, 2009, 03:43:28 AM »
Hi guys,

Wow, guess this isnt a group that likes to discuss subjects that dont have an easy answer! I forgot that the definition of a troll is anyone who disagrees with you.   ::)

I really dont want to go through and argue points one by one.  Its up to you as a potential patient to decide whether or not regenexx or any other procedure or treatment is right for you.  Just know that there are risks out there.  And there is no guarantee it will work.  (And you are right.  There is no guarantee surgery will work either!) 

Just a few thoughts on stem cell therapy in general.  This is not specific to Dr. Centeno or regenexx since you all clearly have done way more research about him than I have.  This is simply my own thoughts for any patient considering any stem cell therapy.

The International Society for Stem Cell Research (ISSCR) (http://www.isscr.org/clinical_trans/index.cfm) has put out a handbook that has some really good guidelines about what to look for in a clinic and a stem-cell treatment. http://www.isscr.org/clinical_trans/pdfs/ISSCRPatientHandbook.pdf  For example, they feel it is necessary to have pre-clinical animal-based trials to ensure there are no longer-term problems like tumor growth, and patients need longterm monitoring to ensure limited risk to them. Also, ensure that your cells will be used for no other purposes, either clinical or research, without your explicit permision in the future.  Finally, ask about who will cover costs for emergency treatment just in case something goes wrong. 

Who knows.  Maybe the ISSCR is really just a lobby-group run by FDA and some big pharma to try to shut Dr. Centeno's clinic down.

Here is a link to a very, very well respected journal.  (One of the most-frequently read journals among scientists.)  They have published many articles on stem cells.  I will let you read it for yourself.  But note a few highlights below.

http://blogs.nature.com/reports/theniche/2008/03/patients_paying_for_stem_cells.html

"At a press conference in Half Moon Bay, California, a panel of highly influential officials and researchers in stem cell science said they were alarmed at “medical tourism” in pursuit of questionable and potentially harmful stem cell procedures. The only established stem-cell treatments are for a handful of blood diseases, they said, but advertisers promise cures for every imaginable disease."

"“It’s clear from those letters that there’s desperation with a complete lack of sophistication” in the ability to assess procedures, said Landis, head of the NIH Stem Cell Task Force. “Without that people will do things that are not in their own best interest.” Patients don’t know (or necessarily care) about established standards for clinical research, particularly that patients are rarely asked to pay for experimental procedures, and that they must be adequately informed of potential risks and benefits and the questions a trial will answer." 

"Patient desperation is “an invitation for exploitation,” said Daley, president of ISSCR and an associate professor at Harvard University, adding that one has to be very suspicious when asked to pay thousands of dollars to pay for treatments thousands of miles away. Patients should be asking questions such as whether researchers are affiliated with established medical centers and have published in scientific journals."

Here is another nature article.  It focuses more on international stem cell treatment, but I think it hit some good points. 

http://www.nature.com/stemcells/2008/0812/081211/full/stemcells.2008.157.html

"The society condemned stem cell tourism, saying that shady clinics exploit patients' hopes and could jeopardize "legitimate progress of translational stem cell research."1 Researchers worry clinics promote unreasonable expectations for how quickly mainstream work will progress and generate bad publicity that could tarnish the entire field."

In many cases, claims are unrealistic.  "Caulfield and colleagues described the claims as "optimistic" and "unsubstantiated by the peer-reviewed literature." Benefits of treatment were overemphasized and risks were underemphasized."

"Sometimes, "clinicians may be justified in attempting medically innovative stem-cell based interventions in a small number of their seriously ill patients," but in such cases, they should be moving toward a clinical trial." 

Before you decide to try something new, try to keep an open mind and educate yourself as much as possible from both the supporters and those against a new treatment. Then make your own, more informed decision.

Happy healing!  I am totally jealous of everyone who is out running and biking in this gorgeous weather!!!

Offline mccartjt

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Re: Regenexx injections - Stem Cells
« Reply #142 on: April 26, 2009, 10:14:46 PM »
Abbaroodle

As for the peer reviewed clinical studies of whether MSC's work & create cartilage
http://tinyurl.com/5qebjmhttp://tinyurl.com/566tns & http://tinyurl.com/6483a2  should suffice anyone's curiosity.

As I am replying to only your second post on this blog, (& I have read both), you've yet to mention exactly what condition you are suffering from.  So what is the real reason for posting here?

Offline celltherapy

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Re: Regenexx injections - Stem Cells
« Reply #143 on: April 30, 2009, 04:51:55 PM »
I have removed my previous posts from this board. To see my take on Regenexx see http://www.celltherapyblog.com

--Lee
« Last Edit: April 30, 2009, 09:08:46 PM by celltherapy »

Offline blues

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Re: Regenexx injections - Stem Cells
« Reply #144 on: May 07, 2009, 05:34:16 PM »
Hi Folks,

I found this forum after doing some online research about stem cells and knees.

I am a 53 year old male, had a basketball injury to my right knee when I was 19. The torn lateral meniscus was removed and I continued on with life, like everyone else in those days, with a knee that has always given me trouble. 3 arthroscopic surgeries (1979, 1986, 2002) later to "clean it up" have done nothing but leave me with an arthritic knee which greatly diminishes my quality of life. I can't walk or stand for long periods, climb stairs or ladders without pain and difficulty. As a sports/travel photographer, I get a lot of "snap, crackle, pop" when getting in position to take photos. Exercise has never been able to build my quads to the point that my knee feels stable. This story is probably repeated on this board many times a day.

I love to play golf, but have been reduced to only playing a few times a year, mostly because it takes weeks to recover from the inflammation. I just have gotten to the point of "its not worth the pain" to play any more.

I recently (I think) sprained my MCL, which caused a re-thinking of this old, tired knee thing and I have started looking into a replacement. Of course, as a long-time knee problem sufferer, my insurance excludes anything regarding that knee, so I have to pay for  any treatment out of my pocket.

I have had a physical therapist look at my films over the years and he encouraged me to start looking into stem cell work on knees, his logic being, once you go down that TKR road, there is no going back. So here I am, having gone to Dr. Centeno's website and filled out the prelim form to start the consultation process.

I have learned a lot in the past few hours of reading here, and thank all of you for your input. I live in Texas, so a quicky flight to Denver is no big deal for me. My eyes are wide open and I've drunk the Kool-Aid.

I'll let y'all know how it goes, if I even qualify, etc.

Cheers,
Joe

« Last Edit: May 07, 2009, 05:38:38 PM by blues »

Offline kripple

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Re: Regenexx injections - Stem Cells
« Reply #145 on: May 20, 2009, 09:59:33 PM »

The procedure, which costs $5,000 to $7,000, is not covered by insurance. Maroon knows of no one in the Pittsburgh area doing similar work.


Interesting.  So the procedure costs between $5,000 to $7,000 for me to receive two injections into my knee.  That sounds perfectly reasonable. 

Offline mccartjt

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Re: Regenexx injections - Stem Cells
« Reply #146 on: May 22, 2009, 04:36:27 PM »
Hello Kripple

We thank you for your sarcastic posting. Clearly this being your very first post on this particular blog its probably safe to suggest that you might be an Internet Troll.

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

In Internet slang, a troll is someone who posts controversial, inflammatory, irrelevant or off-topic messages in an online community, such as an online discussion forum or chat room, with the primary intent of provoking other users into an emotional response[1] or to generally disrupt normal on-topic discussion.[2]

« Last Edit: May 23, 2009, 03:33:28 AM by mccartjt »

Offline mccartjt

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Re: Regenexx injections - Stem Cells
« Reply #147 on: May 22, 2009, 04:46:55 PM »
In the interests of folks who 's knees maybe in bad shape, I know of one person that has just recently had a double TKR performed on both his knees..  See URL below,

http://tinyurl.com/pmnlch

I posed him the question below

"Having had your both your knees, TKR'd, if you could do your knee procedure all over again would you have opted (now knowing what you do) for stem cells for your knees as a first alternative to TKR?"

Mccartjt, I believe this was faster route.(TKR)
Now, knowing the degree of pain that I went through from the operation and therapy and still are going through now. I would have done the Adult stem cell injections. The pain is severe. On a scale of 1 to 10 the first two weeks were close to 9.5 most of the time. If I only had one done I would not have dad the other one done. "


Indeed an important lesson for people with bad knees! Avoid the TKR if at all possible!!

Happy Memorial day weekend to all...

JM


« Last Edit: May 22, 2009, 08:45:55 PM by mccartjt »

Online 60schld

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Re: Regenexx injections - Stem Cells
« Reply #148 on: May 23, 2009, 12:45:26 AM »
To Kripple,  I follow this discussion closely, and while I admit the procedure is not cheap, there is a lot more involved than just 2 shots!  There is prep, growing stem cells etc.  I would think you would know that if you really followed this forum.  However, I find everyone's opinions worthy.  In the end,the simple fact of success rate will prevail.... discussions or not!  Happy Memorial Day weekend 8)
TKR  finally done!!!  9/9/13     Whew!!

Offline kripple

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Re: Regenexx injections - Stem Cells
« Reply #149 on: May 24, 2009, 05:08:15 AM »
Hello Kripple

We thank you for your sarcastic posting. Clearly this being your very first post on this particular blog its probably safe to suggest that you might be an Internet Troll.

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

In Internet slang, a troll is someone who posts controversial, inflammatory, irrelevant or off-topic messages in an online community, such as an online discussion forum or chat room, with the primary intent of provoking other users into an emotional response[1] or to generally disrupt normal on-topic discussion.[2]




Or perhaps it's my first post because that's generally where one begins when they join a board?  Logic is your friend.  Use it every now and then and things will make much more sense to you.















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