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Author Topic: Regenexx injections - Stem Cells  (Read 207972 times)

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Offline BearsCubs

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Re: Regenexx injections - Stem Cells
« Reply #120 on: March 01, 2009, 02:16:38 PM »
Dr. Centeno,

Since I had both procedures performed (mf and cells, albeit roughly 7 weeks apart) I'll be VERY interested to hear the results of that study.

Take care.

Offline Dave1

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Re: Regenexx injections - Stem Cells
« Reply #121 on: March 04, 2009, 10:46:20 AM »
Hi All,

I am new here but NOT new to cartilage pain. 

I have a 15 x 10mm cartilage defect in my left ankle with a subchondral cyst.  The rest of my cartilage is well preserved.   My ankle just now is pretty stable however I cannot play any sport.  I will be in Europe in April and was looking at stem cell implantation from the German company ‘X – Cell’. 

I have a question for Dr Centeno.  The main difference between Xcell and Regennex is that X cell  offer only one injection where as Regenex grow the cells into large numbers then do a 2nd or even 3rd injection two to three weeks later.

X cell comment that by growing the cells you offer the chance of side effects in the future and say they would NOT consider doing this. I would welcome Dr Centeno’s comments on the single injection procedure offered by X Cell.

I am looking at Stem cell  as alternative to MACI surgery.  The MACI  procedure involves taking a 'spec' of healthy cartilage from your knee, growing  the cartilage in then lab, then implanting the grown cartilage into the defect.  This involves breaking the ankle and involves a year's recovery.

Hope to hear from you,
Dave

Offline BearsCubs

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Re: Regenexx injections - Stem Cells
« Reply #122 on: March 04, 2009, 10:33:05 PM »
Dave,

I'm sure Dr. Centeno will give the more complete technical rundown, but from someone who's had Regenexx I really don't think there's too many side effects to worry about. At least none that I have personally experienced since they are your own cells going back in.

Offline mccartjt

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Re: Regenexx injections - Stem Cells
« Reply #123 on: March 05, 2009, 12:17:03 AM »
Dave

I am not familiar with a Subchondral cyst, however I've been thru the process of MACI versus Regenexx, & went with the Regenexx procedure for my knee for several reasons. First reason was cost, Regenexx is much easier on the wallet. Second reason was less invasive. Third reason MACI isn't [email protected] the moment in the USA & I am based in California so that made that decision easier to make,  as there's a lot more hassle getting MACI in Spain / Germany/ Switzerland than a few flights to Denver.. Fourth reason is rehab ~ an open knee procedure with MACI or ACI is horrendous with a 12 month rehab protocol!

On another note Dr Centeno discussed earlier in this thread his experience  with BMAC ( which I believe is is what X-Cell says they are doing)

See below,
"We used BMAC in 2005-2006 and even published one interesting case report.  See http://www.ncbi.nlm.nih.gov/pubmed/16886034?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum  The problem we experienced was that BMAC didn't have enough stem cells in it to help most patients. "

To X-Cells comment of the side effects of growing cells outside your body that are unknown, Osiris is basically doing (with the FDA's blessing) that at the moment with Allogenic stem cells in their stage I/II trials.  See  http://www.osiristx.com/clinical_trials_chondrogen.php  and are seeing success albeit not nearly as good as Dr Centeno is seeing.  See results here http://investor.osiris.com/releasedetail.cfm?ReleaseID=278696  (Allogenic being person neutral stem cells in their product offerings)

Also recently I noticed this on the web,  http://www.orthosupersite.com/view.asp?rID=37347 American Academy of Orthopaedic Surgeons (AAOS) have launched the The Biologic Orthopaedic Society (BOS)

From that website “BOS is a collaborative effort of several eminent scientists who recognize the immense potential of biologics to improve orthopedic care,” Randelli added in a statement. “We want to share what we have learned in our own labs, to compare results, collaborate on promising treatments and disseminate this important information to the orthopedic community at large.”

So the direction that AAOS and now the BOS are going in is in furthering what Dr Centeno has shown working.

As for my own knee's condition, its still improving and I am only 10 weeks into the recovery.

John M

Offline thevoice

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Re: Regenexx injections - Stem Cells
« Reply #124 on: March 05, 2009, 09:39:12 PM »
intresting stuff, where can we find more info out on the CSU stem cell study?

Offline thevoice

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Re: Regenexx injections - Stem Cells
« Reply #125 on: March 08, 2009, 09:35:03 AM »
A company in Austrialia called Mesoblast are currently trialing stem cell injections into the knee joint. In animals models 1 injection seemed to improve things for up to 1 year, there now doing studys in humans. I think they have quite high hopes for this and are hoping for a 2012 release all going well.

Does anyone know this method differs from Regenexx methods?

Offline Dr. Centeno

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Re: Regenexx injections - Stem Cells
« Reply #126 on: March 08, 2009, 04:31:44 PM »
Thanks to all for the kind words and the great discussions. 

ACI is what Genzyme does with Carticel.  They take cartilage cells, grow them to bigger numbers in their lab, and then send them back to the surgeon to implant.  To hold them in place, the surgeon must disect out a piece of the fibrous covering of the bone (periosteum) and then place the cells below that flap. The surgeon then sews the flap back down.  This adds allot of time to the procedure, so many surgeons would prefer micro fracture as it's much faster (but also more invasive). 

MACI was developed in Europe to try and make ACI easier.  In this procedure they take the cells and then place a pig based collagen membrane over the area.  The idea is that the collogen acts as a growth scaffold and produces better cartilage, as well as making the surgery less invasive (since you're not discecting out a flap of periosteum).  However, it's still a big and invasive knee surgery.

As far as growing cartilage cells, Genzyme has been doing that for a decade with it's Carticel product.  There is nothing dangerous about that process of culturing cells, but many scientists believe it can cause "hypertrophy" in cartilage cells, which means that they don't work as well.  There are several European companies who have been working on ways to produce less "hypertrophy" in growing these cells and thus improve the outcomes of ACI/MACI.

Once mesenchymal stem cell procedures become more common, they will likely replace all the cartilage transplant and cartilage cell culture procedures.  The reason is that cartilage cells were never built for repair, they are simply building blocks.  The analogy I give my patients is that cartilage cells are like bricks without the mason.  Since they are cells that are alive, they have some limited ability to rearrange and maintain themselves as well as produce their own mortar (called ECM), but they can't do much complex repair without a brick mason.  Dumping a ton of bricks on a construction site and forgetting to hire the mason won't get you far towards building a new brick house.  If you have special living bricks (cartilage), you may get a pile of bricks that can become a disorganized lump of bricks.  This is the reason why cartilage cells are so hard to get to work to repair holes in the cartilage.

Mesenchymal stem cells (MSC's) are like bringing in the bricks and hiring a mason to put them together.  They can differentiate into cartilage cells (bricks) and also have a brick mason function where they coordinate repair (things like bringing in new blood supply).  MSC's are primed for repair.  As a result, when compared head to head in animal studies, they always beat out transplanted cartilage cells when it comes to fixing a hole in the cartilage.

As far as growing cells and risks, I have a really detailed blog entry on this located at http://www.regenexx.com/2009/02/stem-cells-and-cancer-buyer-beware.  The bottom line is that limited culture expansion of a mesenchymal stem cell line has been well studied.  The research to date would suggest that this process poses negligible risks.  We have 400 patients now in our tracking database with no issues detected, with about 50 of those undergoing high field MRI surveillance of the MSC transplant site and a scientific publication on this topic that has been submitted for publication. 

In summary, MACI is an improvement over ACI.  However, at the end of the day, they are both big surgeries that place only the bricks at the construction site.  MSC's are like bringing the bricks and a mason to assemble them into a repair. 
« Last Edit: March 08, 2009, 08:14:42 PM by Dr. Centeno »

Offline thevoice

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Re: Regenexx injections - Stem Cells
« Reply #127 on: March 16, 2009, 10:16:15 PM »
thank you in depth info Dr. Centeno. When do you see stem cells being used mainstream for knee cart issues? how far off do you think we are in years?

Offline NikkiE

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Re: Regenexx injections - Stem Cells
« Reply #128 on: March 25, 2009, 10:03:47 PM »
Yes I'd like to know some kind of time frame too. Its starting to look like my next option will be surgery. If it's only estimated to be a few years til we're using stem cells then I will hang on.
Chondromalacia in right knee for 13 years. 

OA in medial section of right knee, almost bone on bone.

OA in medial section of left knee

Offline powerlifter

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Re: Regenexx injections - Stem Cells
« Reply #129 on: March 30, 2009, 02:12:05 AM »
This has been so informative. Thanks, Dr. Centeno.

I've been reading this board with horror. Surgery seems to hurt as many as it's helped. It comes off as a bunch of guesswork. It's like we're still doing medieval chop-work, just with much smaller tools. It seems we finally have a technology that really assists the healing process instead of just cutting parts up and doing makeshift patchwork.

My own problem can be managed with rest, ice, liniments, "vitamin I" and compression. I powerlift and can still practice the squat and deadlift with neoprene knee sleeves. Jumping and especially running are what set my plica off. I'm now hopeful that if I start saving now, I can afford this therapy and be able to run without fear of permanently crippling myself. I just hope the government doesn't muck things up and force me to have to travel outside the country to get treatment.

Offline mccartjt

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Re: Regenexx injections - Stem Cells
« Reply #130 on: April 02, 2009, 06:26:53 AM »
Dear Powerlifter

I've read recently that the FDA are trying to change the rules on bone marrow/ stem cells and have them re-classified as drugs! Effectively they, (FDA/ & Big Pharma) want to shut down Dr Centeno & his clinic. Dr Centeno has countered that arguement with the fact that IVF clinics are regularly getting sperm and eggs together and that seems to be fine, yet bone marrow "Tissue" are now to be classified as drugs.

Go figure this is your taxpayers dollars at work. If anyone has recently noticed the economy is in great shape (i am saying this with sarcasm) all thanks to our wonderful governments intervention!

Long may Dr Centeno and his clinic keep doing his great work!

JM

abbaroodle

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Re: Regenexx injections - Stem Cells
« Reply #131 on: April 03, 2009, 05:00:15 AM »
Hi guys,

I am a lurker who unfortunately has a long-standing injury.  I have heard regenexx mentioned a few times in other places, so when I saw this thread, it caught my attention.

While I find the science really exciting, I also find Regenexx and the way it is being carried out pretty worrisome.  For starters, clinical trials require approval by an Institutional Review Board (IRB) which reviews the trial for safety in order to protect the participants.  Regenexx uses the Spinal Injury Foundation's IRB which is directed by none other than Dr. Centeno himself which is clearly a huge conflict on interest!!!  Furthermore, most new clinical trials are free and do not cost thousands of dollars for the priviledge of being one of the first guinea pigs!

I also find Dr. Centeno's marketing approach quite worrisome.  The regenexx procedure seems to have an every growing list of injuries it can cure.  He has many websites and YouTube videos, including the video which shows a patient who got his knees replaced and now regrets his decision since he can no longer try regenexx or any other alternative.  He also went ahead and added in his procedure into wikipedia entries ("Alternatives to Hip Replacement" for example), and seems to promote his procedure widely using any opportunity he can to attract the media and gain attention.  Yes, he is trying to share what he has to offer and "protect" patients from surgery and using any opportunity he can.  But I also feel like he should not be making a small fortune off of a new, experimental procedure.

While I am sure Dr. Centeno is trying to help his patients, I am concerned that he is pushing an untested therapy without taking appropriate precautions targetting people who are vulnerable and willing to try anything to be able to live and exercise without pain. 

Just my thoughts.  Please proceed with caution and know that just because we dont know the risks and dont expect too many associated with a procedure doesnt mean they dont exist!!!  And just because there are some great stories of success doesnt mean it will help you.

Thanks!
« Last Edit: May 31, 2009, 09:45:00 PM by abbaroodle »

Offline mccartjt

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Re: Regenexx injections - Stem Cells
« Reply #132 on: April 05, 2009, 06:08:36 AM »
Abbaroodle

I have something to share with you. We have all read your link from the FDA's website many moons ago. That is old news. If the FDA's open letter & stated postition had a real legal leg to stand on they'd have shut him down many months ago.

Dr Centeno has explained that body tissues / MSC's are not drugs . The FDA regulates drugs that cross state lines. I suspect that the FDA are in breach of their own remit. Across the US, IVF clinics are mixing eggs and sperm without major interference with the use of labs, & the procedure that Dr Centeno has pioneered is essentially done in similar labs. If Dr Centeno breaks Colorado state health rules I am sure that Colorado can shut him down too. Colorado has state attornies don't forget! 

 Having had the procedure, which finished in December 2008, I am now in recovery mode, & this evening I went for a run/walk of over 1 hour. I am feeling great! I have been doing lots of rowing on my Concept2 rowing machine, & today's run/walk felt great. I've gone down a pant size in the last 4 months & each and every week I am getting fitter. Is my knee perfect yet? No; am I much improved? Yes.

Osiris has had (FDA blessed) clinical trials with a similar product called "Chondrogen", that is not autologous but allogenic. My own surgeon believes that the allogenic way forward is dangerous and that autologous is the only way to go. http://www.stemcellnews.com/articles/stem-cells-knee-repair.htm . In fact my ortho surgeon is one of the teaching surgeons at USC where the aforementioned trials were carried out so I feel that I have weighed the pros and cons of this procedure well before diving in.

You may not like Dr Centeno's marketing approach, however are the treatments working?

As for your assertation that this technology is untested, I suspect that the 400+ patients (as opposed to the 48 patients on Osiris trial) that Dr Centeno has seen & treated might have a different opinion. As each week goes by Dr Centeno has increasingly more clinical evidence that his procedures are working.  I do share your concern that there are charlatans out there in the field of stem cells, its my opinion that Dr Centeno is one of the good guys.

JM

Offline GJJ

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Re: Regenexx injections - Stem Cells
« Reply #133 on: April 05, 2009, 05:49:14 PM »
Hello,

I am desperately waiting for a review from the state since my  insurance company will not cover the Regenexx procedure but rather are ok with total knee replacement.  I have seen about 12 orthos and they all differ on the pronosis.  One mistake by one doctor 10 years ago set up a domino effect.  I won't go into the drama. Microfracture should not be allowed especially when you were not aware of it. What was a simple biomechanical issue turned into a growing problem that no surgery will correct.  Based on the research and from following this site, I have concluded that the orthos push for unnessary surgeries that make conditions worst.  I have been waiting for 10 years for a non invasive treatment.  I am not even close to total knee but will end up there if pro active treatment is not provided.  I have been reading and watching the progress on the Regenexx treatment and the FDA should focus their attention else where on others who don't care who they hurt just so they make a buck.  It's my body and mind and I hate when others dictate what is right for me pretending they are doing what is best for me rather what is best their bottom line.  Your body will heal with a little non invasive help.  Stem cell therapies are the future.  Europe has been doing it for years.  We need to leave the politics out and focus more on patient care. >:(

Offline Saverio

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Re: Regenexx injections - Stem Cells
« Reply #134 on: April 06, 2009, 12:44:13 PM »
Well said GJJ  ! ! !