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Author Topic: Regenexx injections - Stem Cells  (Read 223903 times)

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Offline mccartjt

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Re: Regenexx injections - Stem Cells
« Reply #105 on: February 05, 2009, 06:38:18 AM »
Lee

Its been 8 months since the FDA open letter was posted by Miss Malarkey via their website. Since you are the attorney here, on what grounds can a Federal agency (FDA) start regulating an intra state issue? I can't see how they would have standing in a Denver court.

I am sure any attorney could put up a spirited defense to have the FDA's attorneys petition thrown out of court, just in chambers!  I suspect that the FDA has weighed up their options and have decided rightfully with the law as it now stands their petition would not hold up. I mean does it really take 8 months to prepare a lawsuit to shut someone down?

OTOH  & with all things considered should laws change then the out come could well be different.

On the issue of safety, Dr Centeno would have his patients files as evidence of GMP & the clinical outcomes.

My own surgeon was not too impressed with the clinical trials allowed for Osiris and their allogeneic stem cells, & in fact he strongly recomended against becoming one of Osiris's guinea pigs in their recent clinical trials.

JM

Offline Tailwind

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Re: Regenexx injections - Stem Cells
« Reply #106 on: February 05, 2009, 04:29:18 PM »
Lee

Thanks for the post. I am scheduled to begin this procedure soon.

I am an attorney involved with financial matters. I have friends and former colleagues who work for the government in areas related to my work. While they would never come out and say "I am working on an enforcement action against X company", at times it is possible to predict who may be the subject of an inquiry based on other things these people do and say and who they are talking to. I have two questions for you. Do you have such information and is that the basis for your prediction? Also, are you certain that the FDA's response to Regenexxwas silence, or could this matter have been resolved between Regenexx and the FDA in some other non-public way?

Thanks!
10/06 - Man v. Dog Collision
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Offline mccartjt

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Re: Regenexx injections - Stem Cells
« Reply #107 on: February 06, 2009, 05:15:34 AM »
Lee

A couple of points here come to mind.

1) What is the FDA going to do if Dr Centeno's patients mostly have positive outcomes? & better out comes than Osiris 's clinical trials? Then the genie is truly out of the bottle?

2) I 'd like to know what was the intent of your original posting ?

JM

Offline Saverio

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Re: Regenexx injections - Stem Cells
« Reply #108 on: February 12, 2009, 02:50:15 PM »
Hi All,

I haven't posted in a while.  Thought I check in and give an update.  It is almost 5 months since my regenexx treatment on my right knee.   I had my left knee done in March '08.  I am very glad I had both knees done.  I am able to play singles tennis 3-4 times a week.  I have even played 4 days in a row once.  The major difference I have experienced is that there is hardly any inflammation after I play.  I still ice my knees after playing but even pros do that.  I do it because it's the smart thing to do at my age (58).   I have also noticed that I am benefitting more from my exercises.  I feel my knee joints are getting stronger.  Pre regenexx there was too much pain for the surrounding muscles to strenghthen.

There is a thread on PRP started by GB that is interesting.  PRP sounds similar to regenexx but without the stem cells and a whole lot cheaper ($200-$600).  I did some checking.  I was just wondering if there are more people who have undergone PRP treatments on the knees.

Saverio

Offline 60schld

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Re: Regenexx injections - Stem Cells
« Reply #109 on: February 12, 2009, 11:13:23 PM »
 Thanks for your post Saverio, glad you are doing well.  Could you please let us know what PRP is and exactly where is this thread?  I'm not understanding the abbreviations.  Thanks, 60schld :D
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Offline Saverio

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Re: Regenexx injections - Stem Cells
« Reply #110 on: February 13, 2009, 01:50:14 PM »
60schld

PRP is Platlette Rich Plasma.  There is a thread started http://www.kneeguru.co.uk/KNEEtalk/index.php?topic=46074.0  under Injections in the joint.

Saverio

Offline mccartjt

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Re: Regenexx injections - Stem Cells
« Reply #111 on: February 13, 2009, 06:36:45 PM »
Hi Saverio

It sounds like you are doing well. I hope your condition continues to improve.

I've had a conversation with another former/current patient of Dr Centeno. Its was his experience that some where after 90 days post final injection (& up to six months), that major real improvements may take place in one's injured joint. Whilst personally I've probably been too keen with my overall physical rehab, I have to hope I've not damaged the current stem cell procedure ongoing in my knee. I am hoping that (based on his experience)  in the next month to 4 months time my repairing stem cells, will start turning into cartilage in my knee .

This technology is all so brand new it doesn't surprise me that big pharma is interested in following this thread of how people in the real world get their bad joints fixed.

Good luck to all

JM

Offline Saverio

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Re: Regenexx injections - Stem Cells
« Reply #112 on: February 14, 2009, 02:00:03 PM »
JM

You are right about this technology being new.  Food for thought.  Imagine being one of the 1st patients to receive a Total Knee Replacement.  How scary is that.  We are in the same category for receiving stem cell treatment to enhance cartliage growth.  And we are doing great.

Saverio

Offline thevoice

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Re: Regenexx injections - Stem Cells
« Reply #113 on: February 15, 2009, 07:33:38 PM »
I have read so many articles of compaines planning on doing stem cell trials to repair cartalidge that it must be in double figures now. I really hope this technogoly moves forward quick and becomes the reconsized standard of treatment for cartalidge defects/ware and tare etc I think this could happen within the next 5 years and we could see things like microfracture/ACI/MACI/knee replacements for arthritis become a thing of the past.

Offline Dr. Centeno

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Re: Regenexx injections - Stem Cells
« Reply #114 on: February 16, 2009, 11:22:21 PM »
Wow!  I'm always amazed at how the internet is such a great discussion generating tool.  It's been a few months since I checked this site.  Just to clarify a few points:

1.  I was surprised to see Lee Bucker posting here.  I know Lee owns a commercial cell therapy industry blog and I have communicated with Lee as he relayed.  My comments to his concerns are posted at http://celltherapyblog.blogspot.com/2009/02/regenexx-vs-fda-2009.html?showComment=1234374420000#c5662649568093779579

2.  We have used prolotherapy for years and still use this technique.  Prolo is what I call Regenerative Medicine 1.0.  It's the injection of a substance to prompt an inflammatory healing response.  It works great on ligaments and chronic tendon enthesopathies.  It brings the patients own growth factors and cellular mechanisms to bear.  The upside of prolo is that it's very inexpensive and simple to deploy.  The downside is that because there is big biologic variability in growth factor quality, blood supply, and healing potential of patients, it has a reasonably high failure rate.  However, because of it's low expense and ease of use with limited downside, it's a great technique to try. 

3.  PRP and BMAC have also been discussed here.  PRP uses a bedside centrifuge to spin down platelets and concentrate them.  Platelets have all kinds of great growth factors including PDGF, TGF-beta, IGF, FGF, etc...  This type of technology is great for helping to heal things that are close to healing on their own.  Hence it's been used by many athletes to get them back into the game more quickly.

BMAC is what Dr. Lee does.  It uses a bedside centrifuge to spin down the nucleated cell fraction of a bone marrow aspirate.  About 1 in 50,000-500,000 of those cells is a stem cell capable of orthopedic repair.  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.  After we used it for a year and treated 10 patients or so with pre/post MRI's, we abandoned it in favor of what the research community has done for years, which is to grow mesenchymal stem cells in culture to much larger numbers.  There is a post on this issue here: http://www.regenexx.com/2009/02/bone-marrow-nucleated-cell-concentrate-bmac-is-it-concentrated-enough/ 

I would call these centrifuge based treatments (PRP and BMAC) that concentrate autologous (the patient's own) blood products "Regenerative Medicine 2.0". 

4.  I would call what we do "Regenerative Medicine 3.0".  This is what has gotten big pharma and it's representatives so upset.  In our medical practice, we isolate and then culture expand mesenchymal stem cells in our state of the art cGTP lab in Colorado.  This allows us to deploy thousands of times more stem cells capable of orthopedic repair than could be mustered with the 2.0 techniques (BMAC).  We didn't start seeing reliable results with patients until we started using this procedure to grow stem cells for short periods of time in culture.  While using a centrifuge and doing this at the bedside is easier, you just can get enough orthopedic repair cells in my opinion. 

Hope this helps.  Thanks for the kind words!

Chris Centeno, M.D.

Offline slyguy1

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Re: Regenexx injections - Stem Cells
« Reply #115 on: February 20, 2009, 04:36:48 AM »
For someone who has had microfraction....which also involes the bone marrow forming a matrix. Would it be too late to have a stem cell procedure? My thinking is that the area of bone that is drilled will eventually be arthritic with time and anything else done would not be effective. One other question....microfraction healing time is very long....at least a year in some cases but progress beyond that is minimal....with this procedure do you have to be reinjected after some time to continue getting benefit? Thanks for the great info....

Offline mccartjt

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Re: Regenexx injections - Stem Cells
« Reply #116 on: February 20, 2009, 05:56:49 AM »
Hi Slyguy

Your question is a real and valid question for maybe someone who is more knowledgeable than the folks on this board. I have had the procedure done and have found that Dr Centeno and Dr Schultz both professional and courteous. Perhaps an email directly to Regenexx's clinic might help here?

I will share this with you, most people's outcome on stem cell / cartilage regrowth therapy, is unknown at the begining. We all hope for the best, when you get your bone marrow draw, however there are numerous factors that determine the final outcome of your procedure. I am two months post my final injection and my condition is still improving. I was able to row for 20 mins this evening without pain. Yes my knee is getting better & stronger!

Good luck to you. 

John Mc

Offline rob8647932

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Re: Regenexx injections - Stem Cells
« Reply #117 on: February 20, 2009, 02:22:21 PM »
Slyguy,

I have had mutiple microfracture surgeries with limited success. I had the Regenexx in both knees post microfracture with some success as well. It seems to be a work in progress. The Regenexx can only help whatever arthritic condtion is going on. Best to ask Centeno though. But I am sure it would NOT be contraindicated.
Left knee - 1997 debridement, 1999 trochlea paste graft / microfracture), 2002 IAGH injections, 2005 plica and synovium removal, 2009 Regenexx injections
Right knee - 1997 debridement, 2000 trochlea paste graft, 2004 IAGH injections, 2008 Regenexx injections

Offline BearsCubs

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Re: Regenexx injections - Stem Cells
« Reply #118 on: February 20, 2009, 05:00:50 PM »
SlyGuy,

I'm in (was) the same boat as you, having a microfacture during a scope on 4/30/08 and not liking the "quit playing sports" prognosis the ortho gave me. So actually on a whim I entered "microfracture" into google about a week later, and up popped a you tube video from Dr. Centeno that was about 9 minutes along explaining microfracture and then his procedure. The rest, as they say, is history and I had my bone marrow draw in late May, first injection in mid June, second reinjection in mid July, and then just had my third and hopefully final one (not that the injection itself is bad, but the travel to and from can get expensive) in mid January.

Since this procedure is still relatively new I'm sure long term results won't be known for a while. What I CAN tell you is that my knee feels much better and am looking forward to return to ultimate frisbee very soon. Take care.

Offline Dr. Centeno

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Re: Regenexx injections - Stem Cells
« Reply #119 on: February 28, 2009, 02:34:36 PM »
CSU is doing a research study for the Steadman-Hawkins foundation where they place mesenchymal stem cells in with a micro fracture treatment.  This is an equine study and the results won't be available until fall of 09.  Other animal models have shown that this process forms better cartilage than MF alone. 















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