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http://www.thedenverchannel.com/health/19307188/detail.html
Broomfield Clinic Patients Call Stem Cell Treatment 'A Miracle'
'Non-Controversial' Treatment Uses A Patient's Own Stem Cells, Not Embryos
Christin Ayers, 7NEWS Reporter
POSTED: 7:52 pm MDT April 27, 2009
UPDATED: 11:24 pm MDT April 27, 2009
[NEWSVINE: Broomfield Clinic Patients Call Stem Cell Treatment 'A Miracle'] [DELICIOUS: Broomfield Clinic Patients Call Stem Cell Treatment 'A Miracle'] [DIGG: Broomfield Clinic Patients Call Stem Cell Treatment 'A Miracle'] [FACEBOOK: Broomfield Clinic Patients Call Stem Cell Treatment 'A Miracle'] [REDDIT: Broomfield Clinic Patients Call Stem Cell Treatment 'A Miracle'] [RSS] [PRINT: Broomfield Clinic Patients Call Stem Cell Treatment 'A Miracle'] [EMAIL: Broomfield Clinic Patients Call Stem Cell Treatment 'A Miracle']
A small Broomfield clinic is quietly trailblazing a revolutionary stem cell treatment for orthopedic patients.
Adult stem cell treatment comes without the controversy of embryonic stem cell treatment because it uses a patient?s own harvested and multiplied stem cells to treat knee injuries and broken bones.
Dr. Christopher Centeno, who cofounded the Broomfield-based Centeno-Schultz Regenexx Clinic, said the procedure may one day replace the need for orthopedic surgery.
?Adult stem cells are ultimately going to be a huge mainstay of treatment for a lot of different problems,? said Dr. Centeno. ?The field is exploding.?
The treatment is still relatively new, can cost thousands of dollars and is not currently covered by any health insurance providers.
During the procedure, a patient?s stem cells are removed, using a needle. They are taken to a lab and multiplied and later, reinjected into the affected area.
For some patients, doctors say the treatment quickly starts rebuilding damaged tissues.
One of those patients is Hal Kaye.
?I got on my treadmill and did my first mile where a year before that, 100 yards was a job,? said Kaye, an accountant and avid sportsman who loves golfing and once worked as a high school and college basketball referee before the arch in his foot collapsed 15 years ago.
Kaye said four ankle surgeries left him nearly crippled. Dr. Centeno said the fourth surgery drove a screw through an important artery in Kaye?s ankle, causing the bone to die off and collapse and the cartilage on top of the bone to wear away.
?When I first saw Hal's X-ray, it looked like someone had taken a bunch of screws from the hardware store and thrown them at the picture,? said Centeno.
?My quality of life deteriorated drastically,? Kaye said. ?Golf was done in a cart with a handicap flag on the cart with a cane hanging from my golf bag.?
On the verge of a fifth surgery, which would have involved an ankle fusion, Kaye went to an informational session about the Regenexx Clinic?s adult stem cell treatment.
Doctors deemed Kaye a good candidate for the stem cell treatment. Kaye said two months after the first injection, he stopped limping and using a cane. Six months and two injections later, Kaye is running daily on his treadmill.
For now, the Regnexx treatment is strictly used on some orthopedic patients, from osteoarthritis sufferers, to knee replacement candidates. Dr. Centeno said soon, adult stem cell treatment could replace orthopedic surgery altogether.
Centeno said he believes if the success of the treatment continues, health insurance coverage is not far off.
1oceanspirit says:
?Thank you god!
HeidioftheRockies says:
?There is great promise for these treatments, but he's got a looooong way to go before health insurance will pay for this. Wishful thinking! Insurance companies reward invasive, debilitating procedures, not preventative or regenerative care.
lynz says:
?i need a hip replacement,and i would like to have him try it on me,
since i have all that wrong with me. Im 52.
Concerned! says:
?Insurance coverage is a long way off for one reason because it is currently ILLEGAL for Dr Centeno to provide such treatment. He received a warning letter from the FDA. He has started a mass-campaign to change the laws rather than abide by them.
While I believe the science is extremely promising, there is also a lot of potential for danger! No one knows the long-term effects and possible risks, such as cancer, that this treatment may provide. Please be very, very careful before enrolling!!!
Not-So-Concerned says:
?Saying the Regenexx procedure is "currently illegal" is disingenuous at best. It is NOT currently illegal. Fertility clinics have been re-implanting lab-expanded cells for years now after successfully challenging the FDA's regulation attempts. I am aware of big pharma-sponsored donor adult stem cell trials currently underway in the USA, and am suspicious of the FDA's interest in claiming regulatory authority over the autologous (meaning "your own") adult stem cell treatments like Regenexx. Big pharma can't do autologous, they can only make $ on a donor-based therapy (i.e., "off-the-shelf" at an MD's office).
In any case, the FDA does a less-than-perfect job of assuring drug safety anyway (can you cay Celebrex or Bextra?), and they are certainly at least influenced by pharmaceutical interests.
And even though we are not talking about any actual "laws" here, as I recall a certain Dr. Martin Luther King sponsored a "mass campaign" to "change the laws rather than abide by them".
Uhm says:
?For a good guide for what to look for in stem cell therapys, take a look at this patient handbook.
http://www.isscr.org/clinical_trans/pdfs/ISSCRPatientHandbook.pdf
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 motions hearing. Will be interested to see how this turns out!!!
http://dockets.justia.com/docket/court-codce/case_no-1:2009cv00411/case_id-111707/
IVF clinics are required to use culture media that are FDA approved. The FDA's problem is not with the procedure but with Centeno using unapproved culture media to grow the cells.
(And IVF isnt exactly without problems last I checked!!! Or do you think giving birth to octets is something to be praised as advancing science and personal choice?)
The FDA is far from perfect. But they have mechanisms in place to ensure that drugs like bextra and vioxx are taken off the market once there is evidence that they are not safe. There are systems in place to monitor them. And the FDA is working on ways of improving post-marketing survelience as we speak because you are right - it is a problem!
The FDA does not make money off of approving drugs. And they are way over worked and have more than enough to do without regulating stem cells. They are not doing it for the sake of being difficult. They are doing it for the sake of keeping patients safe. And it is clear that patients lack the knowledge to keep themselves safe!!!
Regardless of whether or not it is legal, I would be very, very careful before trying out an experimental therapy even if the doctor thinks it is totally safe and without risks. The fact that someone does not talk about risks makes me even more worried!!! There are always risks and the question is do you want to be the guinea pig who may benefit, or who may end up spending a lot of money on treatment that doesnt work, or worse yet, treatment that makes you worse and requires you to spend even more money treating the cancer you might get in a year or two, or the infection you might get the next day.
JLS replies:
?Uhm, you wrote "The FDA is far from perfect. But they have mechanisms in place to ensure that drugs like bextra and vioxx are taken off the market once there is evidence that they are not safe". To that, I say to you, that the job of the FDA is to find the evidence that a drug is not safe BEFORE they approve the drug. Special interest groups, big pharma influences the FDA approvals and make big profits selling these drugs.
When that drug harms or kills someone it is then, and only then, that the FDA comes back and takes the drug off the market. And this is after years of the drug companies making huge profits from the sale of the unsafe drug at the cost of one or more lives! FDA approval no longer means a drug is safe. I was foolish enough to believe FDA approval assured me the drugs were safe for years. It doesn't tak a rocket scientist to figure out what is going on at the FDA.
Now the FDA wants to claim OUR stem cells as a drug to profit big pharma, as usual. What is happening now is simply obstruction on the part of the FDA for profit.
They do not want a cure for any condition being treated by big pharma's high priced drugs. They put monitarial greed over peoples lives! It is transparent to see that the FDA and special interest groups do not care about our health.
Autologous stem cell therapies are extremely promising in leading to major medical advancements, including cures, with low side effects, if any.
Here are links for those interested in stem cell therapy using your own cells.
Patient Movement Forms in Opposition to FDA Position that the Patient's Own Stem Cells are Drugs http://tinyurl.com/cyyv57
Conversation on Facebook about this topic
http://tinyurl.com/chvh66
Thank God for Dr. Centeno and all the other doctor joining him in this fight for all of us to be able to use our own stem cells for treatment. Many of us are joining the fight and you will find much information and answers to your questions at this link:
www.safestemcells.org
Very active and informative stem cell forum:
http://www.stemcellpioneers.com
Dr. Centeno says:
?Dear all,
This is Dr. Centeno. Interesting discussion.
First, the FDA approves drugs and devices, but is strictly prohibited by congress from interfering with the practice of medicine. There is nothing illegal about what we're doing.
The FDA is trying to assert that the patient's own stem cells are drugs, see www.safestemcells.org. Since this makes no sense and isn't about patient safety, we have formed a professional organization to put in place guidelines to ensure safe stem cell therapy, see www.stemcellsdocs.org. These guidelines will improve upon FDA's drug guidelines that were developed to ensure safe drug manufacture, not the use of a patient's own stem cells as treatment.
To the commenter above who has concerns about culture media. There is no FDA approved culture media that IVF clinics are privy to at this point. Not sure where you got any information about any issues with our culture media as we grow stem cells using the patient's own growth factors from their blood platelets, not serum based culture media.
We have a patient tracking database of over 450 patients and are spent allot of time making sure we track every patient for complications. We have had no significant stem cell related complications in almost 4 years.
On a more personal note, what is interesting is what just happened to me on the plane home from a medical conference and taking the kids to Disney. A little boy the same age as my twins was very sick from liver and kidney transplants. I attended to him as the only MD on the plane. After hearing his history, this boy's life has been a misery from day one. He is now on multiple immune suppressant drugs to stay alive and any little infection could place him in the hospital or worse. This is a kid who with the advent of safe stem cell therapies would have likely never needed those transplants or those drugs. So to put it all in perspective, while Big Pharma figures out how best to commercialize the patient's own adult stem cells as drugs, kids like this aren't getting the treatment they need. I'm a pain doctor, but through the American Stem Cell therapy Association and other specialists in these areas, very soon, kids like this will get treated with their own stem cells, not transplants and lifetime drugs to keep them barely functional.
Chris Centeno, M.D.
Guest replies:
?Thank God for pioneers like him. The FDA would rather the rest of us die before approving anything that involves something besides a drug that costs a lot of money. It's all about the money with the FDA - not about life. Dr. Centeno should be commended. If you don't like his treatment, you don't have to use it, but don't dictate to the rest of us!
Stem Cell Pioneers says:
?Uhm and Concerned - which pharmacuetical company do you work for? The nerve of Uhm to say that patients lack the knowledge to keep themselves safe. I am co-founder of the Stem Cell Pioneers forum and will go one on one with you any day about knowledge of stem cell therapy. The forum is the largest patient moderated forum there is for stem cell discussion and support. We have very knowledgeable researchers, doctors, PhD's and other professionals as members. We have an extensive library of articles on stem cell research and therapy. Many members suffer from terminal or chronic diseases for which there are no known cures. Stem cells offer us hope in a way that you will obviously never know. The FDA has declared our own stem cells to be drugs. ASCTA (www.safestemcells.org) is the grassroots effort started by Dr. Centeno and one which the Stem Cell Pioneer forum heartily endorses. We are not advocating unsafe procedures. On the contrary. We want safe stem cell treatment to be available now in the U.S. and we want the doctors that treat us to be able to manipulate the cells to an extent to make them clinically relevant. ASCTA has put together safe guidelines for doctors and laboratories. What doesn't make sense is condemning millions of people to death by calling their own stem cells drugs. This in turn will require that clinical trials be done for each and every disease and every application for it. Heaven help you if you have an "unpopular" disease that no one wants to do a clinical on. I have been fortunate enough to have been able to go outside the U.S. and have treatment. It has stopped the progression of my disease. I cannot let my good fortune leave others behind. There are many forum members that are too sick to travel or simply cannot afford the expense to do so. We must be allowed to make these decisions for ourselves as the alternative is dying and that option in my opinion is not at all safe. Fertility clinics that manipulate cells are not being stopped from the procedure. How do you justify double standards? Do our lives mean nothing to you in your quest to keep big pharma in its cradle to grave drugs for all position? The FDA should become a model for change. President Obama campaigned on change and transparency and I can think of no other regulatory agency that is in need of these things more than the FDA. We are talking lives here. Real people who cannot wait 10 years. There are thousands of published articles already available for study. Clinicals tend to restrict the sickest who are the most needy. Dr. Centeno is not in this fight alone. I urge everyone to join ASCTA, and in turn contact the FDA and your legislators with your comments. Your life could depend on it someday. Barbara Hanson/Stem Cell Pioneers
Not so dumb says:
?In reply to "Uhm"-----I was a patient being considered for lung transplant. Once I was set up to see transplant doctors, which meant having every test possible on the human body; I delved into lung transplants. I just soaked up knowledge in reading whatever I found on the subject. I asked my doctors here and the transplant doctors at the Clinic every question I could write down. And there were a lot of them. I also went into several forums and read what had to be said about transplants. I found a person who had had a lung transplant and learned even more. The whole process. The ups, the downs. Then he told me about a sight that had to do with stem cells. He said that he wished he had known about stem cells before because he's have never had the transplant. So, I went to this forum and joined. I didn't speak with anyone in the forum for months. I fed on the information that the participants were discussing and reporting. I went to the several websites that they would speak of and did my own research. This was the most aware and knowledgeable site I had ever run across. I learned so much from them. Sure, there are people out there that just want to know how to do it, where to get it and how much does it cost. But then, there are those of us who actually DO care about our well being. We listen, we discuss, we share and we are there for one another when we're needed. When it comes to our health, we are NOT so dumb. Nor, do we NOT care about "keeping ourselves safe". How safe was I when the FDA okayed Celebrex and my doctor prescribed it for me? After about 8 months of being on it----the FDA said, "oops"!!!! When my ex husband found out that I was going to have stem cell therapy he sounded a bit like you, Uhm. Like I was really stupid for doing it when it was not yet legal to do here. Called me a guinea pig. I told him that at some point and time, there were other people who "tried out" the drug he was taking for his high blood pressure. And thanks to those people, he was able to be prescribed that drug. I also pointed out to him that I and oh so many others, are not dummies just rallying after the newest thing out there. But that we are doing more than just sitting back and doing nothing and getting sicker and sicker. We are educating ourselves on our treatments. These cells in MY body?--- they are mine. They do NOT belong to the FDA or anyone else. It is not up to the FDA to tell us what THEY want done with our cells, our blood or our body parts. So please don't profess that we "lack the knowledge to keep ourselves safe". I AM a stem cell recipient who has halted her disease. And I AM a Stem Cell Pioneer.
Tim says:
?I have had one surgery on my ankle which was not successful. This December I am due for a ankle fusion. Would this stem cell therapy be a viable option?
Stem Cell Pioneers replies:
?Not according to Uhm or concerned who would scare you off with stories of cancer and horrible infections. I haven't seen such uneducated posts in a long time. Thousands of people have had autologous stem cell therapy. Do you hear thousands of stories of cancer and infection among those recipients? Hardly. These scare tactics are not going to work because we are educating ourselves. I would heartily recommend that you contact Dr. Centeno at his clinic and ask him. He will give you a fair and honest answer I am positive. I have no connection to his clinic other than being a supporter of safe stem cell clinics and doctors who are willing to put themselves on the line for their patients who deserve better than what Ohm and Concerned would wish on us. Your surgery was not successful. To me, stem cell therapy would be something that I would certainly look into if I was in your shoes. The risks are far less than with surgery which is an invasive procedure.
Barbara Hanson/Stem Cell Pioneers
nassin replies:
?My condition with severe emphysema at the end of 2006 made my life
miserable until I had autologous stem cell therapy from my own bone
marrow performed in a foreign country. My quality of life
has been vastly improved and although already 80 years old, I continue
to travel abroad every six weeks. My doctor is very happy that
I had the treatments. He has seen my improvement. I cannot
understand why the FDA allows nicotine to be sold over the
counter yet makes it difficult for doctors to help patients on the last stage of their illness when they cannot help them any more with conventional medicines. Nassin Yarhi
a concerned citizen says:
?While this debate is a much bigger one than this message board could handle, I have grave concerns with the FDA. Aren't these the guys who constantly put the public in harms way and then only after people die over years and years of profitable drug production, take the drug off the market? i.e. Baycol and Vioxx etc etc. How are we supposed to believe that the FDA is out there to protect me? I believe that my doctor should have the right to use my own body's bi-products to treat my own bodies conditions. Dr.'s have been doing this for decades and I think it is high time we say know to special interest groups that pursade the FDA!
Henry E. Young, PhD (MUSM) says:
?I have been researching adult-derived non-hematopoietic stem cells for over 35 years. I have performed non-invasive and invasive studies in 11 different species of mammals, including humans. I have never seen normal adult, autologous stem cells produce any type of cancerous tissue throughout my studies. During my more than 35 year research career I have discovered adult-derived autologous germ layer lineage multipotent stem cells, pluripotent stem cells, and totipotent stem cells present in the connective tissues of these mammals, including humans, and most recently, circulating in an inactive state in the vasculature of large mammals, i.e., pigs, horses, and humans. While normally inactive, these circulating primitive stem cells are already present, and when the need arises, are activated for the normal maintenance and repair of the individual. Every time you cut yourself, stub your toe, tear a muscle, crush-damage a nerve, or break a bone, what do you think is repairing those dread tissues inside your body? It is a combination of your immune system, to remove the dead tissue and debris, and your own endogenous autologous stem cells to replace the missing tissue. Each person?s body is using their own stem cells right now, whether the FDA approves of them or not, to maintain, repair, and heal the normal wear and tear on the body.
Individuals, like Dr. Centeno, are utilizing expanded autologous stem cells to assist in the repair of abnormal situations where extensive damage has occurred and overwhelmed the person?s normal repair processes. To do this procedure, autologous stem cells can be removed from a person?s body, expanded ex vivo (outside the body), and then transplanted back into the body to assist in repair of the defect. With respect to growing cells ex vivo, i.e., outside the body, the FDA disapproves of using animal proteins in any type of culture media . . . AND RIGHTLY SO. Their fear is that there is the potential for the transfer of animal diseases, like BSE (bovine spongiform encephalitis), to the cultured cells and then into the body. To safeguard the expanding stem cells, there are commercial companies that have formulations for media that are composed of human recombinant proteins and tissue culture-approved reagents for the SAFE growth and expansion of these stem cells.
I am one of the individuals that prepared the ASCTA booklet for growing adult stem cells for human transplant. I believe, by following these guidelines to the letter, that adult-derived stem cells (or any non-embryonic stem cells) can be grown and expanded, and will be safe for human transplant.
Guest says:
?Someone said "No one knows the end result of stem cell treatment"
Well as someone who has only 25% of their lung function I have no doubt what the end result will be for me without stem cell treatment. Some of us are disabled or in debilitating pain. Tell me what the end result will be without stem cells?
I don't understand the people who are against getting your own cells when the FDA has no problem with people getting other peoples' blood in a transfusion. How is that approved by the FDA but not receiving YOUR OWN STEM CELLS? There is more to this than the FDA worrying about our safety considering they allow hundreds of drugs with terrible side effects to be sold every day.
Fed UP says:
?The FDA is VERY corrupt. Over 90% of the "geniuses" on the board who approve the drugs have some sort of financial conflict of interest in approving drugs. Why don't they want to approve your own cells? Because it will cost 90% of those jokers money. It isn't about your health or your well being. The FDA is a joke and yes many of you will die hoping. I bet they will pump you full of drugs until the day you die though. It's terrible that many don't have the funds to go over seas but even worse that we don't have a government that can't see the value in this. Good luck to you all!! I am a healthy 34 year old and am praying this is available when I need it someday. My mom on the other hand is not on the right end of this situation though. My problem is you have stooges like UHM that don't get that some of these people are dying quickly. Do you really think the first thing on their mind is, "is this going to kill me"? Get real. The people above are WILLING to go through what ever it takes to feel better. Would you rather see them roll over and die? They see a shiny light through a hallway and want the opportunity. I guess I can see what this guys etrade account looks like. A bunch of drug companies I bet.
Harv says:
?"Harv from Stem Cell Pioneers says:
How dare the FDA even pretend to know what is safe?
I have had 4 name brand or generic drugs I take recalled in just over a year, most of them due to unsafe lab practices! I now only take drugs that have been released for 10 or more years. By doing this, I am relying on "track record" and user reviews, and can forget about what the FDA says is "safe". To hell with an organization that is in bed with whatever drug company is the highest bidder on a particular day! I will be the sole judge of what is safe and proper for my medical use and care after (possibly) consulting with a doctor
JC the Fox says:
?Receiving FDA approval is a long, drawn-out procedure. Fortunately, some companies, such as Osiris, are in the process of doing just that. For me, waiting more years for the approved drugs (I still have problems with calling stem cells a drug)isn't much of an option, since I've been told I'm in "end-stage" emphysema. I can no longer work, so the cost to go out of country to receive any type of stem cell therapy is not a possibility. And the truth is, I don't trust many of those "clinics" who are located outside the US borders. My hope is to receive autologous stem cell therapy (which may be the final answer) at least to allow me the time to wait until something else comes along.
