19 replies to this topic

[rwac]

Exclusive: Colorado Doctors Skirt FDA Jurisdiction to Provide Stem Cell Therapies
The FDA has yet to approve stem cell therapies for general use in medicine, but that hasn't stopped doctors in Colorado from providing them anyway. Chris Centeno and John Schultz have boldly formed Regenerative Sciences Inc. in Broomfield, Colorado. RSI provides its patients with the Regenexx procedure, an adult stem cell transplant that uses your own cells (autologous) to treat joint injuries and bone damage. There's no surgery needed. A needle extracts bone marrow, RSI isolates the stem cells and cultures them in your own blood, and then these cells are injected into the area where they are needed. They've treated 348+ patients with 800+ injections and show no signs of slowing down. According to RSI's own surveys, 89% of their knee patients showed marked improvement, as did 75% of their hip patients! Within months some patients can walk or run in ways they haven't been able to in years. We've seen these kinds of results from stem cell treatments before, but only in horses and dogs. That's because human stem cell therapies like this one aren't approved by the FDA. How can Centeno and Schultz flaunt the lack of federal approval? They claim that Regenexx is solely used as a part of their medical practice, only within the state of Colorado, and as such is no more regulated by the FDA than it would be by the FAA or the Department of Motor Vehicles. I had a chance to talk with Dr. Centeno over the phone and learn more about Regenexx and RSI. For hundreds of patients, he and his team are providing a remarkable hope. They've brought lab-cultured medical stem cell therapies to the US. Finally.

http://singularityhu...herapies-video/

Does this sound legit ?

[niner]

Hey, more power to 'em. At least now people don't have to go to China or have a friend who's a veterinarian. However, their legal argument sounds a little bit like those whack jobs who've decided that they don't have to pay taxes. People have been doing this procedure to good effect in dogs for a while now. 'Bout time. But if it goes south on someone, is everyone going to freak out?

[Ghostrider]

Hey, more power to 'em. At least now people don't have to go to China or have a friend who's a veterinarian. However, their legal argument sounds a little bit like those whack jobs who've decided that they don't have to pay taxes. People have been doing this procedure to good effect in dogs for a while now. 'Bout time. But if it goes south on someone, is everyone going to freak out?

Can docs in Canada treat with stem cells?

[lunarsolarpower]

However, their legal argument sounds a little bit like those whack jobs who've decided that they don't have to pay taxes.

Really? It seems like they're on fairly solid ground to me. Obviously that's assuming the procedure doesn't have any horrific surprises waiting for them. In that case they could end up in a pickle. However what they're doing is practicing medicine, not wholesaling or retailing a pharmaceutical product. As long as they practice proper informed consent and people realize that the treatment is new and unproven I think they're fine. If anything, the party that might have the biggest problem with their activity would be their malpractice insurer.

Edited by lunarsolarpower, 10 March 2010 - 07:55 AM.

[Logan]

The doctor I have seen for platelet rich plasma treatments is trained to do the hip bone marrow stem cell treatments, he's just waiting to figure out a way to make them more affordable before he starts offering them to his patients. I think because these treatments involve the use of our own stem cells the FDA cannot do anything about it. The FDA didn't have to approve PRP therapy did they? No, PRP is not a stem cell treatment, none the less, there was no FDA approval needed for doctor's to start using PRP on their patients. It's our own blood and our own stem cells that we are choosing to use. I don't believe the FDA has any jurisdiction in this particular field of orthopedic treatment. I'm surprised this was not given as a reason by the Regenexx people and the person that wrote this article.

BTW, PRP works, at least it has on me so far. I will definitely be going back for more treatments.

[Solarclimax]

Does this stuff work ? i have seen videos where people with 1 leg and people in wheelchairs see videos and articles about people that have revolutionary surgeries in places like china, and the video shows them walking and gives the impression their quality of life has improved. Then they go and actually meet the patients in person and its a different story. The videos and articles where hyped up and gave people false hopes when in actual fact the procedures/surgeries basically did next to nothing. But it's big business so they try and chalk it off as something really amazing with use of video editing and misleading information. This is a very low thing to be doing. And undermines any real advancements being made. It makes people think twice about the claims of any new procedures that say they can do this and that to make you better. So not only is it out of order trying to earn money of people who can't walk ect, but it also undermines any new procedures that are more worthwhile. Just throwing this out their. To avoid any confusion I'm not referring to anything in this thread.

Edited by Solarclimax, 10 March 2010 - 09:28 AM.

[kismet]

Probably not legit. I hope the responsible hucksters go to prison.

[Logan]

Probably not legit. I hope the responsible hucksters go to prison.

O.K., it's good to be skeptical but you really should think about what you are saying. Think about it. Stem cells from you own hip bone marrow used to heal your own joints. This doesn't sound like it could be legit? Do you think the use of platelet rich plasma(which is growing more and more in it's use) for joint issues is legit?

You're comment, "I hope the responsible hucksters go to prison", just sounds full of bitterness and hate. Is that the kind of person you are? I'm beginning to think so.

Edited by morganator, 12 March 2010 - 08:51 AM.

[bobman]

I know a very highly respected doctor whose practiced is linked to them. They're very legitimate, and good for them. Fuck the FDA and their anachronistic, highly-lobbied policy decisions. I love that every pharmaceutical on the market can be prescribed "off-label" for anything on earth and get covered by insurance, but something that is super effective and low-cost gets shunned. A typical orthopedic surgery (shoulder, 2.5 hour) costs $40k to an insurance company. This procedure costs about $8k for 2-3 injections. Both can have the same effect. This procedure won't cure a retracted tear, but it can heal fibrocartilage, partial and full thickness tears, and generally anything as long as it hasn't degenerated too far. Best of all, if it doesn't give the results you're looking for, you have plenty of options. Surgery is not like that. I've had a lot of experience with orthopedic surgery at a young age, and so far it has ruined my life. The statistics on successful surgery look great, until you realize that the followups are generally about 1 year. Partial minesectomy was considered a very successful technique, until it was recently discovered that 10 years later like 90% of people have lost large swaths of articular cartilage. Stuff like that. I'm ranting, but I spend a large portion of my time living and researching this nightmare.

Edited by bobmann, 12 March 2010 - 11:48 AM.

[bobman]

Probably not legit. I hope the responsible hucksters go to prison.

No offense, but you're a maroon.

[Solarclimax]

No offense, but you're a moron.

x2

Edited by Solarclimax, 12 March 2010 - 02:50 PM.

[Logan]

I know a very highly respected doctor whose practiced is linked to them. They're very legitimate, and good for them. Fuck the FDA and their anachronistic, highly-lobbied policy decisions. I love that every pharmaceutical on the market can be prescribed "off-label" for anything on earth and get covered by insurance, but something that is super effective and low-cost gets shunned. A typical orthopedic surgery (shoulder, 2.5 hour) costs $40k to an insurance company. This procedure costs about $8k for 2-3 injections. Both can have the same effect. This procedure won't cure a retracted tear, but it can heal fibrocartilage, partial and full thickness tears, and generally anything as long as it hasn't degenerated too far. Best of all, if it doesn't give the results you're looking for, you have plenty of options. Surgery is not like that. I've had a lot of experience with orthopedic surgery at a young age, and so far it has ruined my life. The statistics on successful surgery look great, until you realize that the followups are generally about 1 year. Partial minesectomy was considered a very successful technique, until it was recently discovered that 10 years later like 90% of people have lost large swaths of articular cartilage. Stuff like that. I'm ranting, but I spend a large portion of my time living and researching this nightmare.

If these types of treatments were mainstream I probably would not have had four arthroscopies a yea and a half ago-bilateral knee and 2 hip. I totally regret having at least 2 of them.

[bobman]

I know a very highly respected doctor whose practiced is linked to them. They're very legitimate, and good for them. Fuck the FDA and their anachronistic, highly-lobbied policy decisions. I love that every pharmaceutical on the market can be prescribed "off-label" for anything on earth and get covered by insurance, but something that is super effective and low-cost gets shunned. A typical orthopedic surgery (shoulder, 2.5 hour) costs $40k to an insurance company. This procedure costs about $8k for 2-3 injections. Both can have the same effect. This procedure won't cure a retracted tear, but it can heal fibrocartilage, partial and full thickness tears, and generally anything as long as it hasn't degenerated too far. Best of all, if it doesn't give the results you're looking for, you have plenty of options. Surgery is not like that. I've had a lot of experience with orthopedic surgery at a young age, and so far it has ruined my life. The statistics on successful surgery look great, until you realize that the followups are generally about 1 year. Partial minesectomy was considered a very successful technique, until it was recently discovered that 10 years later like 90% of people have lost large swaths of articular cartilage. Stuff like that. I'm ranting, but I spend a large portion of my time living and researching this nightmare.

If these types of treatments were mainstream I probably would not have had four arthroscopies a yea and a half ago-bilateral knee and 2 hip. I totally regret having at least 2 of them.

I just saw your post. Yeah, I had 4 shoulder surgeries, from ages 21 to 23. After the last one, possibly due to the stress on my body, I blew out both knees and my right hip 9 months ago. I mean the full meniscal/labral tear pathiology. I decided I'd had it with surgeries, and so just rehabbed them. My knees aren't perfect, but good enough for running, or even kickboxing. My hip has healed just fine.

If I'd been a little wiser, I would have said no to the initial surgeries 3 years ago. Our medical system is not what it professes to be. I wish that I had at least been warned of the complications, and given real statistics on success rates. Because I've read that real long term success from labral tear fixation (especially bicep anchor repair), is down near the 20%'s, but certainly less than 50%. It depends on how they evaluated success. I deem it "return to previous level of activity".If that's the criteria, success is very very low.

[Logan]

I know a very highly respected doctor whose practiced is linked to them. They're very legitimate, and good for them. Fuck the FDA and their anachronistic, highly-lobbied policy decisions. I love that every pharmaceutical on the market can be prescribed "off-label" for anything on earth and get covered by insurance, but something that is super effective and low-cost gets shunned. A typical orthopedic surgery (shoulder, 2.5 hour) costs $40k to an insurance company. This procedure costs about $8k for 2-3 injections. Both can have the same effect. This procedure won't cure a retracted tear, but it can heal fibrocartilage, partial and full thickness tears, and generally anything as long as it hasn't degenerated too far. Best of all, if it doesn't give the results you're looking for, you have plenty of options. Surgery is not like that. I've had a lot of experience with orthopedic surgery at a young age, and so far it has ruined my life. The statistics on successful surgery look great, until you realize that the followups are generally about 1 year. Partial minesectomy was considered a very successful technique, until it was recently discovered that 10 years later like 90% of people have lost large swaths of articular cartilage. Stuff like that. I'm ranting, but I spend a large portion of my time living and researching this nightmare.

If these types of treatments were mainstream I probably would not have had four arthroscopies a yea and a half ago-bilateral knee and 2 hip. I totally regret having at least 2 of them.

I just saw your post. Yeah, I had 4 shoulder surgeries, from ages 21 to 23. After the last one, possibly due to the stress on my body, I blew out both knees and my right hip 9 months ago. I mean the full meniscal/labral tear pathiology. I decided I'd had it with surgeries, and so just rehabbed them. My knees aren't perfect, but good enough for running, or even kickboxing. My hip has healed just fine.

If I'd been a little wiser, I would have said no to the initial surgeries 3 years ago. Our medical system is not what it professes to be. I wish that I had at least been warned of the complications, and given real statistics on success rates. Because I've read that real long term success from labral tear fixation (especially bicep anchor repair), is down near the 20%'s, but certainly less than 50%. It depends on how they evaluated success. I deem it "return to previous level of activity".If that's the criteria, success is very very low.

Yeah man, screw surgery unless it is absolutely necessary. I haven't had an ACL in my right knee since tearing it in half playing youth league football. As long as I was strength training and stretching and in good shape I could do just about anything over the years. I should have thought about this before I decided that surgery was the answer a few years ago. Now I'm very interested in platelet rich plasma therapy and hip bone marrow stem cell treatments.

[Luna]

Cool! I want to see more advanced stuff happening FDA approved or not! as long as they have been on trial for safety carefully enough.

Edit: I thought I'd add something I had in mind, although about cruel.

We all know there is a lot of "it could lead to cancer" kind of thinking around stem cell therapies, and although it's been under vets use for years, it's still there.

So even though it seems highly unlikely that it's there, this treatment and those people taking it ,for good or for worse, will be able to either break or reinforce that notion in the coming 10-15 years so if broken those kind of treatments will advance much more rapidly in humans and when we REALLY NEED it for things like heart and brain problems and life saving procedures, then we are much more likely to have them.

Not that making people walk again is doesn't apply to REALLY NEED and truly great, but my point is that it is the first step for people here to look forward and say "We are on the path" to what a great part of this meme is quite about.

(And quality of life is part of the meme, so it is a good first step!)

Edited by Luna, 07 July 2010 - 06:35 AM.

[chris w]

Yes, I don't know why Kismet commented they way he did, if those people where informed about possible dangers and about what they can realistically expect from the therapies, I say go with it.

I think that this "Wild West" period had to happen sooner or later, and the sooner the better, so that people who are desperate to try anything that has a chance of helping them, don't have to wait for a faceless agency to figure stuff out. What FDA doesn't approve, FDA doesn't get blaimed for if things go shitty, this should be as simple as that.

[Logan]

Yes, I don't know why Kismet commented they way he did, if those people where informed about possible dangers and about what they can realistically expect from the therapies, I say go with it.

I think that this "Wild West" period had to happen sooner or later, and the sooner the better, so that people who are desperate to try anything that has a chance of helping them, don't have to wait for a faceless agency to figure stuff out. What FDA doesn't approve, FDA doesn't get blaimed for if things go shitty, this should be as simple as that.

I don't think there really are any risks in procedures like this, and if there are, they are minimal. The risks are definitely much much lower than any risk involved in some of the less invasive orthopedic surgeries like arthroscopic surgeries.

I think it's ridiculous that it doesn't take much for the FDA approves fairly invasive cosmetic procedures like Fraxel CO2 laser, but when it comes to something that is not invasive and has potential to really positively change people's lives, they don't show any interest. Could it be a money issue? Is the FDA really benefiting financially from approving certain procedures?

[albedo]

Probably not legit. I hope the responsible hucksters go to prison.

What makes you say so?

[albedo]

In case your have missed it, there is an article in the Life Extension Magazine (Jan 2011):
http://www.lef.org/m...d-by-FDA_01.htm
I would be very interested to know about people who were treated with or without success at Renegexx (or similarly elsewhere)

[david ellis]

I too, am waiting for homologous stem cell therapy. The fat pads in my feet have moved or shrunk, making it painful to walk. I thought I would soon be wheelchair bound, but discovered that super duty hiking boots and orthotics greatly reduced my pain. But I am still uneasy about the future, because the time could come when the boots won't work because there is still some pain and plenty of numbness in my toes.

Autologous stem cell/fat therapy is common place in cosmetic surgery. A Beverly Hills podiatrist regularly injects fat pads into women's feet enabling them to walk in high heels. (autologous stem cells and fat). Autologous stem cells and fat are also used to remedy bags under the eye. It is also done for breast augmentation. I challenged my podiatrist some time ago, hopefully soon this will cross over into routine medicine.