Thread: Stem cell orthopedics
11/28/2010 1:34pm, #11
The clinic is very candid and publishes their data.
The "dance" you refer to seems disingenuous as well when:
Colorado Medical Clinic Welcomes Opportunity to Fight FDA in Court
Clinic Claims FDA Has Repeatedly Overstepped Regulatory Authority
DENVER, Aug. 9 /PRNewswire/ -- Regenerative Sciences, Inc., a Colorado medical practice that specializes in the use of a person's own stem cells to help patients avoid more invasive orthopedic surgery, announced today that the US Food and Drug Administration (FDA) is seeking to enjoin the clinic physicians from practicing medicine using patients' own stem cells. The lawsuit will allow Regenerative Sciences to question the FDA's policy that adult stem cells can be classified as drugs when used as part of a medical practice."For two years we've been prodding the FDA to respond to our questions about how it has the ability to regulate a medical practice, so we're encouraged that, as a result of this recent suit, the courts will decide if it the FDA has regulatory authority over the adult stem cells that live in everyone's body," stated Centeno. "This is an important case for everyone that suffers from any type of illness, not just patients with orthopedic problems. It will decide, once and for all, if the government has the right to restrict a patient and their doctor from using a person's own stem cells to treat disease. Regenerative Sciences believes that stem cells are body parts and not the property of the government or big pharma."
11/28/2010 1:47pm, #12
11/28/2010 2:02pm, #13
They've been doing this for several years, it's surprising they don't have a proper RCT with even a small number of patients.
Please elaborate, you seem to be contradicting yourself.
A small number of patients over several years would lead to quick conclusions how?
The 'time and money' you spend doing it is what distinguishes real medicine from snake-oil.
That's just PR, the reality of the situation is that they're trying to avoid being regulated by the FDA.
Yes they are, did you read the quotes or the article i linked?
The "dance" is addressed in the quote above...
These are your cells, not a drug.
It may be that they even win the case, I am not deeply au fait with US medical law, but that doesn't stop this being an experimental treatment at best and total quackery at worst.
"At best" this could revolutionize medicine as we know it.
It is IN FACT an "experimental" procedure.
"Total quackery" is unlikely at this point.
11/28/2010 2:26pm, #14
According to their own site they've treated more than 450 people.
Homeopathy or faith healing will look like they works if you survey the patients after the treatment and ask them if they feel better, which is why science is not done that way.
11/28/2010 3:02pm, #15
Ah, ok. That makes more sense and fair enough.
Not sure, but from the literature i gather that they are not really interested in kowtowing to the FDA at this point because of the landmark nature of this case.
Further they seem unwilling to do so prematurely, after all your proposed study could just as easily be dismissed due to the small sample.
It is certainly novel. That doesn't mean you don't have to prove it works.
What unfounded allegations? By 'dance' I meant the legal proceedings they are, in fact, going through. Whatever horribly pejorative meaning meaning you've read into it was not my intention.
"Avoiding" is not the same as questioning the right of the agency iin question.
On the contrary i think they are doing a good thing by questioning these
What speculation, precisely?
OK, that's true of any suggested procedure. Homeopathy or faith healing will look like they works if you survey the patients after the treatment and ask them if they feel better, which is why science is not done that way.
Do you really think that they are relying on the subjective measures that you describe, despite all of the MRIs they publish?
How is asking if someone feels better even relevant here?
No, there is ample evidence that this is a valid procedure, unlike homeopathy.
We know what stem cells do, roughly.
We can measure cartilage growth.
If after a procedure, and nothing else has changed, how else would you explain marked objective improvement?
Why do you think that? Without speculating on their motives, they might well think it works and be wrong.
How do you explain the client i had then?
11/28/2010 3:18pm, #16
Last edited by PointyShinyBurn; 11/28/2010 3:21pm at .
11/28/2010 3:56pm, #17
- Join Date
- Aug 2008
- Kickboxin & Shootfightin
Personally i think this type of technology is awesome. Not yet fully understood or applied but awesome none-the-less. Have heard of a few examples of stem cells being injected into problem areas with some pretty amazing results. People taking back ground on things like Alzheimers kinda amazing.
As for understanding the process??. They can already deliberately produce spinal cord material from stem cells, heart valve (?i think), and can take an adults tissue and strip away all of the extra bits to reduce it back to what is essentially the equivalent of infant stem cell material, so the tech is kinda understood (reverse engineering anyone? lol). Its the building it back up into the specific thing you want that still has alot of room for growth,but they are already doing it for limited items in the body.
11/28/2010 4:15pm, #18
11/28/2010 4:30pm, #19
Nice cherry picking PSB.
You're all over the place man...
Subjective vs objective, speculation, argument from ignorance, poisoning the well etc etc...
WTF, you just having fun or am i supposed to be buying this bs?
So because you can't read an MRI they are invalidated?
BTW, there is such a thing as a clinical approach to research...
11/28/2010 4:38pm, #20
What they are doing is cowboy stuff. You might not mind, but if people choose to sign up for this they need to know what they are getting into.