Stem Cell Treatment = Drug

A US federal court rules that procedures in which a patient's own stem cells are extracted, manipulated, and reinjected should be regulated by the FDA.

By | July 30, 2012

image: Stem Cell Treatment = Drug Ampule and syringe on abstract coloured background. Leonardini | stock.xchng

After years of legal wrangling, the US District Court in Washington, DC, last week upheld the Food and Drug Administration's power to regulate adult stem cell treatments in which the cells are more than "minimally manipulated" before being injected back into the patient. The court ruled that the FDA was operating within its legal mandate when it filed suit against Colorado-based stem cell treatment clinic Regenerative Sciences in 2010 to stop them from extracting, processing, and then reinjecting patients' own bone marrow stem cells to treat bone and joint disorders.

The FDA argued that the treatment fell under its purview and was subject to approval like any new drug because the extracted cells were significantly modified using reagents that cross state lines. Regenerative Sciences disagreed, characterizing the treatment as a simple medical procedure, which don’t require FDA approval. The court sided with the FDA, making similar stem cell clinics popping up in the United States take notice. University of Minnesota bioethicist Leigh Turner told Nature that the ruling was spot on. "It is much too simplistic to think that stem cells are removed from the body and then returned to the body without a 'manufacturing process' that includes risk of transmission of communicable diseases," he said. "Maintaining the FDA's role as watchdog and regulatory authority is imperative."

But Chris Centeno, Regenerative Sciences' medical director told Nature that the clinic plans to continue offering patients 3 of its 4 stem cell treatments, in which cells are only processed for 2 days before reinjection. He added that the company will continue to treat patients using the process now prohibited by the FDA in a clinic located in the Cayman Islands and that Regenerative Sciences plans to appeal the court's ruling.

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Avatar of: satansidekick

satansidekick

Posts: 1

July 31, 2012

We donate blood which contains stem cells to the Red Cross who then turns around and sells it for profit isn't a problem at all. 

Avatar of: Candace Barr

Candace Barr

Posts: 1457

July 31, 2012

Q. People keep on talking about Laminine, as well as The new breakthrough Stem Cell Technology. 
What is it? 
A. It is the most powerful Stem cell enhancer
I found amazing infos at: http://lamininestemcell.com

Avatar of: Candace Barr

Candace Barr

Posts: 1457

July 31, 2012

 I've been searching for this Stem Cell for a long time , I'm so much amazed on every one's stories from the news and sites on how stem cells has help them recovered on any type of sicknesses and diseases, even cancer can be cured by this type of treatment. One big factor is that it's not a drug but it will just treat your body in a nice and natural way your body could do to fix them. Stem Cells therapy is nice until i found this Laminine on the Market. People keeps on talking about it saying its the new science breakthrough that I should give a try. It's not a literal stem cell but it is a Stem Cell enhancer, safer than the usual way of Stem Cell Therapy. I found these 
amazing infos at 
http://lamininestemcell.com 
and I gave it a try and in just a few weeks I felt its proven power 
that I also recommend to every one out there. Thanks!

Avatar of: Edward R. Mikol

Edward R. Mikol

Posts: 1457

July 31, 2012

If it is saving lives under its current formulation and usage, the FDA should grant "experimental" waivers for the patients if they are willing to sign off on not bringing  lawsuits against the clinics, doctors and government involved if anything goes wrong.

And then let the FDA continue with the vetting on this procedure and approve it if is efficacious.

"Grandfathering" in a way to keep a worthwhile treatment makes sense if it is proving helpful now.

But it should be examined by outside medical review to make sure it isn't a scam.

Avatar of: vanalex

vanalex

Posts: 2

August 8, 2012

If it's a drug, then it can be used "Off Label," as the opening statement of another article in your current issue points out (News &
Opinion "Off-Label
Drug Disclosure Inadequate," By Hayley
Dunning | August 7, 2012):
"Directly promoting drugs for purposes outside those approved by the US Food and Drug Administration (FDA), so-called “off-labelâ€쳌 use, is illegal for drug companies. However, it is not illegal for physicians and scientists to discuss off-label use with colleagues, deliver lectures, and author peer-reviewed studies."
Then it adds:
"The study’s authors note that because the FDA offers no clear guidance on off-label drug use, expert opinion can have significant impact on prescribing behavior."
We physicians should have the freedom to choose the best treatment for our patients, on or off label. If we want to prescribe beetroot juice or watermelon juice to our anginal patients, in addition to 'standard' therapy, we should be allowed to, with no hassles, if, on the other hand, we want add Allopurinol for those patients that continue to have episodes of angina in spite of current therapy, we should be allowed, even if it's "Off Label."
Had the FDA been in place when most of the pioneering discoveries in medicine were made, we would not have vaccines, X-rays, insulin, salicylates, etc.
It's no secret that passing a drug through the FDA has a price-tag of about US $20 million, when trials and other factors are considered.
I recommend this very well-written article: FDA
regulation and non-approved use of drugs by DOUGLAS PEREDNIA, MD | in MEDS

http://www.kevinmd.com/blog/20... 
Here's an excerpt:

But, of course, the bottom line is that the FDA should not be calling any of our cells, proteins, or any human particle dead or alive, a Drug. The cost of getting a drug approved by the FDA can reach the US $120 million mark, in addition to the basic research (before trials). I totally agree with the Blood Stem Cells example in another comment here. In that case, the "transplant/transfusion" is not even autologous.
Was "minimally manipulated" left there to allow the trasnplant/transfusion of blood stem cells to continue? Will people receiveing a transfusion need to sign an agreement that they accept to have someone else's stem cells transfused to them, along with red and white cells and platelets? We don't always order packed red cells. Does the addition CPD, ACD, Heparin, EDTA, or Irradiation, make blood components into a drug? 

Another excellent article:
Off-Label
Use: Patient Safety and Risk Management Implications
http://www.thedoctors.com/Know... 

Good luck in your appeal, Dr. Centeno!

Thanks.

Avatar of: vanalex

vanalex

Posts: 2

August 8, 2012

If it's a drug, then it can be used "Off Label," as the opening statement of another article in your current issue points out (News & Opinion "Off-Label Drug Disclosure Inadequate," By Hayley Dunning | August 7, 2012):"Directly promoting drugs for purposes outside those approved by the US Food and Drug Administration (FDA), so-called “off-labelâ€쳌 use, is illegal for drug companies. However, it is not illegal for physicians and scientists to discuss off-label use with colleagues, deliver lectures, and author peer-reviewed studies."Then it adds:"The study’s authors note that because the FDA offers no clear guidance on off-label drug use, expert opinion can have significant impact on prescribing behavior."We physicians should have the freedom to choose the best treatment for our patients, on or off label. If we want to prescribe beetroot juice or watermelon juice to our anginal patients, in addition to 'standard' therapy, we should be allowed to, with no hassles, if, on the other hand, we want add Allopurinol for those patients that continue to have episodes of angina in spite of current therapy, we should be allowed, even if it's "Off Label."Had the FDA been in place when most of the pioneering discoveries in medicine were made, we would not have vaccines, X-rays, insulin, salicylates, etc.I recommend this very well-written article: FDA regulation and non-approved use of drugs by DOUGLAS PEREDNIA, MD | in MEDShttp://www.kevinmd.com/blo... Here's an excerpt:But, of course, the bottom line is that the FDA should not be calling any of our cells, proteins, or any human particle dead or alive, a Drug. The cost of getting a drug approved by the FDA can reach the 120 million US $ mark, in addition to the basic research (before trials), and 6 to 13 years. I totally agree with the Blood Stem Cells example in another comment here. In that case, the "transplant/transfusion" is not even autologous.Was "minimally manipulated" left there to allow the trasnplant/transfusion of blood stem cells to continue? Will people receiveing a transfusion need to sign an agreement that they accept to have someone else's stem cells transfused to them, along with red and white cells and platelets? We don't always order packed red cells. Does the addition CPD, ACD, Heparin, EDTA, or Irradiation, make blood components into a drug? Another excellent article:Off-Label Use: Patient Safety and Risk Management Implications
http://www.thedoctors.com/Know...
Good luck in your appeal, Dr. Centeno!
Thanks.

Avatar of: Jack Lante

Jack Lante

Posts: 2

November 18, 2013

Stem cells - this is a business that can compete with the trade in arms or drugs, and that the country has a strong stem cell bank will be more significant argument than oil and gas. I know that with early embryonic cells operate some foreign clinics.

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