Tag Archive for 'drug'

Doctors Organization Publishes U.S.’s First Adult Stem Cell Guidelines

In a bold move that is sure to shake the foundations of the United States FDA, a group of American doctors have published a set of strict clinical guidelines that will allow US doctors to treat patients with their own Adult Stem Cells.

Your Own Stem Cells Are Not a Drug

This move by the American Stem Cell Therapy Association comes in response to the FDA’s position that a person’s own stem cells should be classified as a drug, thus subject to the exact same set of standards that a drug like Viagra or Lipitor or Vioxx would be examined under.

However, these US doctors are correct in believing that adult stem cell therapy with the patient’s own cells is governed under the practice of medicine, not under drug production guidelines.

From the stem cell press release:

Adult stem cells can be processed with the same techniques commonly used in existing in-vitro fertilization (IVF) labs. “Like the human cells and tissue used in IVF, adult stem cells are not drugs,” stated Christopher J. Centeno, M.D., a physician who worked on the guidelines and whose medical practice includes the use of the Regenexx procedure, which uses patients own stem cells to treat orthopedic conditions.

Slowing Progress, Costing Lives- the US FDA at Work

“Making the stem cells in your own body a drug won’t make them safer, will dramatically reduce availability of treatment, and will increase bureaucratic red tape.” stated Dr. Centeno.

Dr. Centeno is absolutely right.  These are your own cells and having the FDA regulate your own body won’t be helping anybody as there is no downside to having your own stem cells implanted.

Let me repeat that- there is no downside to having your own Adult Stem Cells implanted. Either they will help you or they won’t (no effect).  This has been proven in thousands of studies.

Your own stem cells should be an extra tool your doctor should be able to use to help you.  No, adult stem cells are not a cure yet, but they do help in the majority of cases.

Again, your own stem cells should be a tool in your responsible doctor’s tool kit that may or may not be able to help, but should be made available to you as there is no downside.  What does the patient have to lose?  A man in end stage heart failure about to die- give him his own stem cells, they should help. He may not be beating Husain Bolt in a 100 meter sprint, but should improve.  A spinal cord injury victim, give him his own stem cells, they should help.  He/she may not be walking, but it could be beneficial in some ways.  A diabetic, give him his own stem cells- they should improve his insulin levels. And if your own stem cells don’t help- there is no harm done- thousands of studies have proven this.

And what if your own Adult Stem Cells work only 5% of the time for a particular lethal disease and your doctor wants to try to save your life? Hey! It will save 5% more than zero. With no downside, why not? And if the FDA has its way, that 5% will be 0. It is up to all of us to make a stand. And these clinical guidelines are the first step.

If you are a patient of any kind and reading this, I urge you to go to Safe Stem Cells Now, a patient run organization demanding the use of their own stem cells.

Maybe you can find something interesting in the following sponsored links:

The FDA Is Killing Adult Stem Cell Therapy Thus Killing Patients

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In a startling new interview on stem cell research and adult stem cells in the near future, Dr. Christopher Centeno warns that Big Pharma and the FDA are teaming to control the use of a person’s own stem cells thus slowing innovation and the use of Adult Stem Cells to help patients now.

American Stem Cell Therapy Association

Dr. Centeno has formed the American Stem Cell Therapy Association to challenge the FDA’s assertion that a person’s own stem cells are a drug and thus should be regulated as such ie. subject to 7-10 years of clinical trials for each particular disease and condition.  That is 10 years for heart patients, 10 years of trials for stroke patients etc.

The FDA is Killing People By Slowing Down Use of a Person’s Own Stem Cells

The article/interview in H+ magazine states:

If we’re not careful, these therapies could become the exclusive domain of the pharmaceutical industry, as regulated by the Federal Food and Drug Administration (FDA). This could push the availability of this tool kit 15 to 20 years into the future. The opportunity-cost in terms of morbidity and mortality could be catastrophic.

“The Opportunity-cost in terms of morbidity and mortality could be catastrophic? This is just the author’s nice PC way of saying that the FDA is killing people by trying to regulate the use of our own cells.  If the FDA slows down the use of Adult Stem Cells- each year millions will suffer and die needlessly.

More from the article:

To Dr. Centeno (a pioneer in Adult stem cell therapy), it is inconceivable that a person’s own cells could be classified as a drug —  but that’s exactly what the FDA wants to do. “The FDA is working to protect the interests of Big Pharma,” he says. “If we wanted to insert some kind of new genes into these cells, we might all agree that could be a drug  — a new entity. But what we’re doing is simply culturing a person’s own cells. Most of the cells are bone-marrow derived; you can get them from synovial fluid in the knee or from other locations.”

I recommend you read the whole article carefully and see how the FDA is not helping and protecting and serving us-  but in reality, is hurting us.

Here is the link to the Adult Stem Cell article

If you are a doctor and interested in joining forces with Dr. Centeno in taking on the FDA- go to the http://www.stemcelldocs.org

If you are a patient or just interested in fighting the FDA for the use of our own stem cells- go to http://www.safestemcells.org

original post by Don Margolis


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