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US Doctors Group Organize to Challenge the FDA
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.