March26 , 2009 in STEM CELL RESEARCH

American Doctors Take On the FDA's Authority on Adult Stem Cell Use

While the United States is debating the pros and cons of Embryonic stem cell research, a group of American doctors are sidestepping this debate and have united to challenge the US Food and Drug Administration's (FDA) assertion that Adult Stem Cells taken from the patient's own bodies are to be classified as drugs.

This group has formed the American Stem Cell Therapy Association (ASCTA) in response to the FDA's stance on Adult Stem Cells. The FDA's stance is that stem cells removed from a patient should be treated as a new drug- ie. subject to 7-10 years of clinical trials and testing for each disease/condition it is used for.

American Doctors Finally Speak Up For Adult Stem Cells

Dr. Christopher Centeno MD of Regenexx, in Colorado- "Many patients are dying or suffering day by day with incurable diseases or problems that require major surgery. These patients should have access to basic adult stem cell therapy now"

Frank Falco, M.D. in Delaware/Maryland- "The FDA's position against someone using their own stem cells is taking it too far. We are talking about a person using their own tissue to treat a degenerative disorder or process safely without the use of medications or surgery. Although we agree that oversight and standards are necessary, this should be provided through a physician organization such as ASCTA rather than by a government agency."

Dr. Zannos Grekos, Naples, Florida, a member of the Repair Stem Cell Institute's Science Advisory Board, is also a member of the ASCTA.

FDA's Stance On Your Own Stem Cells

The FDA's stance on Adult Stem Cells taken from a patient is that it should be treated as a new drug- ie, subject to 7-10 years of clinical trials and testing for each use of it. This means 7-10 years of clinical trials for adult stem cells for heart disease. 7-10 years of clinical trials and tests for diabetes, 7-10 for spinal cord injury...you get the picture.  Think about how much money and how much time it will take to get through the hurdles for each particular disease/condition.  How many people will die  and suffer during that time  because they can't be treated with their own cells- which are safe and have no side effects.

Adult Stem Cells- the same as Lipitor or Viagra?

Cells taken from your own body are being treated by the FDA  exactly the same as Lipitor or Viagra were treated.  Lipitor and Viagra have side effects (ex. Lipitor- muscle weakness, Viagra- risk of heart attack) because you are introducing a new foreign chemical into your body.   Adult Stem Cells are not some mysterious concoction of chemicals brewed up after 10 years of research and development.  The Adult Stem Cells are your own cells-  removed from a patient so they have no side effects.  They are safer than taking an aspirin.

Stem Cells- Your Own Repair System In Place

In essence, your own stem cells are already there to repair damage to the body, let the body heal itself.  When you fall and scrape your knee, your body will send stem cells to heal the damage. However, sometimes for certain conditions and diseases, there aren't enough of these stem cells to do that.  Therefore, these doctors/researchers are multiplying the amount of adult stem cells and then putting them into the area that needs repair- and then they let the body's own repair mechanisms (the adult stem cells)  do what they are "born to do"- no controversy, no ethical concerns, a 3rd grader can understand this- so why shouldn't it be  available in the United States?

These American doctors are finally speaking up and I (and thousands of patients who can benefit from using their own stem cells) applaud them.