FDA Part 1: Adult Stem Cells found in everyone’s body are drugs, subject to regulation and monitoring

Fact:

The FDA announced their recent position that adult stem cells (cells found in everyone’s body) are “drugs” and should be monitored, controlled and regulated by the FDA.  The FDA will be able to tell you when and how they can be used. Even if your life could be saved by a stem cell transplant from your own body and to your own body, you may first have to receive approval from the FDA before getting treatment.

Book excerpt:

“We live in a time when one fifth of all our genes are owned by someone else, and an unsuspecting person and his family can be pursued cross-country because they happen to have certain valuable genes within their chromosomes . . .” – “Next” by Michael Chrichton

Tomorrow?:

Plans are in the works to regulate your urine, feces, spit, sperm and all other bodily fluids and organs.  These bodily fluids, etc. , once regulated, will be legally available to pharmaceutical companies for purchase, ownership, patent and exclusive distribution.

Summation:

You don’t have to go to a foreign country to live out the urban legend of waking up in a bathtub full of ice with a kidney or liver or stem cells missing.  It can happen right here in the US.  The only difference is, here it will happen in broad daylight and with the full approval and backing of the FDA, the US goverment, legal courts and health care industry.  Does this sound preposterous?  Conspiracy theorist? Ridiculous?

I wish.  Read on… -dg

FOR IMMEDIATE RELEASE

Physician Group Opposes FDA’s Position on Adult Stem Cells

BROOMFIELD, COLO. (March 24, 2009)-The American Stem Cell Therapy Association announced today the on-line publication of its mission statements and charter.  The organization was formed in response to the FDA’s recent position that the adult stem cells found in everyone’s body are drugs, a position the ASCTA opposes. This physician organization is establishing laboratory guidelines which will allow doctors to bring adult stem cell therapy to their patients more quickly.  These guidelines will be similar to those used by fertility specialists in In-Vitro Fertilization labs, where many of the same cell culture techniques are used.

“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.” stated Christopher J. Centeno, M.D.  “ASCTA is establishing guidelines which will allow the safe use of the patient’s own adult stem cells under the supervision of doctors.” continued Centeno.  Another ASCTA physician member, Frank Falco, M.D. stated, “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.”

Adult stem cells are different from embryonic stem cells.  These cells are found in the patient’s body in various tissues.  In order to obtain enough stem cells for treatment, they often need to be cultured, similar to today’s fertility treatments. Adult stem cells have undergone much more research than embryonic stem cells and thus are closer to real world treatments.  These adult stem cells are taken from the patient’s own body (autologous) and ACSTA believes that they are therefore the safest for use in treating patients.

The ASCTA is a physician group comprised of various medical and surgical specialties whose goal is to bring safe stem cell therapy to patients by establishing laboratory and clinical guidelines.  See www.stemcelldocs.org .  Christopher Centeno, M.D. is a board certified pain management specialist in Colorado who utilizes The Regenexx Procedure, an innovative adult stem cell therapy that helps patients avoid the need for more invasive orthopedic surgery.  Dr. Centeno has published numerous medical research papers on the clinical application of adult mesenchymal stem cells. Frank Falco, M.D. is a board certified pain management physician and program director of the Temple University Hospital pain medicine fellowship located in Philadelphia, Pennsylvania who implements minimally invasive techniques for treatment of painful conditions including degenerative spine disorders.

via http://www.stemcelldocs.org/Media_Room.html