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Patient Movement Forms in Opposition to FDA Position that the Patient's Own Stem Cells are Drugs
Date:4/9/2009

apies, have the opportunity to be heard. "We get letters and calls every day from people suffering from a variety of conditions and diseases that have no known cure who are eager to access stem cell therapies.", Hanson adds. "Many of them are forced to look outside the U.S. for treatment, which involves prohibitive travel and procedure costs."

One of those patients is Beverly Lessard, a 71-year-old patient from Florida, who has been diagnosed with end stage emphysema. Her late-stage condition prohibits extensive travel and the estimated cost of $12,000 to $50,000 is unaffordable. "At 71 years of age there is little interest on my part or anyone else's to opt for lung transplants. I think this is disgraceful for our FDA to prohibit the use of autologous stem cells except in a very narrow concept so that people are forced to seek relief outside the USA," wrote Lessard.

Adult stem cells are ready for early clinical use now and can be processed with the same techniques commonly used in existing in-vitro fertilization labs. "Classifying them as drugs will not add to patient safety, but it will delay treatment to patients who don't have 1-2 years to wait, let alone 5-7 years," stated Christopher J. Centeno, M.D., a founding physician member of ASCTA. "ASCTA has established lab guidelines which will allow the safe use of the patient's own adult stem cells under the supervision of doctors," continued Dr. Centeno.

Adult stem cells are different from embryonic stem cells. Adult stem cells are found in the human body in various tissues. In order to obtain enough to treat a condition or disease, 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 ASCTA believes that they are
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Patient Movement Forms in Opposition to FDA Position that the Patient's Own Stem Cells are Drugs
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