US Patients Battle the FDA Over Use of Their Own Cells

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American Doctors and Patients Challenge the FDA to Save Lives Rather Than Allow Patients to Needlessly Die

A couple of weeks ago, the American Stem Cell Therapy Association (ASCTA) was formed by a group of doctors, not to debate the pros and cons of embryonic stem cell research and adult stem cell research, but to contest the FDA’s position that a person’s own Adult Stem Cells are to be classified as drugs and subject to the same regulations as Vioxx, Ritalin and thousands of other chemical deadly concoctions.

The FDA’s stance is that a person’s own stem cells must be tested as a new drug- ie. subject to 7-10 years of clinical trials and testing for each disease/condition it is used for.

As I have argued many times before, this stance is ridiculous and is costing millions of lives while sick Americans wait for the use of their own stem cells which would improve their quality of life.

Well, now a group of patients are now targeting the FDA as well.

And they have issued a press release:

A critical initiative for the ASCTA and the Safe Stem Cells NOW! movement is to bring public awareness to the FDA’s position so consumers, and those who stand to benefit from safe stem cell therapies, 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.”

Adult Stem Cells Should Be An Option for Patients With No Options

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.

The FDA Is Not Protecting Us, but Hurting Us

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 Cultured the Same As IVF Cells

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 therefore safest for use in treating patients.

About Safe Stem Cells Now!
The Safe Stem Cells NOW! Movement was started by the American Stem Cell Therapy Association and driven by its patient members. The movement’s goal is to inform patients and physicians that their ability to access safe stem cell treatment is being heavily restricted by pharmaceutical industry agendas and by the FDA. For more information, visit http://www.safestemcells.org

I would appreciate it if you could all take some time to sign up for this new organization. With YOUR help, we may be able to make some much needed changes and get American patients the help that they need.

from Don Margolis

One thought on “US Patients Battle the FDA Over Use of Their Own Cells”

  1. Where on earth did you dig this up? ASCTA no longer exists under that name. Beverly Lessard passed away several years ago.

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