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Stroke Patient Heads to Germany for Adult Stem Cell Therapy

KXMBTV Bismarck, August 14, 2009

Nearly two years ago, Sheila Weiler suffered a stroke during childbirth which left her paralized on her left side. Now, she has decided to travel to Germany in order to receive autologous adult stem cell therapy which is not available in her home country, the United States.

In Germany, Sheila's own adult stem cells will be harvested from her bone marrow through her hip, and after being purified and expanded in the laboratory the stem cells will then be placed directly into the damaged tissue of her brain.

As Sheila describes, "At first I thought it was a pipe dream and I would never really go and this would never really happen. With this I have an opportunity to show my children determination and inner strength and never to give up."

Although none of the reports about Sheila actually mention the particular clinic in Germany to which she will be traveling, odds are that she will probably be visiting the XCell-Center, which is a private institute for regenerative medicine that has clinics in both Dusseldorf and Cologne. The Center is becoming increasingly renowned for its use of adult stem cell therapies in the treatment of a wide variety of medical conditions, including stroke, and since its founding in 2007 the XCell-Center has treated more than 1,600 patients with autologous (in which the donor and recipient are the same person) adult stem cell therapy.

The XCell-Center strictly uses only adult stem cells. At no time are embryonic stem cells ever used in any of the Center's therapies. As described on their website, "The XCell-Center treats patients with their own autologous adult stem cels. It is the first private institute worldwide to hold an official license for the extraction and approval of stem cell material for autologous treatment." As further described on their website, "...therapy with embryonic stem cells is strictly prohibited in Germany. At the XCell-Center, we only use the patient's own stem cells for therapy. ... Because our adult stem cell treatments use stem cells harvested from the patient's own body (autologous cells), there are no ethical or moral concerns."

As in the U.S., autologous adult stem cells are classified as "drugs" in Germany, and therefore require government approval before they can be used in any clinical treatment. Unlike in the U.S., however, German law makes a distinction between "drugs" of individual origin that are for personal use, and drugs that are manufactured by the pharmaceutical industry for large-scale commercialization. As explained on the website of the XCell-Center, "The use of endogenous adult stem cells is ethical and legally straightforward. Under German law, the extracted stem cells are categorized as drugs. Because they are exclusively for personal use, they are individual drugs, and under German law do not require the same governmental approval as other drugs. Despite this, the clinic still has to obtain a manufacturing license from the surveillance authority."

A "manufacturing license" is significantly different from the decade-or-longer, multi-million dollar, multi-phase clinical trial process in the U.S. to which all new "drugs" must be subjected before they can receive FDA approval. Currently in the U.S., even an individual's own, personal, autolgous adult stem cells are required to be scrutinized by the exact same bureaucratic system to which pharmaceutically manufactured drugs are subjected, which involves a lengthy and outdated process that typically takes a decade or longer and costs the sponsoring company hundreds of millions of dollars.

If U.S. federal laws were different, and if autolgous adult stem cell clinics could be set up in the U.S. merely by obtaining a "manufacturing license", as such clinics in Germany are allowed to do, then U.S. citizens such as Sheila Weiler would not be forced to leave their own homeland to travel to foreign countries in order to receive a type of adult stem cell therapy which is not available in the United States but which was, in fact, pioneered in the United States.



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