April 21, 2014



US Stem Cell Company Heads to Mexico After FDA Reprimand

February 3, 2013

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Not all stem cell research involves the use of human embryos. Adult stem cells, amniotic stem cells and induced pluripotent stem cells do not involve human embryos.

The attack on stem cell research has driven at least one regenerative medicine company to seek friendlier climes south of the border.

Six months after the federal government forced it to stop its treatments, the Houston-based Celltex Therapeutics moved its operations to Mexico to avoid the long arm of the law.

The U.S. Food and Drug Administration told the company last September that because its cells are more than “minimally manipulated,” Celltex must seek federal approval before injecting stem cells into patients. The FDA warning comes on the heels of an April 2012 warning to the company that it had inadequately addressed problems with its cell processing procedures, including failing to maintain laboratory controls and to thoroughly investigate any unexplained discrepancies.


“While Celltex respectfully disagrees with the positions outlined in the September 24 letter, Celltex believes that this technology’s therapeutic potential can be brought to fruition as a biological drug as the agency states,” stated a letter from the company to the FDA.

Stem-cell therapy is an intervention strategy that introduces new adult stem cells into damaged tissue in order to treat disease or injury. Researchers hope to soon be able to treat cancer, diabetes mellitus, Parkinson’s disease, Huntington’s disease and Celiac disease among other ailments through the procedure.

US Stem Cell Company Heads to Mexico After FDA Reprimand [continued]




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