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The U.S. Food and Drug Administration has received a complaint alleging the Houston company involved in Gov. Rick Perry's unregulated adult stem-cell operation is a potential danger to patients and not in compliance with federal law.
In an eight-page letter sent last month, University of Minnesota bioethicist Leigh Turner called on the FDA to investigate Celltex Therapeutics Corp., which banks people's stem cells for future reinjection in the event of disease or injury. Perry was the company's first customer last year.
"It appears their business plan involves injecting or infusing on a for-profit, commercial basis non-FDA-approved adult stem cells into paying customers," Turner wrote in the Feb. 21 letter. "This plan conflicts with FDA regulations governing human stem cells."
An FDA spokeswoman declined comment, but Turner said an agency official told him the matter has been assigned to an investigator and is being taken seriously.
Celltex co-founder David Eller said Tuesday night he is confident the company will "meet all FDA specifications." He emphasized that Celltex doesn't administer stem cells, but stores and processes them at the behest...
In an eight-page letter sent last month, University of Minnesota bioethicist Leigh Turner called on the FDA to investigate Celltex Therapeutics Corp., which banks people's stem cells for future reinjection in the event of disease or injury. Perry was the company's first customer last year.
"It appears their business plan involves injecting or infusing on a for-profit, commercial basis non-FDA-approved adult stem cells into paying customers," Turner wrote in the Feb. 21 letter. "This plan conflicts with FDA regulations governing human stem cells."
An FDA spokeswoman declined comment, but Turner said an agency official told him the matter has been assigned to an investigator and is being taken seriously.
Celltex co-founder David Eller said Tuesday night he is confident the company will "meet all FDA specifications." He emphasized that Celltex doesn't administer stem cells, but stores and processes them at the behest...
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