A stem cell company, which was forced to stop operating in the U.S., has set up a new operation based in Mexico outside of U.S. jurisdiction.
According to the science journal Nature, a controversial company offering unproven stem-cell treatments, has announced that it is to operate from across the U.S. border.
The company is Texas-based Celltex Therapeutics, which was based in Houston. The company marketed its services to people who had suffered tissue damage. The company was offering a treatment process whereby stem cells were taken from patients, then cultured up in a laboratory, before being re-injected to restore damaged tissue. CellTex had been charging patients up to $30,000 for its treatments.
The company was told by the U.S. Food and Drug Administration (FDA) that because the extracted stem cells undergo a level of manipulation that FDA approval is required for such processes, which would have meant that test data would go to the FDA and that the facility would be subject to further federal inspection. The FDA also expressed a concern that findings from a previous inspection had not been addressed.
According to a separate report by Nature, these inspection findings included the FDA making:
"14 general observations about the ways in which Celltex cell-manufacturing procedures are not up to scratch, including failure to ensure the cells are uniform, viable and sterile. These failings are rooted in procedural failures, such as not monitoring the temperature or humidity of the processing rooms and mislabelling or failing to label containers."
The company responded by ceasing its Houston operation, according to Business Week. After an absence of six-months, the company has resumed operations in Mexico.