Celltex had hoped to culture and bank cells with its partner RNL Bio, before the two became embroiled in legal action.
Tyler Rudick
US citizens who wanted to have stem cell treatments without travelling overseas may soon be able to get them south of the border. Celltex Therapeutics of Houston, Texas, ceased treating patients in the US last year following a warning from regulators. A 25 January email to Celltex customers indicates that Celltex will now follow in the footsteps of many other companies offering unproven stem cell therapies and send its patients abroad for treatmentbut no farther than Mexico.
Celltex had been offering stem cell treatments for more than a year starting with Texas Governor Rick Perry in July 2011 when the US Food and Drug Administration (FDA) wrote to the company on 24 September advising it that the stem cells it harvested and grew from customers were more than 'minimally manipulated' during Celltex's procedures. As such, the FDA regarded the cells as drugs, which would require the agency's approval to be used in treatments. The FDA also warned that Celltex had failed to address problems in its cell processing that the inspectors from the agency had identified in an April 2012 inspection of its cell bank in Sugarland, Texas. Shortly after the letter, Celltex stopped injecting stem cells into patients.
For customers who still had cells banked at Celltex and were wondering how to get them out, things became more chaotic when Celltex and RNL Bio, a company based in Seoul which operated the processing centre and bank, sued each other. Celltex had to issue a restraining order just to access the cells.
The January email from Celltex reassures customers that their cells are safely stored in a facility in Houston and adds, We anticipate that we will be able to offer our stem cell therapy services to physicians in Mexico starting very soon! The email adds that the company is constructing a new laboratory, to be opened in March.
Celltex also says it will carry out an FDA-approved clinical trial, to start shortly after a March meeting with the FDA. However, the company had said in a 25 October email to patients last year that it would start such a trial within two months and that patient enrolment could begin as early as 30 days after that.
University of Minnesota bioethicist Leigh Turner says the move to Mexico is "not surprising," given the companys difficulties in the US.
Since Celltex's stem culturing and banking technology was licenced from RNL Bio, it's also not clear whether on its own it will still have the expertise needed to launch a clinical trial, says Turner. "It would have to build a stem cell company from the ground floor up. I wouldnt say they are anywhere near the starting line."
Celltex did not respond to questions about how it would ship stem cells to Mexico or how it would perform the clinical research needed to seek FDA approval.
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Controversial stem-cell company moves treatment out of the United States