Menu

Stem-Cell Clinic Moves to Mexico

A company offering experimental stem-cell treatments will carry out its procedures in Mexico after the FDA warned that it would need approval to operate in the U.S.  

Feb 1, 2013
Dan Cossins

Human autologous mesenchymal stem cellsCOURTESY OF CELLTEXSix months after it was forced to stop treating patients in the United States, a controversial company offering unproven stem-cell treatments has told its customers they will now be sent to Mexico for the procedures, reported Nature.

Houston, Texas-based Celltex Therapeutics offers treatments in which stem cells are extracted from patients, cultured in the lab, and then re-injected to restore damaged tissue. It had been carrying out the procedures on US soil for a year when last September the Food and Drug Administration (FDA) advised the company that because the cells are more than “minimally manipulated,” federal approval is required to inject them into patients. The FDA also told Celltex that it had failed to adequately address problems with its cell processing procedures identified during an April 2012 inspection of its cell bank in Sugar Land, Texas.

In response, the company stopped offering its stem-cell treatments to US patients. Celltex also got involved a legal dispute with RNL Bio, a Seoul, South Korea-based company that operated the Celltex cell bank, leaving customers without access to their cells. But in an email sent this week (January 25), Celltex reassured customers that their cells were safe and added that it will soon be offering treatments through doctors in Mexico. The email also said the company aims to begin an FDA-approved clinical trial in March 2013 to begin the approval process in the U.S., though because its culturing and banking technology was licensed from RNL Bio, there is some uncertainty about whether Celltex has the facilities and expertise to carry out the trial on its own.

April 2019

Will Car T Cells Smash Tumors?

New trials take the therapy beyond the blood

Marketplace

Sponsored Product Updates

Getting More Consistent Results by Knowing the Quality of Your Protein
Getting More Consistent Results by Knowing the Quality of Your Protein
Download this guide from NanoTemper to learn how to identify and evaluate the quality of your protein samples!
Myth Busting: The Best Way to Use Pure Water in the Lab
Myth Busting: The Best Way to Use Pure Water in the Lab
Download this white paper from ELGA LabWater to learn about the role of pure water in the laboratory and the advantages of in-house water purification!
Shimadzu's New Nexera UHPLC Series with AI and IoT Enhancements Sets Industry Standard for Intelligence, Efficiency and Design
Shimadzu's New Nexera UHPLC Series with AI and IoT Enhancements Sets Industry Standard for Intelligence, Efficiency and Design
Shimadzu Corporation announces the release of the Nexera Ultra High-Performance Liquid Chromatograph series, incorporating artificial intelligence as Analytical Intelligence, allowing systems to detect and resolve issues automatically. The Nexera series makes lab management simple by integrating IoT and device networking, enabling users to easily review instrument status, optimize resource allocation, and achieve higher throughput.
IDT lowers genomic barriers with powerful rhAmpSeq™ targeted sequencing system
IDT lowers genomic barriers with powerful rhAmpSeq™ targeted sequencing system
Increasing accuracy and reducing cost barriers, IDT’s innovative system delivers simple and cost-effective amplicon sequencing