Amid Lawsuit, San Diego Stem Cell Company Pushes Back On Proposed Regulations

San Diego-based Stemgenex is asking regulators to let patients have access to stem cell treatments it calls "life-altering." But patients currently suing the company claim they were charged thousands of dollars for falsely advertised treatments that didn't improve their health.

In a press release issued last week, the La Jolla company outlined its argument against the U.S. Food and Drug Administration's proposed plans for regulating stem cell treatments. Stemgenex argues the proposed rules would treat a patient's own stem cells as a drug, subjecting stem cell therapies to a lengthy and expensive approval process.

Stemgenex's press release claims the rules, if finalized, "will delay access to stem cell therapies in the United States and cause many Americans who are struggling with degenerative disease to seek treatment outside of the county (sic)."

Jeanne Loring, a stem cell scientist at the Scripps Research Institute, spoke in favor of the proposed rules at an FDA meeting in September. Loring believes these kinds of stem cell clinics need regulation because in her opinion they are "selling something that doesn't work, for a very...