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FDA seeks to shutter two stem-cell firms after patients are blinded

Washington

THE Food and Drug Administration (FDA) is asking federal courts on opposite sides of the country to permanently stop two stem-cell companies from operating, following reports of patients being blinded by their treatments.

In a statement announcing the request for the injunction on Wednesday, FDA said US Stem Cell Clinic in Florida, the Cell Surgical Network in California and others like them are exploiting patients desperate for cures and causing some of them "serious and permanent harm". The agency said both companies "have continued to disregard the law" and marketed products without regulatory approval.

Hundreds of such clinics have popped up across the country in recent years, many promoting treatments for conditions from Parkinson's disease to autism to multiple sclerosis. Federal regulators have not approved their procedures, and critics liken their practices to that of modern-day snake-oil salesmen.

Many stem-cell researchers and former patients have long urged the FDA to take stronger action against the clinics. Current and former agency officials have acknowledged the need for greater regulation of the booming industry, citing limited resources for the lack of aggressive action in the past.

Commissioner Scott Gottlieb said Wednesday: "It's important that we send a stronger deterrent message. If people are putting patients at risk and creating patient harm, we're going to take action." He noted that the injunction request is the latest in a series of moves the FDA has made in the past year, and that more are planned in coming months, including warning letters to other stem-cell clinics.

Mr Gottlieb said: "From my standpoint, this is a field where there's a lot of medical promise, but we also see bad actors putting people at risk, harming patients and peddling false hope."

The co-founder of Cell Surgical Network, the country's largest group of independent stem-cell clinics, called the FDA's court action "ridiculous".

Beverly Hills plastic surgeon Mark Berman said the treatments the network's 100 clinics provide should not count as drugs that require FDA regulation because they consist of stem cells derived from fat suctioned out of patients' own bodies.

"They would have to go out of way to claim that your own personal cells that are taken out of your own body are drugs," said the doctor, who said his company has retained several Washington-area lawyers and would appeal the injunction case all the way to the Supreme Court if necessary.

Dr Berman's partner, network co-founder Elliot Lander, said there were "a lot bigger issues at stake than our business. When we do these surgical procedures, we are giving patients access to healing cells in their own body. If it had to be approved as a drug product, it would take hundreds of millions dollars and years to achieve that."

US Stem Cell Clinic said in a statement that it plans to vigorously fight the injunction in court. The company's chief science officer Kristin Comella said: "My entire career has been dedicated to studying and developing treatments utilising the body's own natural ability to heal. I remain steadfast that no government agency should deprive individuals of their right to harness the cells that exist in their body."

If granted, the injunction against the two companies would stop all of their clinics from marketing stem-cell treatments without FDA approval. The FDA had issued warning letters to both companies last year, and in its new complaint to federal courts, the agency said both had ignored those letters and continued to operate and put patients at risk.

Each company has been sued by patients who sought treatment for deteriorating vision because of disease, but say they went blind after the clinics injected stem cells into their eyes.

One Florida woman suffering from macular degeneration, whose case was documented last month by The Washington Post, said a Cell Surgical Network clinic in Georgia suctioned fat from her belly and then injected the stem cells from that tissue into both her eyes. Within months, she went blind. WP

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