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FDA Seizes Risky Smallpox Vaccine From San Diego Stem Cell Company

This image was captured from StemImmune's Facebook page on Aug. 28, 2017.

Credit: StemImmune Inc.

Above: This image was captured from StemImmune's Facebook page on Aug. 28, 2017.

The agency said it is looking into how StemImmune obtained the potentially dangerous vaccine for use in treatments given to cancer patients in Rancho Mirage and Beverly Hills.

A San Diego company has been using a risky smallpox vaccine as part of "unapproved and potentially dangerous" stem cell treatments, according to the U.S. Food and Drug Administration.

The FDA said on Monday it has seized five vials of the vaccine belonging to San Diego-based StemImmune Inc.

The vaccine is not commercially available, and the agency said it is looking into how StemImmune obtained it for use in treatments given to cancer patients at California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills.

The FDA announced the move on the same day it posted a warning letter to a Florida stem cell company and issued a statement from commissioner Scott Gottlieb saying the agency is stepping up enforcement against "dishonest actors" in the growing stem cell treatment industry.

Gottlieb is quoted as saying, "I've directed the agency to vigorously investigate these kinds of unscrupulous clinics using the full range of our tools, be it regulatory enforcement or criminal investigations."

Many stem cell scientists have for years been calling for tougher action against companies selling expensive and unproven treatments.

UC Davis scientist Paul Knoepfler said the FDA's actions represent a "positive step toward addressing the major, long-standing problem of stem cell clinics across the U.S. selling unapproved and risky 'therapies' to patients."

Knoepfler — who co-authored a 2016 study that found hundreds of clinics proliferating across the country — went on to say he hopes the FDA will take further action against other clinics.

"In short, today is a good starting point for the FDA, but it's just one step of many needed," he said.

Recent FDA inspections of StemImmune and California Stem Cell Treatment Centers found that vaccines containing live vaccinia virus were being used to create an unapproved stem cell product that was then injected into cancer patients intravenously and directly into their tumors.

According to the FDA, this vaccine had the potential to harm the hearts of these patients. The FDA also said the live vaccinia virus can cause serious, possibly life-threatening health problems in unvaccinated people accidentally exposed to it through close contact with someone who recently received the vaccine.

FDA commissioner Gottlieb had strong words to describe the kinds of treatments created by companies like StemImmune. In a press release, he said:

Speaking as a cancer survivor, I know all too well the fear and anxiety the diagnosis of cancer can have on a patient and their loved ones and how tempting it can be to believe the audacious but ultimately hollow claims made by these kinds of unscrupulous clinics or others selling so-called cures. The FDA will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work. I especially won't allow cases such as this one to go unchallenged, where we have good medical reasons to believe these purported treatments can actually harm patients and make their conditions worse.

Jeanne Loring, a stem cell scientist at the Scripps Research Institute in La Jolla, applauded the FDA's actions and Gottlieb's statement.

"I liked the fact that he clearly laid out what the FDA's strategy is," she said, "even if it isn't detailed enough for me to tell who is going to fall under it and who isn't."

Loring said she is waiting to see if the FDA will also crack down on other stem cell companies selling more common, yet still unproven treatments. She said in StemImmune's case, "These people made it very easy for the FDA to go after them."

StemImmune spokeswoman Ulrike Szalay emailed KPBS a statement saying the company is "fully cooperating with the FDA about the development of its stem cell-based investigational cancer therapy."

She wrote, "We look forward to continuing our dialogue with the FDA as we seek to bring this important cancer therapy to cancer patients."

StemImmune's website claims the company is "revolutionizing cancer treatment" by developing immunotherapies delivered as part of treatments using a patient's own stem cells.


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