Smallpox vaccine seized at stem cell clinic, FDA cracking down

U.S. Marshals recently seized five vials of a smallpox vaccine that a California stem cell company was using in an unapproved and risky procedure, the FDA has announced.

Promising to crack down on unscrupulous practices, the FDA also issued a warning to a Florida stem cell clinic performing what it said were similarly dangerous procedures.

In the California case, StemImmune in San Diego possessed the vials of vaccinia virus vaccine, which was administered to patients with cancer at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, an FDA release stated.

Each vial contained 100 doses, and one vial was “partially used,” the agency said, without specifying how many doses were administered.

The vaccinia virus vaccine is reserved for people deemed at high risk for contracting smallpox, like some military personnel. It is not commercially available and can cause potentially life-threatening illness in people who contract the vaccinia virus through close contact with a patient who received the vaccine. FDA officials said they are investigating how StemImmune obtained the vaccine.

FDA Commissioner Scott Gottlieb, MD, said his agency is determined to reign in stem cell therapy providers who mislead and endanger patients.

“Speaking as a cancer survivor, I know all too well the fear and anxiety the diagnosis of cancer can have on a patient and loved ones, and how tempting it can be to believe the audacious and ultimately hollow claims made by these kinds of unscrupulous clinics or others selling so-called cures,” Gottlieb said in the release. “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.”

The StemImmune vials were seized after FDA inspectors said they confirmed that amounts of the vaccine were being combined with stem cells from body fat. The mixture was injected intravenously or directly into tumors, according to the release.

FDA spokeswoman Lyndsay Meyer told Infectious Disease News that the agency had not received any reports of adverse effects through its MedWatch adverse event reporting program.

“However, given that this is an unapproved product, it is unlikely that any adverse events would have been reported to the agency,” she added.

Meyer said regulations prohibit her from saying whether the FDA has previously encountered the unapproved use of the vaccinia virus vaccine. However, anyone who knows of its unapproved use is urged to report it to MedWatch.

A statement issued by StemImmune said company officials are addressing the FDA allegations.

“StemImmune … is fully cooperating with the FDA about the development and use of its stem cell-based investigational cancer therapy,” the statement said. “Our primary concern has been and continues to be the safety and well-being of patients in clinical trials and compassionate use programs. At this time, we are working to understand and address the questions raised by the FDA about the use of our therapy for cancer patients in individual compassionate use programs in clinics. As more information becomes available to us, we will update this statement.”

PAGE BREAK

In Florida, the U.S. Stem Cell Clinic in Sunrise also administered stem cells from body fat to patients, according to a second FDA release. The FDA issued a warning to the clinic for allegedly marketing stem cell products without approval and for unsound manufacturing practices that in part compromised product sterility.

FDA inspectors reported finding that the clinicians there had been injecting the stem cells intravenously or directly into patients’ spinal cords. The injections targeted serious conditions like Parkinson’s disease, ALS, COPD, heart disease and others, they alleged.

The inspectors also reported finding “evidence of significant deviations from current good manufacturing practices in the manufacture of at least 256 lots of stem cell products by the clinic,” the FDA release said.

“U.S. Stem Cell Clinic also tried to impede the FDA’s investigation during the most recent inspection by refusing to allow entry except by appointment and by denying FDA investigators access to employees,” the agency continued.

The FDA requested a response to the warning within 15 working days. Should the clinic fail to do so, it could face seizure, injunction or prosecution.

The clinic issued a statement that in part appears to dispute the allegation that inspectors were impeded.

“The safety and health of our patients are our number one priority and the strict standards that we have in place follow the laws of the Food and Drug Administration,” it said. “Since November 2014, we have offered the FDA unrestricted access to our facilities and our processes and will continue to work with them as it pertains to clinical and industry improvements … We have helped thousands of patients harness their own healing potential. It would be a mistake to limit these therapies from patients who need them when we are adhering to top industry standards.”

It was unclear whether clinic officials were denying that the body fat stem cell injections took place or that they are dangerous. The clinic said it would reply to the FDA warning within the allotted 15 working days.

The FDA is urging health care providers and consumers to report any adverse events associated with treatments at either the U.S. Stem Cell Clinic or the California Stem Cell Treatment Centers to MedWatch.

A completed form can also be sent by fax to 1-800-FDA-0178. – by Joe Green

Disclosure: Meyer is a spokeswoman for the FDA.

Editor’s note: This article was updated on Tuesday, Aug. 30, with a statement from StemImmune.