FDA Cracks Down on Stem Cell Clinics

Federal prosecutors in California and Florida filed injunctions on Wednesday to stop two companies from providing stem cell treatments, alleging the clinics marketed their procedures as remedies for ailments including cancer and heart disease without proof of safety and efficacy, according to this statement from the Food and Drug Administration.

The firms put consumers at risk by promising benefits from treatments and products never approved by the FDA, the Justice Department alleged in court filings in both states.

The filings target two companies, one of which is affiliated with Innovations Stem Cell Center of Dallas.

At his clinic, Dr. Bill Johnson uses adult stem cells to treat patients. According to Johnson’s website, Innovations Stem Cell Center obtains adult stem cells from the adipose fat tissue of a patient. The cells are reintroduced into the body intravenously either through an IV or an injection.

“A lot of times, what you are doing in medicine is managing illness and this is the first time, for most of what I can see, that we actually have the tools that can go and do some real healing,” Johnson tells NBC 5.

But now, the FDA is filing a lawsuit to stop these kinds of stem cell therapies.

The FDA says they're not approved because they haven't been proven to be safe and effective.

In court papers, the FDA claims the companies that created the treatment, including the company with whom Johnson is affiliated, are falsely marketing to patients and potentially putting them at risk.

Dr. Sean Morrison at the Children's Research Institute at UT Southwestern says it’s good that the FDA is finally cracking down on these clinics.

Morrison is the past president of the International Society for Stem Cell Research.

“We are very exited about the promise of stem cell research but it takes many years of research to develop actual therapies and to figure out how to deliver them safely and effectively," Morrison said. "These companies try to short circuit that process by selling therapies to patients that haven't been tested."

The companies claim their treatments have been independently tested and since stem cells are not considered drugs, the FDA doesn’t have jurisdiction over its treatments.

“This is a surgery and the FDA has no regulatory power over surgeries," Johnson said. "They never have."

He says the clinics mentioned in the lawsuit are prepared to go to court.

The Cell Surgical Network released the following statement regarding the lawsuit:

The Cell Surgical Network (CSN) intends to vigorously defend the lawsuit filed today by the U.S. Department of Justice on behalf of the U.S. Food and Drug Administration. CSN strongly rejects the idea that a person’s own cells should be regulated by FDA as a drug. On behalf of all Americans, we look forward to protecting patients’ rights and the physician-patient relationship. We share FDA’s concern for patient safety, but do not believe that FDA regulation of a surgical procedure that simply harnesses the healing power of a patient’s own cells, without altering the biological characteristics of those cells, is the answer. The decision of whether or not the surgical procedure is performed should be made by the patient and physician – not the FDA or any other arm of the federal government.

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