U.S. Attorneys filed a civil complaint in the Central District of California against California Stem Cell Treatment Center Inc., of Rancho Mirage and Beverly Hills, California, Cell Surgical Network Corporation, and company owners Elliot Lander, M.D. and Mark Berman, M.D.

A companion case was filed in the Southern District of Florida, against US Stem Cell Clinic LLC, of Sunrise, Florida, US Stem Cell, Inc., and company officers Kristin Comella and Theodore Gradel.

Both complaints allege that the respective defendants manufacture “stromal vascular fraction” (SVF) products from patient adipose (fat) tissue, which the companies then market as stem cell-based treatments for a host of serious conditions and diseases, including cancer, pulmonary disease, arthritis, stroke, ALS, and multiple sclerosis, in the case of the California defendants; and Parkinson’s disease, spinal cord injuries, stroke, pulmonary disease, and traumatic brain injury, in the case of the Florida defendants.

According to the complaints, both sets of defendants manufacture their products for these conditions without FDA approval and without proof of safety and efficacy. The Justice Department filed the complaints at the request of the U.S. Food and Drug Administration (FDA).

“Marketing unproven and potentially unsafe treatments puts consumers at risk,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “The Department of Justice will continue to work with the FDA to make sure manufacturers of experimental therapies conduct their research within the safe and legal bounds for drug innovation.”

According to the complaints, the defendants and their affiliates have used their products on thousands of patients without first obtaining necessary FDA approvals.

The complaints allege that that in some cases, adverse events that harmed patients occurred after treatment with the SVF products.

In addition, the complaints allege that the defendants’ misbranded products fail to include adequate directions for use, such as dosages, warnings, and side effects.

According to the complaints, recent FDA inspections showed that the defendants’ products are not manufactured, processed, packed, or held in conformance with current good manufacturing practice (CGMP), and they are adulterated as a matter of law.

Berman responded that the FDA has long known about his clinics’ same-day treatments, which he said have shown overwhelmingly positive results. “We disagree with the mischaracterization that these treatments are dangerous,” Berman said. “All we’re doing is taking advantage of the cells in your own body. We’ve always been transparent with what we do.”

Berman and Lander control the operations of about 100 for-profit affiliate clinics, including the California Stem Cell Treatment Center and Cell Surgical, which market treatments that have not been proven safe, the DOJ alleges in the complaint.

But “Your stem cells are not a drug,” Berman said. “They’re your own property. We’re not manufacturing a drug.” Berman contends that his treatments are innovative and highly successful. For example, he said, of 2,400 patients suffering from knee osteoarthritis, 82 percent have shown positive results after stem cell therapy.

The California matter is being handled by Trial Attorney Natalie N. Sanders of the Civil Division’s Consumer Protection Branch, with the assistance of the U.S. Attorney’s Office for the Central District of California and Associate Chief Counsel for Enforcement Michael Shane of the U.S. Department of Health and Human Services’ Office of General Counsel.