DEPARTMENT OF JUSTICE FILES COMPLAINTS TO STOP USE OF (unapproved) EXPERIMENTAL STEM CELL DRUGS

[nitpicker]

https://www.justice.gov/usao-cdca/pr/department-justice-files-complaints-against-florida-and-california-companies-stop-use

Department of Justice
U.S. Attorney’s Office
Central District of California

FOR IMMEDIATE RELEASE
Wednesday, May 9, 2018

DEPARTMENT OF JUSTICE FILES COMPLAINTS AGAINST FLORIDA AND CALIFORNIA COMPANIES TO STOP USE OF EXPERIMENTAL STEM CELL DRUGS ON PATIENTS

WASHINGTON – The United States filed civil complaints in Florida and California to enjoin two companies that purport to offer stem cell treatments, the Justice Department announced today. The first complaint, filed May 9, 2018, in the Southern District of Florida, is against US Stem Cell Clinic LLC, of Sunrise, Florida, US Stem Cell, Inc., and company officers Kristin Comella and Theodore Gradel. A separate complaint was filed the same day 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.

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).
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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.
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[samnsara]

1. dog cancer will be cured before human cancer is!