Rejuvenate Stem Cell Center Cautioned on Umbilical Stem Cells

The CBER Office of Compliance and Biologics Quality says the Ramos Chiropractic and Wellness Center, Burlington, CO, which does business as Rejuvenate Stem Cell Center, markets through its Web sites “umbilical stem cells” from BioGenix for various diseases or conditions. A 5/4 Notice of Violation says the company’s products appear to be human cells, tissues, or cellular or tissue-based products that are subject to FDA regulation as drugs and biologic products.

“Your products are intended to treat a variety of diseases or conditions, including some that are serious or life-threatening,” the letter says. “Such unapproved uses raise potential significant safety concerns. Moreover, because the products may be administered by a higher risk route of administration, including by injection and intravenously, their use, if contaminated, could cause a range of adverse events.”

Rejuvenate was told to respond within 30 days.