Aspen Institute Cell Products Illegal: FDA

An FDA review of a Web site and YouTube channel maintained by Aspen Institute for Regenerative Medicine and Anti-Aging determined that the firm markets cellular products derived from umbilical cord blood or adipose tissue to treat diseases or conditions such as congestive heart failure, ischemia, chronic obstructive pulmonary disease (COPD), diabetes, multiple sclerosis, lupus, fibromyalgia, and irritable bowel syndrome. A 12/16/21 Notice of Violation says such cellular products are regulated as drugs and biologic products and require a valid BLA or IND, which Aspen does not have.

The letter also notes that Aspen markets exosomes for COPD, preterm brain injury, liver injury, and various types of cancer. It says that exosomes generally intended to treat diseases or conditions in humans also are regulated as drugs and biological products subject to premarket review and approval requirements.

The firm was told to respond within 30 days.