The field of regenerative medicine is ever expanding and evolving. As more viable options become available to patients, it’s important to stay abreast of regulation surrounding many of these applications.
In late 2019, the Food and Drug Administration (FDA) began informing the public of multiple reports of serious adverse events experienced by patients who were “treated” with non-FDA approved products marketed as containing exosomes. As a general matter, exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products under the Public Health Service Act and the Federal Food Drug and Cosmetic Act and are subject to premarket review and approval requirements. At the time of the 2019 warning, there were no FDA-approved exosome products and the FDA since then has not put out any new guidance.
More recently, HCT/Ps (Human Cells, Tissues and Cellular and Tissue-Based Products) such as stem cells are have been regulated by the FDA for many years and it has always been the law that unless operating pursuant to an investigational new drug application (IND) or the “same surgical procedure exception” (e.g., extracting bone marrow), such therapies are only permissible (1) if there is no more than minimal manipulation of the cells/tissue; and (2) for homologous use only.
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- Minimal manipulation is defined as:
- 1) For structural tissue, processing that does not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement; and
- 2) For cells or nonstructural tissues, processing that does not alter the relevant biological characteristics of cells or tissues.
- Minimal manipulation is defined as:
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- Homologous Use is defined as the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor.
Over the past few years FDA’s enforcement priorities in the regenerative medicine space have been primarily aimed at (1) the manufacturers/distributors of these products; (2) clinics that provide Stem Cell/Exosome therapies that result in patients being injured; and (3) those who make false/deceptive/misleading claims about the results these treatments/therapies can provide. Use of these products outside of the above stringent requirements has never been permissible under the eyes of the FDA; there has just been a policy of discretionary enforcement up until this year.
