Exosomes are currently not approved by the FDA for cosmetic use and are therefore not regulated for now. Research on the use of exosomes is at the forefront of aesthetic medicine, in addition to the numerous uses of exosomes in general medicine.
Exosome products are also
regulated by the FDA. In general, exosome products intended to treat diseases or conditions in humans require approval from the FDA.There are currently no FDA-approved exosome products. In short, exosome-based therapies are a dynamic and growing area of research that has the potential to revolutionize multiple areas of medicine, including drug delivery, regenerative therapies, and diagnostic techniques. The function of exosomes is totally dependent on the source of the donor cells and can be constructive or destructive. Exosome research in regenerative medicine, especially in the context of incubated cell preparations, is promising as a disease-modifying therapy in the treatment of orthopedic conditions.
However, it's important to remember that exosome therapies are not currently approved by the FDA and their use should be limited to research protocols or FDA biological product licensing applications. More research, standardization and economies of scale are needed before exosomes are ready for widespread adoption. Some clinics across the country, including some that manufacture or market products with incompatible “stem cells”, now also offer products with exosomes to patients. They mislead patients with unfounded claims about the potential of these products to prevent, treat, or cure various diseases or conditions.
They may claim that these products are not subject to regulatory provisions for drugs and biological products, which is simply not true. In general, 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 pre-market review and approval requirements. Therefore, a regulatory approach to cell therapy may not be suitable for exosome therapy because the efficacy of exosomes produced by the same cells under different conditions may differ. As a result of the development of genetically engineered exosomes, it is now possible to evaluate the quality and purity of exosome-based drugs using current quality control measures based on good manufacturing practices (GMP), such as particle size and quantity tests.
Exosome products contain no cells and are hypoimmunogenic due to the lack of surface markers for MHC-II and low expression of MHC-I (compared to cells from their parents). The FDA wants to help consumers be informed about how these products are regulated and what they should consider when considering treatment with one of these products. Because of their inherent instability, liquid-based exosomes are highly susceptible to degradation and alteration within a few hours after production, either naturally or through engineering processes. Recent studies have shown that exosomes derived from mesenchymal stem cells (MSCs), which are extracted from human tissues, such as the endometrium, bone marrow and adipose tissue, have varying therapeutic effects.
More comprehensive quality monitoring must also be performed to identify the complex exosome content and the limitations of current testing methods. Given the complexity of exosomes, analyzing global regulatory frameworks, production techniques, and existing guidelines for biopharmaceuticals could help establish clearer rules governing exosomes. Transmission electron micrograph of a B cell transformed by the Epstein-Barr virus showing freshly exosomes exosomes exosomes in the plasma membrane. The analysis of active substances is vital to define appropriate strategies for control the quality of exosomes.
Exosomes and other regenerative medicine products are also advertised for many other conditions, but are not approved for such uses. Advanced analytical techniques can be used to effectively evaluate the composition and purity of exosomes in the future, which could lead to clearer regulatory oversight, similar to that of biological products. Practical checklists are included in the guidelines for researchers and clinicians, including the quantification and characterization of exosomes. For example, it has been shown that bone marrow stem cell exosomes can be as beneficial as the cellular components themselves in improving cartilage and nerve function.
The FDA is raising public awareness of reports of treatments not approved by the FDA with exosome therapies that can cause serious adverse drug effects. When exosomes are used as therapeutic agents, these should be governed in a manner similar to biological drugs.
