Each country has its own regulations on cosmetic ingredients and, in some countries, it's not illegal to use exosomes of human origin. In the EU and the UK, exosomes of human origin are not approved for cosmetic applications and should not be used in aesthetic practice. As a result, the use of exosomes of human origin in cosmetic treatments remains banned in both the EU and the UK under current regulations. Taking into account the complexity of exosomes, analyze global regulatory frameworks, production techniques and current guidelines for biopharmaceutical products could help establish clearer rules governing exosomes.
Exosome treatments are an innovative approach to skin care that promotes youth by stimulating collagen production and improving cell renewal. Excellent treatment, I love the results of microneedled exosomes as a dual treatment protocol. This faster process results in a final product that is HOMOGENEOUS and PURE with up to 10,000 times more exosomes per unit than other exosomes. Emerging therapeutic areas, such as gene therapy, cell therapy, exosomes and nucleic acid drugs, are being actively developed. Plant or fish cell exosomes “simply don't have the right language to communicate with human cells,” says Erin Crowley, who has experience in mechanical engineering and quality control.
People are spending thousands of dollars on unproven exosome therapies for hair loss, skin aging and acne, as well as on more serious illnesses such as prolonged Covid and Alzheimer's. In the U.S. In the U.S., exosomes are regulated as drugs and biological products when they are “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases” and “are intended to affect the structure of any function of the body of man or other animals,” according to the Food and Drug Administration, which regulates drugs in the U.S. UU.
The doctors tell me that applying exosomes after, for example, a puncture procedure will add 500 to 800 pounds to the bill. There are specific restrictions on the topical use of exosomes of human origin as a cosmetic product. Currently, quality control and production development in the field of exosomes are focused on monitoring particle size and numerical distribution, rather than content validation. In any case, there are no rigorous human studies to support the safety or efficacy of using exosomes for skin health, hair growth, or anything else. He is also concerned that, since exosomes may contain debris from the original cell, they could be introducing substances that recipient cells would prefer to get rid of.
The lack of official approval for injectable exosome products worldwide can be attributed to the variability and impurity of exosome preparations. The best way to take advantage of exosomes, says Dr. Tiryaki, is to use those extracted from donated young human tissues, where the power of regeneration it's very strong, and inject them.