WHAT ARE MSC EXOSOMES ?

Exosomes are nano-sized extracellular vesicles naturally secreted by mesenchymal stem cells (MSCs). They contain a variety of signaling molecules, including cytokines, growth factors, and mRNA, which are being actively researched for their potential roles in intercellular communication and regenerative applications.

Unlike live stem cells, exosome products do not contain DNA or replicate, and they are considered cell-free. Our manufacture produces its exosome product under strict quality and safety standards in accordance with current Good Manufacturing Practices (cGMP). Our team has over 20 years of experience in regenerative biologics and is dedicated to supporting the responsible development of investigational products under applicable FDA regulatory frameworks.

The FDA currently regulates the clinical use of stem cells and other human cells and tissue-based products (HCT/Ps) under specific criteria, including the requirement that autologous cells must be minimally manipulated and used for homologous purposes. Exosome-based products, as biologics, are being evaluated through established regulatory pathways and are not approved for clinical use unless part of an authorized clinical trial or under an approved IND or BLA.

As individuals age, the biological function of their stem cells changes, which is an area of active scientific investigation. Some researchers have explored younger tissue sources, such as placental tissue, for the collection of mesenchymal stem cells (MSCs) due to their ability to secrete a wide range of signaling molecules, including exosomes.

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Exosome production begins with carefully screened placental MSCs. These cells are expanded under controlled laboratory conditions that meet cGMP manufacturing standards. The cultured cells are stimulated to secrete exosomes into a conditioned medium, after which the exosomes are isolated, purified, and analyzed for consistency and quality. These exosome preparations are made available strictly for research use and are not approved by the FDA for clinical applications.

Our product contains a concentrated population of extracellular vesicles known as exosomes, which are naturally secreted by cells such as keratinocytes and fibroblasts. These vesicles carry a complex mixture of proteins, lipids, nucleic acids, and other signaling molecules. Exosomes are currently being studied for their role in intercellular communication and potential applications in skin biology and regenerative research.

XO REGEN exosome products are manufactured under Current Good Manufacturing Practice (cGMP) conditions to ensure consistency and quality. They are intended exclusively for research use and are not approved by the FDA for the treatment, diagnosis, or prevention of any disease or condition.

REGENERATIVE MEDICINE​

Exosomes have shown promise in regenerative medicine by promoting tissue repair and regeneration. They can influence cell proliferation, differentiation, and migration, making them potential candidates for enhancing the efficacy of regenerative therapies. Current Research on Exosomes in Regenerative Medicine