Frequently Asked Questions About Exosomes

Exosomes are microscopic extracellular vesicles (30–150 nanometers) released by cells as part of cellular communication. They carry vital biological signals — such as proteins, lipids, mRNA, miRNA, cytokines, and growth factors — that influence the behavior of nearby or distant cells. In regenerative medicine, exosomes are used to promote healing, reduce inflammation, and stimulate tissue regeneration.

No. While they come from stem cells, exosomes are not living cells themselves. They are secreted by cells and act as messengers, carrying instructions that tell other cells how to behave — such as reducing inflammation or triggering tissue repair. Unlike stem cells, exosomes do not replicate and therefore pose no risk of tumor formation or immune rejection.

In medical use, the highest-quality exosomes are typically harvested from Wharton's jelly (a gelatinous substance in the umbilical cord) of healthy, full-term donated births. These exosomes are rich in growth factors and have no age-related degradation. Other sources include bone marrow and adipose (fat) tissue, but these may carry donor variability and lower regenerative potency.

When properly sourced and tested, yes. Exosomes like those used at ExoWellness are:

• Derived from screened, healthy donors
• Manufactured in sterile ISO 5 clean room environments
• Tested for sterility, potency, and viral clearance through third-party labs

They are free of DNA and unable to replicate, which minimizes risks commonly associated with cell-based therapies.

Exosomes promote:

• Collagen production and skin rejuvenation
• Hair follicle stimulation and regeneration
• Joint and soft tissue repair
• Nervous system modulation (for brain fog, fatigue, cognitive clarity)
• Systemic inflammation reduction (especially when used IV)

Results vary based on the area treated and the individual's condition, but many patients experience accelerated healing and improved tissue function.

It depends on the application:

• Aesthetics: Applied topically or injected after microneedling, RF, or laser treatments
• Hair restoration: Injected into the scalp
• Orthopedics: Injected into joints, tendons, or discs
• Systemic wellness: Delivered via intravenous (IV) infusion
• Neurological support: Administered through nebulization for brain-related symptoms

• PRP (Platelet-Rich Plasma) is made from your own blood and contains growth factors, but its quality is limited by your age and health. It can also be acidic, causing inflammation or burning on injection.
• Exosomes contain hundreds more regenerative factors, are non-inflammatory, and are more consistent in quality and potency.

Exosomes are currently classified as a 351 biological drug under FDA regulatory code 21 CFR 1271.10. That means they are regulated more strictly than amniotic or PRP products, and cannot be marketed with therapeutic claims unless they have an approved Biologics License Application (BLA) or are used under an active IND (investigational new drug application). Clinics offering exosomes must do so under compliance guidelines — which we adhere to strictly.

In most cases, no — not yet. However, some procedures involving disc injections using exosomes and fibrin (for spine-related degeneration) are covered by the VA for qualifying veterans. Widespread insurance coverage is expected in the coming years as more clinical trials are completed.

That depends on the treatment area and your body's response. For skin and aesthetics, results can last several months to over a year. In pain and joint applications, many patients experience long-term relief after a single treatment. For IV or neurological applications, some people do quarterly or biannual maintenance infusions.

Some patients notice improvements in inflammation, skin texture, or energy within days. Others may take several weeks as the regenerative process unfolds. For hair restoration, visible results typically take 2–3 months as new follicles enter the growth phase.

People with active cancer, autoimmune disorders, or infections should consult a physician before receiving exosomes. Pregnant or breastfeeding individuals are generally excluded. You should also avoid exosome therapy if you're allergic to any excipients or preservatives in the product formulation.

High-quality exosomes are shipped frozen on dry ice and must be stored at ultra-low temperatures to preserve potency. Once thawed, the product must be used within a limited window (usually 2–4 hours) and cannot be refrozen.

It varies. Some people benefit from a single treatment, while others may require a series depending on the severity of the condition. In aesthetics or wellness, many clinics offer 3-treatment packages spaced a few weeks apart for optimal results.

Ask these questions:

• Are the exosomes cryopreserved or lyophilized? (Cryopreserved = more effective)
• Are they classified as a 351 biologic?
• Is the product manufactured in an ISO 5 clean room?
• Is third-party testing performed for potency, sterility, and viral clearance?
• Do they provide a Certificate of Analysis (COA)?

If the answer to these is yes, you're in good hands.