EXOSOME ADVOCATE

Science-based education on exosomes for clinical decision-makers.

What this site does:

Clear, method-first education to help clinics evaluate exosome products without hype or unsupported claims.

WHY SOURCE MATTERS (hTSC vs MSC)

Most commercial discussions refer to MSC-derived material. Our education focuses on hTSC-derived exosomes. Cell source influences cargo and surface features; our proteomic and miRNA analyses show profiles that differ substantially from typical MSC exosomes. We explain those differences and how to interpret them—without implying clinical effects.

Source Traceability (what it is—and isn’t)

Traceability (documented cell origin, controls, chain of custody) is essential and expected in regulated cell therapy contexts. While many reputable manufacturers do this, some skip steps to cut cost and time. We show what proper documentation looks like and where gaps commonly appear.

Molecular Profile: Proteins & miRNA (not just markers)

Rather than centering on “exosome presence” markers alone (CD9, CD63, CD81), we emphasize comprehensive proteomic and miRNA content for product characterization. Detection methods for surface markers remain variable across labs. We use currently generally accepted characterization assays for cell and gene therapy products from reputable vendors. In addition to typical exosome markers, we have a large library of detailed data relating to protein and miRNA content. We anchor education in deeper protein/miRNA datasets.

Safety and lot-to-lot Consistency

Safety work belongs on every lot and should appear on the Certificate of Analysis. At minimum, release criteria must include:

Sterility
Mycoplasma
Endotoxin

Any injectable product lacking certificates for these three should be rejected.

Because our hTSC source can yield on the order of magnitude of 500 million-1 billion treatments from a single cell line, we willingly sacrifice product for expanded testing (including lot-to-lot protein analytics). This scale supports a stable manufacturing program projected to run consistently for 10+ years.

We also perform additional industry-standard assays required for cosmetic ingredient registration (e.g., eye and skin irrational panels) to further de-risk use contexts where applicable.

GET THE EXOSOME NEWSLETTER

PRACTICAL OVERVIEW OF EXOSOME FUNDAMENTALS, HTSC VS MSC DIFFERENCES, AND A VENDOR DUE-DILIGENCE CHECKLIST. EDUCATIONAL CONTENT ONLY. →

Bottom line: Transparent science builds trust. We state what the data supports and where it stops.

What current technology cannot prove

Identity at the single-particle level, absolute purity, and definitive functional readouts for complex exosome mixtures are not reliably established with today's commercial methods. Strong claims in these areas should be treated skeptically.

What we know–and don't

We know:

We do not know:

This site is educational. Exosome products are not FDA-approved to treat, cure, or prevent disease at this time. We don’t make therapeutic claims. We teach standards and the questions to ask any vendor—before you buy.