Pilargo Foundation™ Foundation

Authentication standard

A preparation is what was measured in it

Muse cells aren't manufactured from scratch — they're separated out of an ordinary cell culture. So the number that matters most for any batch is simple: what percentage of the cells in it actually test positive for the Muse marker, SSEA-3? Everything else on this page follows from that one figure.

The scale

Enrichment is visible, or it did not happen

In plain terms

Picture an unsorted cell culture as a jar of mixed beans with only a few rare gold beans mixed in. “Enrichment” means running the jar through a process that sorts out the gold beans and concentrates them. Skip that step, and the jar still has the same small handful of gold beans it started with — but nothing stops a supplier from writing “gold beans” on the label anyway. Counting the beans is the only way to tell the difference.

Selling a Muse preparation means selling one in which the SSEA-3-positive fraction has been deliberately concentrated well above what tissue naturally contains. If that fraction sits at background level, the material is — functionally and scientifically — a mesenchymal preparation carrying a Muse label.

That distinction is not a matter of opinion or of sourcing. It is a measurement, taken on an instrument, on a specific batch, at a stated passage number. Everything else on this page follows from that one figure.

A large wall-mounted display in a dark modern laboratory, showing a dense teal scatter plot with a rectangular gate isolating a sparse population in one corner.
Where the number comes from A gate drawn around a marker-positive population on a flow cytometer. The percentage of events inside that gate is the figure a Certificate of Analysis reports.

Where a preparation sits on the SSEA-3 scale

Published SSEA-3-positive percentages by preparation type. The distance between the left band and the right bands is the entire difference between an unsorted mesenchymal culture and an enriched Muse preparation.

1% 3% 10% 30% 100% Natural background of any unsorted culture Unsorted cord, earliest passage Enriched product after expansion Post-sort

Figures from the published literature: Leng et al., Cell Transplantation 2019;28(7):907–923; Foundational literature; Wakao et al., 2026 (canine 0.93%, feline 2.9%). Ranges vary with tissue source, sorting method and passage number.

Published benchmarks

What the literature reports

MaterialSSEA-3 positiveSource
Bone marrow mononuclear cells, naive0.025–0.05%Foundational literature
Canine adipose-derived stem cells0.93 ± 0.16%Wakao et al., 2026
Cultured mesenchymal cells, generally~1% to a few %Consensus across literature
Feline adipose-derived stem cells2.9 ± 0.15%Wakao et al., 2026
Umbilical cord, earliest passage5.0–5.3%Leng et al., 2019
Sorted, expanded to passages 6–942.0–54.7%Leng et al., 2019
Sorted, expanded to passages 2–562.5–76.0%Leng et al., 2019
Immediately after magnetic sorting91.4 ± 3.2%Leng et al., 2019

How to read this table

The top rows are measurements of what tissue naturally contains. The bottom rows are products. A figure in the low single digits has not been enriched — it has been measured. That distinction is the whole of the authentication question.

Manufacture

The sequence that produces a Muse preparation

Muse cells cannot be obtained by centrifuging tissue or by using a generic isolation kit. The steps below are what distinguish the product from the source material — and steps two and three are the ones that create it.

Step three is the one that costs money and the one that is easiest to skip. A preparation whose marker percentage sits at background level is evidence that it was either not performed or did not work.

A separation column in a precision aluminium mount, tubing running from its outlet, with a single droplet forming at the tip against a backlit teal panel.
The step that creates the product Column-based separation apparatus on the bench. Enrichment is a deliberate processing step, not a property of the source tissue.
  1. Tissue collection

    Starting material from adult bone marrow, fat tissue, umbilical cord, or a skin-derived cell culture.

  2. Stress-endurance selection

    Grow the culture under harsh conditions — no serum, low oxygen, or a long chemical soak — that ordinary cells don't survive but Muse cells do. This is the property the cells are named for, and it's the first filter.

  3. SSEA-3 enrichment

    Physically sort out the SSEA-3-marked cells with a lab instrument. This is the step that actually creates the product — skip it, and there's nothing to call "enriched."

  4. Molecular and functional validation

    Confirm the sorted cells behave like Muse cells: check for the right internal genes (OCT4, NANOG, TERT), show in a dish that they can turn into different cell types, and confirm they don't form tumours.

  5. Expansion

    Grow the sorted cells under controlled conditions to reach a usable quantity. They often cluster into small ball-shaped groups during this stage.

  6. Batch release testing

    A Certificate of Analysis for this specific batch — covering the SSEA-3 percentage, how many cells are alive, cell count, and sterility.

Certificate of analysis

What a batch document should contain

A blank ruled batch record form and a capped cryovial on dark polished stone, lit by a hard shaft of directional light.
A form is only worth the figures entered on it The fields below are what should be filled in, batch by batch, for the specific lot being shipped.

Think of this as a checklist. If a supplier's paperwork is missing more than one or two of these fields, that's worth asking about before you order.

FieldWhy it matters
SSEA-3 positive %The defining figure. Must be from this batch, not a reference lot or historical run.
Method and passageSSEA-3 declines across post-sort expansion, so a percentage is only interpretable alongside the passage number at which it was measured.
Enrichment stepWhether MACS or FACS sorting was performed, and documented.
ViabilityTypically assessed by dual staining. Distinguishes freeze-thaw injury from a culture that was already deteriorating.
Total and viable cell countShould reconcile with the labelled content, and state which of the two the label refers to.
Mesenchymal panelCD73, CD90, CD105 positive; haematopoietic markers low, against ISCT minimal criteria.
Pluripotency and differentiationOCT4, NANOG, TERT expression and trilineage capacity. See the caveat below.
Lot, date, chain of custodyLot number, date of manufacture and passage should be legible and should reconcile across vial, CoA and shipping documentation.

A caveat on the marker itself

SSEA-3 is the standard Muse marker, but it has been documented on some non-stem cells. A high percentage is therefore necessary but not sufficient to establish identity. Rigorous characterisation also requires pluripotency gene expression, demonstrated trilineage differentiation, and documented absence of teratoma formation. A certificate reporting SSEA-3 alone is better than nothing, but it is not a complete identity test.

For buyers

Questions worth asking any supplier, including us

01

What is the batch SSEA-3 percentage?

Request the Certificate of Analysis for the specific lot being shipped.

02

At what passage was it measured?

A percentage without a passage number cannot be compared to a published benchmark.

03

Was a sorting step performed?

MACS or FACS enrichment, documented. Without it, the vial holds source material.

04

What else was characterised?

Pluripotency gene expression and trilineage differentiation, beyond the marker alone.

05

Does the chain of custody reconcile?

Lot, date, passage and cell count should agree across every document.

06

Is the indication within the evidence?

Published human data exists for a specific short list. Applications outside it are extrapolations.

Pilargo Foundation™ is part of Rinnovare Labs™ — our parent company.