NativeMUSE™

- FDA 361 COMPLIANT

- HOMOLOGUS USE

- NO CULTURING

- VERIFIED MUSE CELLS

- ECM INTACT

- NON-TUMORIGENIC

The NativeMUSE™ Difference

No Culture. No Compromise.

NativeMUSE™ is built on a single principle: the best version of a MUSE cell is the one that was never altered.

It is the first FDA 361 Compliant MUSE Stem Cell Product in the USA. Available in ALL 50 States!

Minimally Manipulated

NativeMUSE™ is processed without culturing, expansion, or passage. The cells are isolated directly from Wharton’s jelly under cGMP conditions and cryopreserved, preserving the native phenotype and biological activity of the original tissue.

Non-Tumorigenic by Nature

MUSE cells do not require genetic reprogramming or forced pluripotency induction. Their pluripotent-like capacity is intrinsic — making NativeMUSE™ a biologically safe pluripotent cell source with no teratoma risk documented in published research.

cGMP Manufactured

Every vial of NativeMUSE™ is processed in our cGMP-compliant Arizona facility, released against full QC criteria, and accompanied by a certificate of analysis. Chain-of-custody documentation is available for every unit.

Lorem ipsm Dolor Sit Amet

Duis aute irure dolor in reprehenderit in voluptate velit ani esse cillum dolore eu fugiat nulla pariatur.Duis aute irure dolor in reprehenderit in voluptate velit ani esse cillum dolore eu fugiat nulla pariatur.

The first USA MUSE Stem Cell Product that is an FDA 361 Compliant HCTP for use in all 50 states. Made in the USA as Minimal Manipulation for Homologous Use. Patients are asking for MUSE, and now you can confidently offer compliantly!

What Is a MUSE Cell?

A Stem Cell Found in Nature. Preserved by Design.

MUSE cells — Multilineage Differentiating Stress Enduring cells — are a naturally occurring population of pluripotent-like stem cells residing within the stromal fraction of Wharton’s jelly in the umbilical cord. They are identified by co-expression of SSEA-3, a stage-specific embryonic antigen associated with pluripotency, and CD105, a mesenchymal marker.

What sets MUSE cells apart from other stem cell populations:

Pluripotent-Like Without the Risk

MUSE cells can differentiate into cells representative of all three germ layers — ectoderm, mesoderm, and endoderm — without forming teratomas. This distinguishes them fundamentally from iPSCs and embryonic stem cells, which carry tumor formation risk that has limited their clinical translation.

Stress-Responsive Homing

MUSE cells preferentially migrate to sites of tissue damage in response to sphingosine-1-phosphate (S1P) and other stress signals, suggesting a natural role in tissue repair that positions them well for regenerative applications.

Immune Privilege

Like other Wharton’s jelly-derived cells, MUSE cells express low levels of MHC class II and co-stimulatory molecules, supporting allogeneic use without HLA matching in many settings.

The Problem with Conventional MSC Products

Most Stem Cell Products Are Not What They Started As.

The majority of Wharton’s jelly and bone marrow MSC products on the market today are expanded in culture. They pass through multiple generations, adapted to plastic surfaces, fed with media, and selected for cells that grow well in a dish — not necessarily cells that perform best in the body.

By the time a cultured MSC product reaches the clinic, it may bear little resemblance to the cell population it originated from. Passage-induced senescence, phenotypic drift, and culture-acquired changes can alter surface marker expression, secretome profile, and differentiation potential in ways that are difficult to characterize and harder to control.

NativeMUSE™ takes a different approach entirely.

Product Specifications

NativeMUSE™ Product Profile

SOURCE TISSUE

Human umbilical cord Wharton’s jelly, full-term donation

CELL POPULATION

MUSE cells (SSEA-3+/CD105+) within stromal fraction

PROCESSING METHOD

Minimal manipulation — no culturing, no expansion

Documentation

Certificate of Analysis, chain-of-custody, handling protocol

CRYOPRESERVATIVE

Proprietary non-DMSO cryoprotectant

STORAGE

−86°C; do not refreeze

STERILITY

USP sterility tested per unit

Regulatory Classification

Minimally manipulated HCT/P per 21 CFR Part 1271

Ready to Add NativeMUSE™ to Your Practice?

Our team is ready to walk you through product documentation, regulatory support materials, and distribution terms. Reach out to begin the qualification process.

Regulatory Positioning

Designed for Compliance from Day One.

NativeMUSE™ is processed as a minimally manipulated human cellular and tissue-based product (HCT/P) under 21 CFR Part 1271, which governs the recovery, processing, storage, labeling, and distribution of human cells and tissues. Under this framework, products that meet minimal manipulation and homologous use criteria do not require IND or BLA approval for clinical application by licensed providers.

Every element of NativeMUSE™ processing is designed with this regulatory classification in mind — from donor screening and tissue recovery through cGMP processing, release testing, and distribution. Full regulatory documentation is provided to qualified distribution partners upon execution of a distribution agreement.

Ordering & Distribution

Who Can Order NativeMUSE™?

Licensed healthcare providers operating within applicable state and federal regulations
Regenerative medicine clinics with appropriate tissue handling capabilities
Research institutions and IRB-approved investigational programs
Qualified distribution partners with cold chain logistics capability