Two Revolutionary FDA 361 Compliant Biologics
Dux Bio offers the first FDA 361 Compliant MUSE Stem Cell Product, NativeMUSE, now available in all 50 states. Also offering DuxCord, an FDA 361 compliant Umbilical Cord Blood Stem Cell Product!
MINIMAL MANIPULATION STEM CELL PRODUCTS
FDA 361 COMPLIANT
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!
An umbilical cord blood stem cell product that is FDA 361 Compliant, over 90% viable with a consistent 30 million cells per vial. Each vial purchased comes with a free exosome vial too!
FDA 361 COMPLIANT
NativeMUSE™
Minimal Manipulation
No cell expansion, no additives or enzymes, and the extracellular matrix is intact. Concentrated MUSE stem cells isolated with minimal manipulation.
Regulatory Clarity
Processed under 21 CFR Part 1271 HCT/P frameworks with documentation structured to support clinical use and
regulatory review.
cGMP Compliance
Full chain-of-custody documentation,
COA per lot, and AABB-compliant
donor screening for every
vial shipped.
The PERFECT Cord Blood Stem Cell Product
DUXCORD™
Non-DMSO Formula
Eliminates the cytotoxic risks and wash-out requirements associated with DMSO-based cryoprotectants — direct clinical use post-thaw.
Superior Viability
Greater than 90% post-thaw viability ensures the full therapeutic stem cell payload reaches patients in an
active, potent state.
99%+ RBC Depletion
Precision isolation removes >99% of red blood cells, delivering an ultra-pure stem cell preparation with minimized immunogenic burden.
30M
CB-MNC
CELLS PER VIAL
90%
POST-THAW
VIABILITY
>99%
RBC
DEPLETION
0%
DMSO IN
FORMULATION
cGMP
COMPLIANT
PROCESSING
Stem Cells at the Core
What makes Dux Cord clinically powerful
CD34+ Hematopoietic Stem Cells
The defining therapeutic fraction — capable of differentiation into multiple lineages and paracrine-driven tissue repair.
>99% RBC Depletion
Ultra-pure mononuclear preparation eliminates red blood cell contamination, reducing immunogenic load and improving tolerability.
MSC Co-Population
Mesenchymal stromal cells within the MNC fraction contribute immunomodulatory and trophic support to the stem cell payload.
Neonatal Immune Privilege
Cord blood-derived cells express lower HLA surface density than adult sources, enabling a more favorable allogeneic profile.
FAQ'S
Frequently asked Questions
What types of providers can purchase Dux Bio products?
Are Dux Bio products FDA-regulated?
What makes Dux Cord different from other cord blood products?
What is a MUSE stem cell and why does minimal manipulation matter?
How are Dux Bio products shipped and stored?
All products are cryopreserved and shipped on dry ice with validated cold chain packaging. Dux Cord is stored at -86°C and should not be refrozen once thawed. Detailed handling and thawing protocols are provided with every order.