Provider Inquiry

This page is for licensed medical practices and regenerative medicine providers who want to learn about sourcing pharmaceutical-grade, three-dimensional MSC-derived extracellular vesicles for clinical application.

Product overview

The clinical extracellular vesicle preparation described here is derived from umbilical cord mesenchymal stem cells (UC-MSCs) cultured under three-dimensional conditions. The 3D culture environment is maintained in a pharmaceutical-grade, xeno-free bioreactor system that preserves cell-to-cell signalling geometry and paracrine output profiles consistent with the peer-reviewed 3D MSC literature.

Key product characteristics:

• 60 billion extracellular vesicles per vial (2 mL) — enumerated by nanoparticle tracking analysis (NTA).
• Derived from umbilical cord MSCs (Wharton's jelly), a well-characterised, ethically sourced starting material with established immunomodulatory and paracrine properties.
• 3D culture process — EVs are harvested from spheroid-conditioned media, not from 2D monolayer culture. Culture format is documented to affect EV cargo and yield (see research library).
• Pharmaceutical-grade manufacturing with lot-level QC: endotoxin, sterility, particle size distribution, and protein quantification per lot.
• Xeno-free formulation — no animal-derived serum in the final product.

Characterisation standards

Each lot is characterised to MISEV2023-aligned minimum standards for extracellular vesicle preparations. Documentation provided to authorised partners includes:

• NTA size distribution and concentration report.
• Western blot or flow cytometry confirmation of canonical EV surface markers (CD9, CD63, CD81, or equivalent).
• Absence of common contaminants (lipoprotein depletion steps documented).
• Certificate of Analysis (CoA) with endotoxin and sterility results.

Detailed characterisation methodology and representative lot data are available to prospective partners on request following qualification.

Regulatory posture

Extracellular vesicle preparations are regulated differently across jurisdictions. Prospective partners are responsible for understanding and complying with the regulatory requirements in their own jurisdiction — including FDA, EMA, Health Canada, TGA, PMDA, or applicable national authority guidelines — before any clinical application. No therapeutic claims are made or implied on this site. The product is not approved by the FDA for any indication; distribution and use are the responsibility of the receiving licensed practitioner.

Who this is for

The typical partner practice operates in one or more of the following clinical areas:

• Regenerative medicine and cellular therapy.
• Orthopaedic or musculoskeletal medicine.
• Integrative or functional medicine with a biologic focus.
• Research institutions or academic medical centres conducting pre-clinical or clinical investigations.

Applicants are required to hold a current medical licence and to provide verification of their practice and applicable accreditations during the qualification process.

How to apply

Provider qualification is a two-step process:

1. Initial inquiry. Submit the inquiry form below or send a request by email. Include your practice name, jurisdiction, licence number, and a brief description of the intended application context. A member of the team will respond within 3–5 business days.
2. Qualification review. Provide documentation (licence verification, practice profile, and jurisdiction-specific compliance confirmation). Upon approval, access to lot CoAs, pricing, and ordering is granted.

Inquiry form

To begin the qualification process, provide the following information. Fields marked * are required.

Submissions are reviewed manually. Approval is not automatic and is subject to licence verification and compliance assessment. No purchase commitment is implied by submitting an inquiry.

Additional resources