What Certified Provider Status Means

Practitioners listed in the 3DMSCS provider directory have completed our education program covering MSC biology, exosome cargo science, xenofree manufacturing standards, passage-number disclosure requirements, characterization criteria, and the regulatory landscape for EV-based preparations. They have demonstrated the ability to explain the science of the preparation they carry at the molecular level.

What you can expect from a certified provider: A certified practitioner can explain the difference between 3D and 2D culture, articulate why passage number matters, describe what xenofree media means and why it matters for batch consistency, and provide lot-specific COA documentation for the preparation used in their practice.

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What to Ask Your Provider

Informed patients are better advocates for their own care. Before any consultation involving an exosome preparation, consider asking your provider these six questions:

1

What is the passage number of the MSCs used to produce this preparation?

Accept P2-P4. Question P5+. If the provider cannot answer or the supplier does not disclose this, that is material information about the preparation's relationship to the published MSC literature.

2

Was this produced in 3D spheroid culture or 2D monolayer?

3D spheroid culture produces 3-5x more EVs per cell and significantly upregulated anti-inflammatory secretome cargo. 2D monolayer is the conventional, lower-activity standard. These are not equivalent preparations at the same particle count.

3

Is the manufacturing process xenofree throughout?

FBS-based media introduces thousands of bovine proteins and bovine EVs that contaminate the final preparation and prevent batch-to-batch consistency. Xenofree means no animal-derived components at any stage, not just the final collection step.

4

Can you provide a lot-specific COA?

A Certificate of Analysis specific to the lot being used should include NTA particle count with size distribution, CD9/CD63/CD81 tetraspanin confirmation, sterility (USP 71), endotoxin (LAL test result and acceptance criterion), and mycoplasma (PCR negative).

5

What is the tissue source of the MSCs?

Human umbilical cord tissue (Wharton's jelly) is the preferred source for combining youth of passage at isolation with consistent donor characteristics. Other sources including bone marrow and adipose tissue are used, each with different passage histories and isolation considerations.

6

How is this preparation stored and what is its stability data?

Exosome preparations require specific cold chain handling. The provider should be able to specify storage temperature, freeze-thaw cycle limitations, and stability data supporting the stated shelf life. These are quality indicators that reflect manufacturing rigor.

Are You a Practitioner?

Apply for certification to be listed in our provider directory and gain access to the product, the referral network, and the continuing education program.

Important regulatory notice: Extracellular vesicle and exosome preparations are not FDA-approved treatments for any disease or condition. Provider listings in this directory indicate completion of our education program — they do not constitute medical endorsement, treatment recommendation, or regulatory approval of any clinical protocol. Clinical decisions regarding exosome preparations should be made by licensed practitioners acting within their scope of licensure and in compliance with applicable state and federal regulations. Patients should consult their treating physician before initiating any regenerative medicine protocol.