Bone Marrow Exosomes: Why Source Matters

Not all exosome products are created equal. The cell source they're derived from determines their protein composition and how consistent they are from batch to batch, which can directly impact how clinicians use them in practice. PBME Topical™ is manufactured using bone marrow-derived mesenchymal stem cell (MSC) exosomes, offering a well-characterized source designed for consistency and quality.

What Are Bone Marrow Exosomes?

Bone marrow exosomes are nanoscale extracellular vesicles, measuring approximately 30 to 150 nanometers, that are naturally released by cells to support cell-to-cell communication. These vesicles contain proteins, messenger RNA (mRNA), and microRNA (miRNA) that help transmit biological signals between cells and support the body's natural regenerative processes.


PBME Topical™ utilizes exosomes derived from bone marrow mesenchymal stem cells (MSCs), one of the most extensively researched cell sources in regenerative science.

Why Bone Marrow MSCs?

Bone marrow mesenchymal stem cells (MSCs) are among the most widely studied cell lines in the field of regenerative medicine, showcasing their significant potential for therapeutic applications. According to the provided research summary, there are more than 63,000 peer-reviewed publications available on PubMed that focus on bone marrow MSCs. In stark contrast, there are only about 1,200 publications that discuss various birth tissue sources, including placental and amniotic tissues combined. This striking disparity highlights the extensive research interest and established understanding of bone marrow MSCs within the scientific community.


Rather than relying on pooled birth tissue, which may introduce variability and inconsistencies, PBME Topical™ is meticulously manufactured from a single, consistent donor cell source. This carefully considered approach is intended to provide clinicians with a more predictable and well-characterized product, ensuring reliability and consistency from one lot to the next. Such precision in sourcing enhances the overall quality of the therapy, ultimately benefiting both practitioners and patients alike.

Why Future Medical Products

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Modulate Inflammation

Growth factors and exosomes work to shift the treatment environment from a chronic inflammatory state to one that supports healing and regeneration.

Reprogram and Protect Existing Cells

Regenerate New Tissue

mRNA and miRNA carried by the exosomes deliver signals that promote new tissue formation and support the body’s natural regenerative capacity.

Comprehensive Safety Profile

Every lot of PBME Topical™ undergoes a full communicable disease testing panel and quality verification:

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  • Human Origin Material: Fresh Human Bone Marrow Aspirate
  • Source Country: United States of America
  • HIV Type I & II: NONREACTIVE
  • Hepatitis B (HBV): NONREACTIVE
  • Hepatitis C (HCV): NONREACTIVE
  • Treponema pallidum: NONREACTIVE
  • HTLV-I & HTLV-II: NONREACTIVE
  • Cytomegalovirus: NEGATIVE
  • West Nile virus: NONREACTIVE
  • Zika virus: NEGATIVE
  • Trypanosoma cruzi: NONREACTIVE
  • Processed in ISO 14644-1 Level 7 Cleanroom: PASSED
  • Particle Size (30–150nm): 70nm ± 6.2nm — PASSED
  • Particle Quantity (>10 billion exosomes/mL): PASSED
  • Sterility Test — USP<71> (SCD and FTM): NO GROWTH — PASSED


All donors are pre-COVID and determined to be free from risk factors for, and clinical evidence of, infection due to relevant communicable disease agents. All donors are tested by a CLIA-certified laboratory using approved test methods and deemed eligible according to 21 CFR 1271 Subpart C.


Visual: Particle size distribution graph (FTLA distribution chart from brochure) showing the 70nm peak.

How PBME Topical™ Is Made

Every donor undergoes screening according to FDA standards before manufacturing begins. Each production lot is then tested for purity, sterility, and exosome count using advanced nanoparticle counting technology.


The PBME Topical™ cell line is listed on a Drug Master File with the FDA. To maintain manufacturing consistency, every lot must meet minimum release specifications of:

  • 10 billion exosomes per mL
  • 1,000+ characterized growth factor proteins

Lots that do not meet these requirements are not released for distribution.

Frequently Asked Questions

  • What are bone marrow exosomes?

    Bone marrow exosomes are extracellular vesicles released by mesenchymal stem cells that contain proteins, mRNA, and miRNA involved in cell-to-cell communication.

  • Why are bone marrow-derived exosomes used?

    PBME Topical™ uses bone marrow-derived mesenchymal stem cell exosomes because they originate from one of the most extensively studied cell sources in regenerative medicine.

  • How is PBME Topical™ tested?

    Every manufacturing lot is tested for purity, sterility, and exosome count before release. Products that fail to meet minimum specifications are not distributed.

  • How should PBME Topical™ be stored?

    Refer to the product specifications and storage guidelines provided with the product for handling recommendations.

  • Is PBME Topical™ safety tested?

     Yes. According to the provided information, donors are screened to FDA standards and every production lot undergoes quality testing prior to release.

Experience the Difference of Bone Marrow Exosomes

Learn more about the specifications behind PBME Topical™ or contact our team for pricing and product information.

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