Exosomes

How candidacy for Exosomes is evaluated

• Full medical history, current medications, and prior therapies reviewed at consultation.
• Pregnancy, active cancer, and specific conditions may exclude or modify candidacy.
• Informed consent and physician oversight are required.
• Offered as a physician-supervised regenerative wellness protocol — no FDA-approved exosome products exist and no disease-treatment or cure is claimed.
• Results vary and no specific outcome is promised.

Screening, history, and provider guidance determine whether any protocol is appropriate for a given individual. Results vary.

Where this information comes from

FDA approvals for cellular products are narrow and product-specific: RYONCIL is approved only for pediatric steroid-refractory acute GVHD, and ALLOCORD is approved only for hematopoietic reconstitution in specific disorders. These narrow approvals do NOT validate other MSC, cord-blood, exosome, injection, orthopedic, anti-aging, or wellness uses. There are no FDA-approved exosome products, and published human trials of MSC, exosome, and related regenerative products remain heterogeneous and early-phase.

• RYONCIL (remestemcel-L) — FDA prescribing label

  DailyMed (U.S. National Library of Medicine)

  FDA-approved prescribing information for RYONCIL — the first FDA-approved allogeneic MSC product, limited to pediatric steroid-refractory acute GVHD. Approval does not extend to other MSC uses.

• ALLOCORD (HPC, cord blood) — FDA prescribing label

  DailyMed (U.S. National Library of Medicine)

  FDA-approved prescribing information for ALLOCORD, limited to hematopoietic reconstitution in specific inherited or acquired disorders. Approval does not extend to regenerative, orthopedic, or wellness cord-blood uses.

• FDA consumer alert on regenerative medicine products including stem cells and exosomes

  U.S. Food & Drug Administration

  FDA public alert stating there are no FDA-approved exosome products and describing the limits of FDA-approved regenerative products.

• FDA — Important Patient and Consumer Information About Regenerative Medicine Therapies

  U.S. Food & Drug Administration

  Consumer-facing FDA guidance on how to evaluate marketed regenerative medicine claims and providers.

• Systematic review of mesenchymal stem cell and cell-derived product trials (PMID 38958077)

  Peer-reviewed systematic review (PMID 38958077)

  Systematic review describing heterogeneous, early-phase human trials of MSC and cell-derived regenerative products; overall clinical evidence remains inconclusive.

References describe general evidence, safety, or regulatory context. They do not establish an individual benefit for any specific person, and they do not validate EBO2's proprietary clinic protocols.