BMAC preparation and administration is a clinical procedure performed by the treating physician, outside PB's scope. Literature describing marrow aspirate often references the ISCT minimal criteria used to define mesenchymal stromal cell populations when characterizing cellular content.
Regulatory status should not be inferred from autologous or same-day language alone. BMAC and donor-derived allografts such as umbilical cord or placental products are sourced differently, and clinics should refer product-specific classification questions to their own counsel rather than assuming equivalence under a shared 'biologics' label.
Clinics offering BMAC alongside donor-derived allografts should maintain separate documentation trails: device or kit records and procedure notes for BMAC, and lot-level donor eligibility, sterility testing and certificate-of-analysis records for allograft products, since the two rely on different sourcing and testing chains.
BMAC and donor-derived allografts are sourced differently. Clinics should keep separate documentation and refer classification questions to counsel rather than assuming equivalence.