From:  A survey of the composition, safety, efficacy and regulation of non-autologous biologic treatments in human musculoskeletal pathologies

 Homologous use status of NABs, tissues and HCT/Ps with indications for use [1271.10(a)(2)] [4]

Tissue source/TypeDelivery modeIndication or treatment siteRegulatory statusComment
Bone marrow, cord blood, mobilized peripheral bloodInfusionRepair of defective hematopoietic system (acquired, inherited, ablative)361Homologous use
Bone marrow, cord blood, mobilized peripheral bloodInfusionTreat multiple MSK pathologies351Non-homologous use
“Young” plasmaInfusionMultiple pathologies targeted351Plasma isn’t covered by 1271; regulated as a drug under the FD&C Act
Biomolecule secretion from whole tissues (in vitro tissue culture)Implanted; infusionMSK pathologies351Non-homologous use
Cells (in vitro tissue culture)Implanted; infusionMSK pathologies351Non-homologous use
Extracellular vesicles (exosomes) from in vitro tissue cultureImplanted; infusionMSK pathologies351Non-homologous use
Amniotic fluid—no cellsImplantedMSK pathologies351Non-cellular amniotic fluid isn’t an HCT/P; regulated as a drug under the FD&C Act
Amniotic fluid—viable cellsImplantedMSK pathologies351Non-homologous use
Amniotic membraneImplantedBone tissue replacement 351Non-homologous use
Amniotic membraneAppliedWound healing361Homologous use
Amniotic membrane AppliedReduced scarring, mitigating pain351Non-homologous use
Amniotic membraneAppliedSurface of the eye during in-ocular repair361Homologous use
Acellular dermal productAppliedSupport/covering structures like a tendon361Homologous use
Acellular dermal productAppliedTendon repair or replacement351Non-homologous use
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FD&C Act: Food, Drug and Cosmetic Act; HCT/Ps: Human Cells, Tissues and Cellular and Tissued-Based Products; MSK: musculoskeletal; NAB: non-autologous biological