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

 Influence of processing commercial-use HCT/Ps and NABs in meeting the minimal manipulation standard [1271.10(a)(1)] [4]

TissueProperty/FunctionProcessingMinimally manipulated
Placental tissues Physical integrity, tensile strength, elasticity; serves as a barrierSizing as sheets, preservingYes
Grinding (micronizing)-packaged as particlesNo
Removing chorion, preservingYes
Fascia lataStrength, flexibility; cover muscle, aid in movementGrind into particlesNo
Preserved as sheetsYes
SkinFlexible, protective covering; water-resistant epidermis; strong connective tissue of the dermisSheets of skin are meshed and cryopreservedYes
Epidermis is removed, dermis is freeze-driedYes
Epidermis is removed, dermis is ground into particlesNo
Adipose tissueBulky tissue (adipocytes with lipid content); cushioning and supportingDecellularize the tissue, leaving the extracellular matrixNo
Digest the adipose with enzymes, leaving the stromal vascular fraction (SVF)No
Use mechanical means to release and recover the cellsNo
CartilageFirmness, smoothness, resistance to deformation; provides load bearing, reduced friction movementsHomogenize cartilage to yield a slurryNo
LigamentTensile strength; stability and aids in movementDisaggregate the collagen fibersNo
Bone marrowAbility to differentiate into lymphoid and myeloid cells and self-renewCollect, store and distribute donor bone marrow unitsYes
Peripheral blood (mobilization protocol)Ability to differentiate into lymphoid and myeloid cells and self-renewPerform apheresis, concentrate the hematopoietic stem/progenitor cellsYes
Peripheral blood (mobilized), cord blood, bone marrowAbility to differentiate into lymphoid and myeloid cells and self-renewObtain the hematopoietic stem/progenitor cells for culturing and differentiation into terminal (adult) cellsNo
Cord bloodAbility to differentiate into lymphoid and myeloid cells and self-renewCollect, store and distribute cord blood unitsYes
Placental/Umbilical cord tissueStructural tissues with stem/progenitor cellsCulturing of selected cells under conditions that maintain their “stemness”No

HCT/Ps: Human Cells, Tissues and Cellular and Tissued-Based Products; NAB: non-autologous biological