Influence of processing commercial-use HCT/Ps and NABs in meeting the minimal manipulation standard [1271.10(a)(1)] [4]
| Tissue | Property/Function | Processing | Minimally manipulated |
|---|---|---|---|
| Placental tissues | Physical integrity, tensile strength, elasticity; serves as a barrier | Sizing as sheets, preserving | Yes |
| Grinding (micronizing)-packaged as particles | No | ||
| Removing chorion, preserving | Yes | ||
| Fascia lata | Strength, flexibility; cover muscle, aid in movement | Grind into particles | No |
| Preserved as sheets | Yes | ||
| Skin | Flexible, protective covering; water-resistant epidermis; strong connective tissue of the dermis | Sheets of skin are meshed and cryopreserved | Yes |
| Epidermis is removed, dermis is freeze-dried | Yes | ||
| Epidermis is removed, dermis is ground into particles | No | ||
| Adipose tissue | Bulky tissue (adipocytes with lipid content); cushioning and supporting | Decellularize the tissue, leaving the extracellular matrix | No |
| Digest the adipose with enzymes, leaving the stromal vascular fraction (SVF) | No | ||
| Use mechanical means to release and recover the cells | No | ||
| Cartilage | Firmness, smoothness, resistance to deformation; provides load bearing, reduced friction movements | Homogenize cartilage to yield a slurry | No |
| Ligament | Tensile strength; stability and aids in movement | Disaggregate the collagen fibers | No |
| Bone marrow | Ability to differentiate into lymphoid and myeloid cells and self-renew | Collect, store and distribute donor bone marrow units | Yes |
| Peripheral blood (mobilization protocol) | Ability to differentiate into lymphoid and myeloid cells and self-renew | Perform apheresis, concentrate the hematopoietic stem/progenitor cells | Yes |
| Peripheral blood (mobilized), cord blood, bone marrow | Ability to differentiate into lymphoid and myeloid cells and self-renew | Obtain the hematopoietic stem/progenitor cells for culturing and differentiation into terminal (adult) cells | No |
| Cord blood | Ability to differentiate into lymphoid and myeloid cells and self-renew | Collect, store and distribute cord blood units | Yes |
| Placental/Umbilical cord tissue | Structural tissues with stem/progenitor cells | Culturing 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