Human Tissue

What is considered Human Tissue under HBRA?

 

Note1: Cell-free samples (e.g. Pure Blood Serum, Pure Blood Plasma and Platelet-rich Plasma(PRP)) are not considered human tissues. 

Note2: HBM which has been substantially-manipulated but is individually-identifiable, is still considered to be "human tissue". 

Note3:  Human blood and blood-derived products that contain human cells (e.g. Peripheral Blood Mononuclear Cells (PBMCs), erythrocytes, leukocytes, buffy coat etc.) which have not been substantially manipulated and anonymised are considered “human tissue”

​Examples considered to be substantial manipulation
​Examples not considered to be substantial manipulation
​Culture expansion of cells* from tissues, cell lines created from tissues, formalinfixed paraffin-embedded tissue, enzymatic treatment to dissociate cell cell contact, breaking open to cells to recover subcellular components. 
*includes creation of induced pluripotent stem cells from primary cells. 
​Cutting, grinding, shaping, centrifugation, sterilization, low-level irradiation, cell separation, concentration/purification, filtering, lyophilisation, freezing, cryopreservation, vitrification.


Click here for more examples of substantial manipulation.  

You may also refer to  MOH's Decision Tool to determine if you fall under HBRA's Human Tissue Framework.