Regulatory Guidelines for Autologous Biological Products

What are autologous products?

Human cell and tissue products are those that comprise, contain, or are derived from human cells and tissues. Autologous human cell and tissue (HCT) products are those that are removed from and applied to the same person, i.e. the donor and the recipient are the same. 

One group of autologous HCT products are commonly referred to as ‘stem cell treatments.

Examples of autologous HCT products

Some examples of human cell and tissue products that can be autologous are:

  • Blood and blood components (red cells, plasma, serum, platelets, platelet-rich plasma [PRP], platelet-rich fibrin [PRF], and conditioned serum)
  • Skin grafts for the treatment of burns
  • Bone grafts
  • Genetically-altered lymphocytes to target cancers
  • Adipose-derived cell extracts (including stromal vascular fraction (SVF))
  • External regulatory oversight of autologous HCTs

You can buy these high-quality autologous biologics products from 5 Line Biologics.

To determine how your autologous product will be regulated check if it is:

  • Excluded from TGA regulation
  • Regulated by TGA with exemptions from some requirements
  • Fully regulated by TGA (as medicine or biological)

Checking if it is blood, blood component, or HPC

‘Blood’ and ‘blood components’ and hematopoietic progenitor cells (HPC) are defined in the latest Therapeutic Goods (Manufacturing Principles) determination:

Blood means whole blood collected from a single human donor and processed either for transfusion or further manufacturing.

Blood components means the therapeutic components of blood (red cells, white cells, platelets, plasma, serum, platelet-rich plasma, platelet-rich fibrin, conditioned serum) that can be prepared by centrifugation, filtration, and freezing, but not including hematopoietic progenitor cells.