Understanding regulation of autologous human cell and tissue (HCT) products

Human cell and tissue (HCT) 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 is those commonly referred to as 'stem cell treatments'.

Examples of autologous HCT products

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

• blood and blood components including red cells, plasma, serum, platelets, platelet-rich plasma (PrP), platelet-rich fibrin (PRF) and conditioned serum
• skin grafts for treatment of burns
• bone grafts
• genetically-altered lymphocytes to target cancers
• adipose-derived cell extracts including stromal vascular fraction (SVF).

This document specifies only TGA regulatory requirements. Other regulatory requirements that 
may apply to these products include:

• Australian Health Practitioner Regulation Agency (AHPRA)
• state, territory and national medical and dental boards or councils
• the Australian Competition and Consumer Commission (ACCC)
• state and territory management and administration of public hospitals
• state and territory licensing of private hospitals.

The level of regulation for autologous HCT products is based on the level of risk to the public.

The level may vary due to the level of external governance and clinical oversight, or depending on the manufacturing processes or intended use of the autologous HCT product. 

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

1. excluded from TGA regulation
2. regulated by TGA with exemptions from some requirements
3. fully regulated by TGA (as a medicine or biological).

For autologous HCT products that are not excluded from TGA regulation, the product will be 
one of the following:

• a medicine, if it fits the definition of blood, blood component or haematopoietic progenitor 
  cells (HPCs)
• a biological.

Biologicals and excluded autologous HCTs must not be advertised to consumers.

*Medicine: if meets the definition of blood, blood component or haematopoietic progenitor cells (HPC).

If an autologous HCT product is not excluded or not exempt, then it is fully regulated as either a biological or blood component.

If your autologous HCT product is not a blood component, then it will be regulated as a 
biological. Please refer to the Australian Regulatory Guidelines for Biologicals (ARGB).

‘Blood’ and ‘blood components’ and haematopoietic 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, including red cells, white cells, platelets, plasma, serum, platelet-rich plasma (PRP), platelet-rich fibrin (PRF), conditioned 
  serum, that can be prepared by centrifugation, filtration and freezing, but not including 
  haematopoietic progenitor cells
• haematopoietic progenitor cells means self-renewing or multi-potent stem cells, or both, 
  capable of maturation into haematopoietic lineages, lineage-restricted pluripotent 
  progenitor cells, or committed progenitor cells.

If not excluded or exempt, autologous blood, blood components and haematopoietic progenitor cells (HPC) are regulated as a medicine in the same way as non-autologous blood, blood components and HPCs.

If your product does not fit the appropriate definition, then it will be regulated as a biological.