Autologous platelet-rich plasma and conditioned serum regulation
This guidance is for sponsors of platelet-rich plasma and conditioned serum. It will help you work out if your product is excluded, regulated as a blood component (medicine) or as a biological.
Autologous platelet-rich plasma (PrP) and conditioned serum are products made from blood collected from a patient which is subsequently processed and returned to the same patient. Commercially supplied kits and equipment are available for the processing of the collected blood.
Where the products are used for a therapeutic purpose, they would be regulated under the Therapeutic Goods Act 1989 by the TGA, subject to any applicable exclusion.
It should be noted that the introduction of the Biologicals framework in 2011 and the amendments to the regulation of certain autologous HCT products in July 2018 have not had a significant impact on the regulation of blood components, which includes most autologous PrP products.
Medical devices or equipment used for manufacture of PrP and conditioned serum may be regulated under the medical devices framework, where it is to be used for treatment, diagnosis or modification of a patient's anatomy or physiological process. In such cases, manufacturers of the equipment must have sufficient evidence, including clinical evidence, to substantiate their claims about safety and performance of the products. This information would need to be provided to the TGA if requested.
Autologous platelet-rich plasma (PrP)
Platelet-rich plasma (PrP) is prepared from blood collected by a single uninterrupted venepuncture. The plasma is generally separated from the red blood cells by centrifugation, with the platelets present in the plasma. The next steps vary between protocols but are intended to discard both the red blood cells and the acellular plasma layers and to collect only the platelet rich plasma layer. Commercial kits are now available to assist in the preparation of PrP. Importantly, the preparation of PrP only separates and concentrates the cells without manipulating them.
Most autologous PrP would be regulated as a blood component (medicine)
Platelet-rich plasma (PrP) is likely to be considered a blood component, being prepared only by centrifugation, filtration and freezing.
Advertising for blood components (medicines) to the public is not prohibited, but advertising must comply with the requirements of the Act and the Therapeutic Goods Advertising Code (the Code).
Where PrP is mixed with other cells, tissues or other ingredients prior to use, the product is unlikely to meet the definition of PrP and could be subjected to regulation as a biological.
'Cosmetic use' of injected PrP or conditioned serum is likely to be regulated by TGA where therapeutic claims are made or inferred. Generally, injectable products are not cosmetics and fall under the Australian legal definition of therapeutic use.
When the blood collected from a patient who is under the clinical care of a medical or dental practitioner and PrP manufactured and used within a hospital, it is likely to be excluded from TGA regulation.
The use of PrP may be exempt from certain TGA regulatory requirements when all of the following criteria are met:
- collected from a patient who is under the clinical care of a medical or dental practitioner registered under a law of a State or an internal Territory
- manufactured and used by the practitioner with primary responsibility for clinical care OR by a person or persons under the professional supervision of that practitioner
- for a single indication in a single clinical procedure
- are minimally manipulated and for homologous use.
It should be noted:
- These exemptions only apply when the PrP is manufactured and administered by or under the supervision of a registered medical or dental practitioner for a patient under their care. This exemption does not apply to other health practitioners.
- The intended clinical use of PrP under these exemptions should still be justified based on proven evidence of safety and efficacy.
- Where one or more criteria are not met, the exemptions from certain regulatory requirements do not apply.
- Where equipment (such as a commercial kit) is used in the manufacture of PrP or conditioned serum it may also be subject to regulation as a medical device.
For information on the exemption and the regulatory requirements that apply to these products refer to exempt autologous HCT products.
If the exclusions or exemptions do not apply, the PrP may be regulated as a blood component or a biological.
Autologous conditioned serum
Conditioned serum is made from a blood collection, but involves use of the serum fraction which does not contain platelets. In contrast to PrP, the serum is cultured to induce the white blood cells to produce anti-inflammatory compounds in to the serum, so this product is considered manipulated (see definition of minimal manipulation).
Autologous conditioned serum is regulated as a biological
A conditioned serum product is unlikely to meet the definition of a blood component due to the culturing of the blood to induce the white cells to release factors, and would be regulated as a biological.
As it is regulated as a biological, advertising to the public is prohibitedfor conditioned serum.