Safety in Regenerative Medicine & PRP

Safety in PRP & Regenerative Medicine Treatments

Hawksley wants to be leading the way in improving the safety of regenerative medicine treatments. Lots of factors impact how safe a treatment is, which start at sourcing materials and finish with the clinician delivering the treatment. This page will cover some of the key aspects of safety in regenerative medicine and advice for practitioners.

Our skin is the major barrier that stops cytotoxic and allergenic material causing real damage. The challenge for regenerative medicine treatments is that they are mostly injected below the skin (derma) or on damaged skin that isn’t functioning properly. It means that clinicians delivering these sorts of treatments should be very careful that they aren’t risking their patients health.

If you don’t ensure you are working safely, you could harm your patient, which is no good ethically, for your reputation, or for your finances.

 

Biocompatibility of Materials

Our biology is delicately balanced to keep us alive and healthy – it needs to be balanced because people are simply complex systems of cell functions coordinated by our nervous system, cardiovascular system, and reflexive cellular functions. This means that the human body responds aggressively if it believes that something is compromising those functions. It responds this way for good reason; as many substances and things are toxic to us and the cells that make up the human body.

Some parts of our body are more robust at fighting against cytotoxicity (like the top layer of skin or our digestion system). However, because regenerative medicine treatments are being into areas of the body without in-built protection, the risk of adverse effects is amplified.

Therefore, manufacturers need to test all the materials they plan on using:

• Plastics: some plastics can lead to allergic reactions or worse. This is because plastics slowly break down into microplastics that are often toxic to our cells (cytotoxicity). A lot of research has been done on how the microplastics in takeaway containers or food wrapping can have profound negative effects on our health. As mentioned before, because regenerative medicine treatments treat areas much more sensitive than digesting microplastics, it is absolutely vital that suppliers are using plastics that are certified as completely safe for the human body.
• Metal: Metals are another material that the body can have severe adverse reactions to. An extreme and famous example of this being that many people used to die from drinking water stored in lead tanks. Manufacturers have to be very careful that the metals used in medical devices are not initially harmful and are of a sufficient quality that they won’t break down and cause other damages.
• Anticoagulants: PRP requires an anti-coagulant to stop the collected blood from forming a solid or clot. The most common way of achieving this goal is to use a naturally occurring salt, called Sodium Citrate. It is a substance regularly used in medicine, as it can be combined with donated blood to keep it viable and we have been doing this for decades. However, there are two important things to remember; not all anticoagulants are Sodium Citrate, and not all Sodium Citrate is made in the same way.

 

Tubes may contain other types of reagent; Serum Gel, Thrombin, Lithium, K2 EDTA, K3 EDTA, Acid Citrate Dextrose. Most of which are not suitable to inject into a human body, some substances like K2 EDTA are synthetic and cannot be broken down by our bodies (meaning it stays in our system permanently).

 

But also, sodium citrate is a salt of citric acid and is a generic term. It is used for lots of different things in chemistry and biology labs. It can be made to different qualities depending on its purpose. If needed for simple diagnostics, the purity of it is not so important and it could well be manufactured using harsh chemicals or chemical processes. The end result would be a sodium citrate harmful to the human body.

CE Marks & IVD vs MDR regulations

Everything mentioned above may seem like a minefield! But once you know what certifications to look for, you can always find safe and legal regenerative medical products. You will know that your products are safe for use if they are a class IIb medical device. You can find this out be requesting for a certificate from the place you order your supplies from. It should state that the product is class IIb or class IIa and look a bit like this:

You can also look at the product box to help. If the product has a CE stamp with a tail number (e.g. 0123 or 0394) it will usually be fine for your use. This CE mark with numbers after it means that they are a medical device that conform to a specific set of regulations for safety.

The biggest thing to be aware of, is that some sellers will pretend that their tubes are safe, by showing a Declaration of Conformity or CE certificate for an IVD product. IVD stands for the In-Vitro Device Regulations that applies to all medical equipment made for laboratory use only – all IVD equipment has never been tested that it is safe for humans. Instead, look for products that are part of the MDR (Medical Device Regulations). This Is the other set of medical device regulations that include all products used on humans. In order to achieve this standard, manufacturers need to provide evidence of safety (for materials, sterility, treatment protocols) and demonstrated through tests and scientific publications.

So, when shopping, be sure to look for Class IIb MDR products that can have a suitable CE certificate and the product has a tail number, with a physical address for the product manufacturer, so it can be traced properly.

 

Case Study

In 2018, 1 young person went blind after a PRP procedure supposed to treat wrinkles under the eyes. The possibility of practitioner error was ruled out because the PRP was injected superficially and the sample only had the patients blood, which would not cause harm. The 3 possible explanations were all down to toxicity in the tubes; all of which came from the fact that the tubes were not tested for use in the human body. These explanations were:

1. Microplastics in the plastic broke down and caused cell necrosis that carried all the way into the optic nerve
2. Optic cell necrosis was caused by the petro-jelly that was harvested, causing a release of endotoxins
3. The sodium citrate was processed with harmful chemicals and led to an adverse reaction that led to blindness

Because the clinic was not doing their due diligence in purchasing safe and suitable consumables, they were sued – losing their legal battle. They lost their business and had to declare bankruptcy, and their patient has irreversible loss of vision.