Question: Hi I really appreciate your blog – it has some very reliable advice on various hairloss treatments and related research. I am curious about a hairloss treatment called Regenera Activa – it claims to be FDA and EU certified and seems to be very popular in terms of facilities offering it but I cannot find any research or press on the subject and it is not mentioned on your blog. Unless I have missed it somewhere. What is the Belgravia in-house view on this treatment (presumably you have chosen not to offer it?)
Answer: Hi, Mark. Many thanks for your kind words about the Belgravia blog, we’re glad you find it useful.
I have looked into Regenera Activa for you and this is an overview of my thoughts on the matter…
Although it may initially look like a type of harvesting tool used in hair transplant surgeries, the Regenera Activa system – called Rigenera (pictured) – though it does also collect hair follicles – breaks these donor follicles down to cells.
I believe the theory behind this micrografting method, which comes from Barcelona, is for these cells to act as stem cells and regenerate hair follicles when injected into the scalp. According to hair loss research information on the company website:
‘In this preliminary study, the authors have developed a new method to isolate human adult stem cells by mechanical centrifugation of punch biopsy from human hair follicles without culture condition, and they reported for the first time, up to our knowledge, the counting of these cells and the preliminary results obtained by the human follicle stem cells injections in the scalp of patients affected by AGA [androgenetic alopecia aka genetic hair loss], improving hair density.’
Regarding the FDA and European authorisations you mention this device having, the FDA clearance from the USA and CE kitemark it has been awarded for Europe relate to the marketing of the product.
CE kitemark certification is awarded to show that devices meet the relevant necessary EU directive criteria. Usually for medical devices this relates to their safety and, essentially, acknowledging they have been shown to do what they claim to. When they have been awarded CE certification – or FDA clearance – the devices can then be marketed for this specific purpose.
What these marks and clearances do not necessarily indicate is how effective a device is at doing what it claims to.
Regenera Activa literature claims the technique produces new hair growth. Although it does show convincing photos, in my opinion I am still quite sceptical that the technique can create new hair growth, until actual hair follicles can be regenerated.
One of the good things about this novel procedure – as with existing FUE and FUT hair transplantation methods – is that they all use the patients’ own blood or tissues for the treatment. This helps to eliminate allergic reactions or rejection.
The idea appears to be sound and it is likely there is future in the concept. However, at the moment that’s all it is – a concept – as despite on-going research into this, no-one has yet been able to regenerate hair follicles in vitro.
Should it become possible to regenerate follicles in this way, assuming it was shown to be both safe and effective, how hair loss – including both Male Pattern Baldness and Female Pattern Hair Loss – is treated will change quite significantly. This would be a great breakthrough.
With regard to using Regenera Activa’s system, assuming that it works, as a means for preventing baldness from Male Pattern Hair Loss, patients would face the same issues that those who undergo hair transplants do in relation to long-term preservation of their results.
Namely, they would still need to use on-going aftercare which, at present, takes the form of either or both of the only MHRA-licensed and FDA-approved hair loss treatments. These are topical applications of high strength minoxidil to encourage hair growth, and one-a-day tablets of finasteride 1mg which inhibits the hormone which causes genetic hair thinning – dihydrotestosterone, better known as DHT.
DHT binds to susceptible hair follicles – those located from crown to hairline and temples – in men (and women) with pattern hair loss as they have an inherited sensitivity to the testosterone byproduct. This is a process known as follicular miniaturisation.
Even after any form of surgical hair restoration, DHT will continue to attack these hair follicles in genetically prone individuals, however, it will only result in further hair loss in the original follicles – not those replaced during surgery.
As these grafting procedures are rarely carried out on the entire area that is susceptible to Male Pattern Baldness, failing to deter further hairloss in this type of way may result in hair thinning and shedding around the restored areas. This can lead to extremely unnatural looking hair growth patterns, such as developing ‘islands’ of transplanted hairs surrounded by thinning areas or a receding hairline.
This may no longer be a concern should follicle regeneration become possible in humans as over-harvesting and having sufficient donor hair to carry out hair restoration involving the entire area affected by genetic hair loss would be less of an issue, if at all. The price may still provide a barrier though, at least while the procedure was new and limited in its availability – not to mention being in high demand should it be the first, or among the first, to offer hair replication techniques.
We will follow the development of Regenera Activa and publish updates on our blog as more information becomes available. Belgravia will not, however, be offering this type of invasive procedure as we specialise in non-surgical hair loss solutions and hair growth supporting products.
The Belgravia Centre is an organisation specialising in hair growth and hair loss prevention with two clinics and in-house pharmacies in Central London, UK. If you are worried about hair loss you can arrange a free consultation with a hair loss expert or complete our Online Consultation Form from anywhere in the world. View our Hair Loss Success Stories, which includes the world’s largest gallery of hair growth comparison photos and demonstrates the levels of success that so many of Belgravia’s patients achieve. You can also phone 020 7730 6666 any time to arrange a free consultation.