Welcome to regenerative medicine.
Cell therapy and tissue engineering are 20 years old!

Antoine Turzi

Antoine Turzi

I/ Welcome to the world of regenerative medicine research 

Some 50 years ago, Prof. Joseph Vacanti (John Homans Professor of Surgery, Massachusetts General Hospital, USA) taught the medical world the concept of tissue engineering in the laboratory, following the proof of concept by Prof. Leonard Hayflich (University of California, San Francisco School of Medicine); the latter demonstrated that by isolating fibroblasts and cultivating them in the laboratory, he obtained 50-60 cell divisions before confluence; then analyzed by INSERM in Paris as the sign of cell apoptosis! https://en.wikipedia.org/wiki/Leonard_Hayflick
Prof. Joseph Vacanti proposed to make a support structure (a "scaffold") of various kinds, either collagenous or synthetic, then seed it with autologous or allogeneic cells, then add growth factors whose function is "biostimulation", to regenerate a new implantable tissue.

Pr Joseph Vacanti and Pr Leonard Hayflick

But the INSERM observation published in "Animal cell cultures "The INSERM study, coordinated by Georgia BARLOVATZ-MEIMON, Monique ADOLPHE, Christiane GUILLOUZO and Xavier RONOT, showed that in vitro and with allogeneic components, apoptosis occurs after a few weeks, as the cells are extracted from their natural environment.
From this point on, we could assume that autologous cells could multiply 500 to 5000 times in their own natural autologous environment. This observation was crucial to the development of Regen Lab's autologous technologies.
Prof. Jean-Hilaire Saurat (Department of Clinical Neurosciences and dermatologyHead of Dermatology, HUG) who invented autohematology therapy over 50 years ago, said to me on retiring: "I'm sorry I didn't meet you sooner, because if I'd understood that effective therapy meant eliminating the red fraction of whole blood, we'd have made a lot of progress".
And it was 20 years ago that the clinical application of PRP (Platelet Rich Plasma) was born.
In 2000, when I became aware of these innovations, I said to myself that if it worked for bone weavers, it could work for so-called "soft" tissues, and I began to investigate the proper use of PRP on chronic wounds and in burn victims.
Then, naturally, the logical step was to use PRP for healthy aging skin and alopecia.
Dr Ghislaine Beilin (a pioneer in aesthetic and anti-aging medicine, and in cutting-edge technologies for medical aesthetics) rightly points out that if there's osteoporosis, there's also dermatoporosis!
The way was paved for the creation of the new dermato-aesthetic medicine, with the aim of reversing the ageing cycle and stimulating healthy tissue in areas depressed by age. We're not talking about regenerating an organ or an entire body, we're talking about topically regenerating tissue damaged by degeneration; in this respect, the term "renenerative medicine" takes on its full meaning.

II/ Standards and regulation in regenerative medicine.

So we're in a serious medical field. Regulators have understood this.
To make a PRP-type cell preparation, you need to use medical devices (MDs) of class IIb or higher, corresponding to the highest hazard class under Directive 93/42.
What does this mean?
  1. The DM manufacturer must have a functional quality system in place, in line with ISO 13 485 and subsequent versions. As the company is certified, it is audited every year.
  2. Each product/accessory must be CE marked; this means that the manufacturing company must build a technical file to support its safety.
  3. In addition, the manufacturing company must provide a Clinical Evaluation Report (CER) to demonstrate clinical efficacy, to justify CE marking and marketing.
But the lives of DM manufacturers were put to the test some time later!
In 2001, the International Conference on Harmonization (CIH) was created. (ICH) grouping all developed countries: the consequence was the creation of the MDSAP (Medical Device Harmonization Program) standard.
Then in 2019, this MDSAP standard came into force and was immediately adopted by Canada and other countries.  
That's why Regen Lab was the only company to exhibit at scientific conferences.
All member countries now pay close attention to compliance with this standard: Canada, USA, Brazil, Australia, Japan.
Then Europe passed the EU-MDR 2017/745 standard. It is now a reference standard! The principle of this standard is to forget the past and evaluate companies for their quality system and then to evaluate each technical file and its clinical evaluation! It's very virtuous, but a nightmare for many companies...
But Regen Lab and our Technical Director Dr Daphné V. Dierman made the right decisions at the right time! Because today, Regen Lab is one of the few companies with EU-MDR quality system certification, and every one of our Medical Devices has been re-assessed for compliance. As a result, Regen Lab is one of the few companies with certificates valid for the next 5 years.

III/ Welcome to Regenerative Medicine under EU-MDR 2017/745
and autologous injectable products for aesthetic medicine.

The August 2019 standard NF EN 16844 A2, "Services in aesthetic medicine - Medical, non-surgical treatments" gives a positive reading on injectables authorized for aesthetic medicine...
In fact, this standard identifies and classifies each product from A to E according to its dangerousness: from A, the least dangerous, to E, the most lethal!
The pleasant surprise is that closed-circuit PRP, like Regen Lab's, is the only one to guarantee a Class A product, whereas open-circuit PRP and HA (hyaluronic acid) and all other products start out as Class B.
So, if clarification is needed, not only is PRP authorized in aesthetic medicine (the French Supreme Court has recognized that aesthetic medicine is real medicine), but PRP (a closed-circuit product, like Regen Lab's) is the least dangerous injectable product in this category, and what's more, it's the most effective.
Welcome to Regenerative Medicine under EU-MDR 2017/7458!