Welcome to regenerative medicine.
Cell therapy and tissue engineering are 20 years old!
CEO of REGENLAB
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.
First in dental implantology with the Prof. Robert Marx https://www.sciencedirect.com/science/article/pii/S1079210498900294 https://www.pikossymposium.com/dr-robert-marx-2/
And then in many other applications: Dr. R. Knighton was the 1er inventor of the use of PRP for the regeneration of chronic wounds. https://pubmed.ncbi.nlm.nih.gov/7584002/
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?
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.
Each product/accessory must be CE marked; this means that the manufacturing company must build a technical file to support its safety.
In addition, the manufacturing company must provide a Clinical Evaluation Report (CER) to demonstrate clinical efficacy, to justify CE marking and marketing.