Standardized Platelet-Rich Plasma for Musculoskeletal Disorders

REGENPRP & THE CELLULAR MATRIX PLATFORM FOR THE COMBINATION OF REGENPRP WITH HYALURONIC ACID

Third Edition revised and updated

Authors: Antoine Turzi, REGEN LAB Team

Hardcover
176 pages full color
Size: 21×29,7cm
Published: 2024

This book is a result of 20 years’ experience of R&D developing and promoting platelet rich plasma (PRP), and more recently PRP combined with hyaluronic acid, which are among the new cell therapies for musculoskeletal indications, what we call today “orthobiologics”.
Since 2003, Regen Lab has developed certified medical devices allowing the preparation of standardized PRP from the patient’s blood in an automated and efficient manner. The resulting RegenPRP has a constant, operator independent composition, with more than 80% of the platelets recovered in the full volume of plasma. It also has a low level of blood cell contaminants. The recovered platelets are fully functional and the platelet to plasma ratio is physiological, with a platelet concentration factor between 1.5 and 3 times the baseline value in blood. Such PRP is relevant for therapeutic use, since at this physiological concentration it does not affect tissue homeostasis, and the low level of cellular contamination reduces the risk of undesired inflammatory reactions. With high quality RegenPRP there is no need to further concentrate the platelets.
There is a wrong belief that PRP should always have a platelet concentration of 1 million platelets per microliter, which corresponds to a 4- to 5-fold increase over baseline, to be therapeutic. This concentration was first mentioned in the landmark publications on PRP by Prof. Robert Marx (Marx, 2004; Marx et al., 1998). This empirical value has never been scientifically validated nor has its superiority to lower concentrated PRPs, prepared with effective technologies, ever been demonstrated in comparative clinical studies. This level of platelet concentration usually applies to PRPs highly contaminated with red and white blood cells. As these cellular contaminants delay the healing process, a higher concentration of platelets is probably needed in these types of PRPs to compensate for the negative effect of red and white blood cells on the healing process.
Going forward, standardized physiological PRP should supersede more concentrated PRPs prepared with archaic technologies, as high concentrations of platelets in PRP no longer seem to be relevant for successful clinical outcomes in 2020.
Numbers speak for themselves – by 2019, two million patients had been treated successfully with RegenPRP in various therapeutic areas. Thus, there is no doubt that we are in the presence of an effective therapy.
The clinical results presented in this book are based on the results of the Clinical Evaluation Report for RegenKits, performed in accordance with the requirements of the European Commission Guideline MEDDEV 2.7/1 revision 4. These results show that leukocyte-poor physiological RegenPRP is effective not only for the treatment of osteoarthritis but also for tendinopathies and other musculoskeletal disorders.
However clinical efficacy is not enough. The technology should also be safe for the patient and the operator. PRP prepared with closed circuit devices has been certified as the safest injectable technique in the European Norm EN 16844:2017+A2:2019 recently updated. The processing of blood in fully closed-circuit systems, like in Regen Lab devices, allows the risks of microbial contamination of the sample and operator exposure to the patient’s blood to be minimized.
What we were looking for in this book is the scientific demonstration of the safety and clinical efficacy of RegenPRP and its combination with hyaluronic acid, and the great value of an incontestable new medicine for physicians and patients!

Antoine Turzi