PRPGENEA™

Autologous platelet enriched plasma (PRP) in plastic surgery and cosmetics.

The procedure consists of the followings Standard Operating Procedures:

Collection:

The (PRP) is collected by phlevotomist in sterile environment according to a standarized peripheral blood venupuncture procedure. (100 c.c peripheral blood). Platelets, an important reservoir of growth factors in the body, play an important role in ...

The (PRP) is collected by phlevotomist in sterile environment according to a standarized peripheral blood venupuncture procedure. (100 c.c peripheral blood). Platelets, an important reservoir of growth factors in the body, play an important role in many processes such as coagulation, immune response, angiogenesis and the healing of damaged tissues. Numerous proteins are contained in the alpha-granules of platelets: platelet-derived growth factor (PDGF), transforming growth factor (TGF), platelet factor interleukin (IL), platelet-derived angiogenesis factor (PDAF), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), insulin-like growth factor IGF and fibronectin. The development of methods and systems for blood and cell sorting (e.g. CAPSS - compact advanced platelet sequestration system Elektromedics 500, PCCS - platelet concentrate collection system Curasan) have made it possible to obtain significant concentrations of platelets (even by 338 percent) and high concentrations of growth factors, in a form of sterile mass that can be used immediately for clinical purposes. Platelet-rich plasma (PRP; autologous platelet-rich plasma - APRP) are platelet concentrates made of autogenous blood with a high number of platelets in a small volume of plasma. The clinical efficacy of platelet concentrates depends mainly on the number of platelets and the concentration of their growth factors, which act as transmitters in most processes in tissues, particularly in healing where they are responsible for proliferation, differentiation, chemotaxis and tissue morphogenesis. They operate as part of autocrine, paracrine and endocrine mechanisms. Growth factors derived from centrifuged blood were first used in patients with chronic skin ulcers. The clinical use of PRP for a wide variety of applications has been reported mostly in oral and maxillo-facial surgery, orthopedic surgery, treatment of soft tissue diseases and injuries, treatment of burns, hard-to-heal wounds, tissue engineering and implantology.

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Processing:

The PRP sample is being coded with a unique barcode for its traceability both during the processing and after the release. Sample processing is being carried out immediately upon receive with validated procedures in a completely closed system (biogenea® set). In particular, the PRP are being ...

The PRP sample is being coded with a unique barcode for its traceability both during the processing and after the release. Sample processing is being carried out immediately upon receive with validated procedures in a completely closed system (biogenea® set). In particular, the PRP are being isolated from peripheral blood according to a centrifugation procedure. The whole procedure is being carried out in a laminar flow class A/B (Annex I - February 2008 EU guideline for the cGMP standards).

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Quality Control:

A small amount of the stem cell culture is controlled for the presence of aerobic and anaerobic germs using the automated blood culture system, while in parallel automated genetic analyzer is used for the detections of HBsAg, as well as for Hepatitis C, HIV Ι/ΙΙ , Toxoplasma , Syphilis and CMV.
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Long term Cryopreservation & Product Release:

Only after the completion of all the quality tests isolated PRP are stored in temperatures reaching the -196C ( in these conditions all the metabolic procedures are stopped ) and document/certificate of cryopreservation is issued. Product Release contains a quality certification:
Mean of standarized PDGF, IL, TGF, VEGF, PDAF, IGF, EGF, units / 5 ml PRP for s.c or i.m or i.d injection
Injections: 1 dose/ 21 days in total 3 doses

Clinical Indications:

PRPGENEA™ is released only according to hospital exception procedure (1394/2007 E.C) to specific oral and maxillo-facial surgery, orthopedic surgery, treatment of soft tissue diseases and injuries, treatment of burns, hard-to-heal wounds, tissue engineering and implantology.