What is RegenBCT?
RegenKits BCT are medical devices designed for the production of Regen PRP. They contain RegenBCT tubes and accessories for blood collection and PRP extraction.
The RegenBCT tubes are made of pharmaceutical-grade glass and have a vacuum for automatic blood collection.
They contain a sodium citrate anticoagulant solution and a separation gel to separate plasma and platelets from the blood cells and produce Regen PRP with a standardised composition:
PRP volume per tube
Blood volume per tube
Red blood cell depletion
Platelet concentration factor
5 - 6 ml
> 80 %
> 99.7 %
Summary of new RegenBCT and A-CP tube performance tests-2017, data on file
What is Regen PRP?
Regen PRP: Platelet concentrate prepared with Regen Lab technology provides an autologous reservoir of growth factors.
Platelets are key factors in the mechanisms of tissue repair.2 They provide essential growth factors, such as FGF, PDGF, TGF-β, EGF, VEGF, IGF, which are involved in stem cell migration, differentiation and proliferation. Platelets also stimulate fibroblasts and endothelial cells, inducing the accumulation of new extracellular matrix and neovascularisation. Platelets are concentrated from the patient's own blood.
Blood plasma contains many factors that are important for cell survival, including nutrients such as vitamins, hormones, electrolytes, growth factors (IGF and HGF) and proteins.
Among the plasma proteins are the molecules that are critical to the clotting process and to the formation of the fibrin polymer, which serves as a scaffold for cell migration and new tissue formation.3
Preparation in 3 steps in less than 10 minutes:
Please always read the operating instructions before use:
Intended use of the product:
Preparation of autologous platelet-rich plasma and other plasma-based products.
Class IIb CE certified medical devices
Regen Lab SA is a medical device manufacturer certified to ISO13485 :2016 and MDSAP.
Precautions and warnings:
Sterility must be maintained throughout the phlebotomy procedure. Take adequate precautions to avoid contact with the patient's blood or cross-contamination. Take adequate precautions to protect against needles or broken glass tubes. Do not use any of the sterile components of the kit if the packaging has been opened or damaged. Do not use any component of this kit that is damaged or broken. Do not use the tube if it has lost vacuum. Do not use the sodium citrate or other components of the tube alone. Store between 5ºC and 30ºC; bring the kit to room temperature before use. Do not use after the expiry date.
Disposable; do not reuse any part of the kit. Reuse may cause infection or other illness/injury.
Transfer needles must only be used for fluid transfer or preparation of the injection, but not for the injection itself. Preparation of platelet-rich plasma (PRP) must be performed by or under the supervision of a physician trained in the device and procedures. PRP preparation must only be used by a doctor trained in the procedures. The patient must be informed of general risks and possible adverse effects. The platelet-rich plasma (PRP) must be prepared with fresh blood and used within four hours (product, use as soon as possible and do not store). Dispose of the tubes and other components after use according to the disposal guidelines for potentially contaminated blood products.
Use a centrifuge with swing-out or fixed-angle rotor (e.g. RegenPRP Centri from Regen Lab). Follow the manufacturer's instructions when using the centrifuge. The tubes should be centrifuged at 1500 RZB as described in the instructions for use. High centrifugal forces (greater than 2200 RZB) may cause the tubes to break, come into contact with the blood or possibly cause injury. A lower centrifugal force (less than 1500 RZB) may result in insufficient separation of the blood and contamination of the PRP with red blood cells. The centrifuge inserts should specifically match the size of the tubes. The use of inserts that are too small or too large may cause the tubes to break. Care should be taken to ensure that
the tubes are properly seated in the holder in the centrifuge. The tubes must be balanced in the rotor to avoid possible breakage of the glass.
POSSIBLE SIDE EFFECTS:
Injury to blood vessels, haematoma, delayed wound healing and/or infection. Temporary or permanent damage to nerves which may result in pain or numbness. Early or late surgical infection.