The RegenKit® THT are medical devices intended for the preparation of RegenPRP and are now available in 10 and 20 ml.
They contain RegenTHT® tubes and accessories for blood collection and PRP recovery. RegenTHT® tubes are made of pharmaceutical grade glass with a vacuum for automated blood collection.
They contain a sodium citrate anticoagulant solution and a separating gel to separate plasma and platelets from the blood cells and produce RegenPRP® with a standardized composition.
The performance tests were performed according to the US FDA requirements for platelet rich plasma (PRP) medical devices.
PRP were prepared with the blood from 60 volunteers (30 women and 30 men). Measures were performed at the time of PRP preparation (T=0) and four hours later (T=4H).
The PRP prepared with the RegenTHT device has a very low level of contaminants. Red blood cells are removed at 99.5 %. The white blood cell level is drastically reduced, with a preferential depletion (87 %) of the pro-inflammatory granulocytes (Granulo). The remaining white blood cells are mostly lymphocytes (Lympho) and monocytes (Mono).
The mean PRP volume obtained from 8ml of blood is 4.7 ml. Platelet recovery is around 95 % Platelet concentration factor is 1.7 times over the whole blood value. The flexibility of the system allows to reach a concentration factor up to 5 times (around 1’000’000 platelets/μl) by discarding a part of the plasma poor in platelets (PPP).
Functionality tests were done, according to the US FDA requirements, on PRP from 12 donors.
Platelet in RegenTHT PRP are able to:
– respond to specific ADP activation by an increased expression of P-selectin
– aggregate in presence of collagen
– resist to hypotonic stress
Those biological properties are maintained during the 4 hours of the experiment attesting the integrity and the functionality of the platelets.
Contrary to some competition PRP devices that don’t collect the larger platelets, there is no platelet size selection with RegenTHT tubes.
Mean platelet volume in RegenTHT PRP (7.6 ± 0.7 μm3) is similar to the value obtained in whole blood (7.6 ± 0.6 μm3)
Good quality of the RegenTHT PRP is as well demonstrated by its ability to sustain MNC (mononuclear cell) growth (evaluation made in vitro in RegenTHT PRP kept at room temperature).
Platelets kept in these conditions have similar half life (7 days) as described in whole blood.
The simple, safe and efficient point-of-care preparation of autologous platelet-rich plasma.
Now available in both 10 and 20ml
Regen Lab devices use a separating gel technology that separates the plasma and
platelets from the blood cells to produce RegenPRP with a standardized composition:
1.7 to 5X
Preparation of autologous platelet-rich plasma (A-PRP®) and other plasma-derived products.
Ref: RK-THT-3 Now available in both 10 and 20ml
3 Regen THT tubes
*The BCA-Set 3 Accessory Set is strongly recommended for use with the RegenKit®-THT-3.
Strict aseptic technique must be followed during the whole procedure. Use proper safety precautions to avoid contact with patient blood or cross-contamination. Use proper safety precautions to protect against needles or broken tubes. Do not use sterile component of this kit if it is opened or damaged. Do not use components of this kit if they are broken or present a defect. Do not use the tube if it has lost vacuum. Do not use the sodium citrate solution or other tube components separately. Store between 5 ºC and 30ºC; bring the kit to ambient temperature before using tubes. Do not re-sterilise, do not use after the expiration date. Single use device, do not reuse any part of the kit. Reuse may lead to infection or other illness / injury. Transfer needle must be used to transfer liquids only and should not be used for injection. The preparation of the platelet-rich plasma (PRP) must be performed by a physician trained on the equipment and procedure, or under the supervision of the physician. The treatment with PRP must be performed by a qualified physician. Do not inject PRP intravascularly. The patient must be informed of the general risks associated with the treatment and of the possible adverse effects. The safety and effectiveness of combination of PRP with other therapies should be assessed by the physician. The safety and effectiveness have not been evaluated in children and in pregnant or lactating women. The PRP must be prepared from fresh blood and must be used within four hours (extemporaneous use only).
All tubes and components of the kit are to be entirely discarded by elimination method after each use to avoid potential contamination with blood products. Use a 45° fixed angle rotor centrifuge or a horizontal head swinging bucket centrifuge (ex. RegenPRP Centri provided by Regen Lab). Follow the manufacturer’s instructions when using the centrifuge. Tubes should be centrifuged, as recommended in the instructions for use, at a relative centrifugation force (RCF) of 1500 g. Excessive RCF (over 2200 g) may lead to tube breakage resulting in blood exposure, and possible injury. RCF below 1500 g may lead to incorrect blood separation and red blood cell contamination of PRP. Centrifuge carriers and inserts size should be adapted to the tubes. Use of carriers too large or too small may result in breakage of the tubes. Caution should be taken to ensure that tubes are properly seated in the centrifuge carriers. Tubes must be balanced in the centrifuge.
Blood collection may cause damage of the blood vessels, hematomas, superficial phlebitis, delayed wound healing, early or late infection and/or temporary or permanent nerve damage that may result in pain or numbness.
U.S. patent US8529957
European patent EP2073862B
Swiss patent CH696752
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