RegenKit® THT® Medical Device Kits are available in 10 mL and 20 mL variations. They contain Regen® THT® tubes for blood collection and PRP recovery. Regen® THT® tubes are composed of pharmaceutical-grade glass with a vacuum for automated blood collection.
They contain a Sodium citrate solution and a thixotropic separating gel, to isolate plasma and platelets from other blood components and produce RegenCell® (Mononuclear-Selective A-PRP®) with a standardized composition.
The Sodium citrate anticoagulant is fully-reversible and pH neutral, lending to a considerably higher patient tolerability and enhanced ease of use.
Intended Use of the Device: All models of RegenKit® THT® are designed to be used for the safe and rapid preparation of autologous platelet-rich plasma (PRP) from a small sample of blood at the patient’s point of care. The PRP is mixed with autograft and/or allograft bone prior to application to an orthopedic surgical site as deemed necessary by the clinical use requirements. RegenKit® THT® models are for single-use only.
The following performance tests were performed according to the US FDA requirements for platelet-rich plasma (PRP) medical devices.
PRP was 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.
Platelets Collected with Regen® THT® are able to:
– respond to specific ADP activation by an increased expression of P-selectin
– aggregate in presence of collagen
– resist 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
Available in both 10 mL and 20 mL Kits.
Regen® Innovative Preparation methods, combined with the “GMP Lab in a Tube” and the Regen® A-PRP® Cellular Selectivity Model, facilitate an efficient and consistent preparation which allows a provider to choose the preparation which best fits their individual patient’s needs.