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What is A-PRP®?

  • A-PRP® stands for Autologous - Platelet Rich Plasma.

  • The physician draws a small amount of venous blood and isolates the red cells from a platelet concentrate, embedded in its own plasma. The entire process takes less then 10 minutes.
  • As the Autologous - Platelet Rich Plasma (A-PRP®) is processed from the patients own blood, there is no risk of allergy or rejection with this treatment.

A-PRP® Components

Platelets are key factors in hard and soft tissue repair mechanisms. They provide the essential growth factors FGF, PDGF, TGF-ß, EGF, VEGF, IGF that are involved in stem cell migration, differentiation and proliferation. The stimulation of fibroblasts and endothelial cells induces new extracellular matrix deposition and neo-vascularization.

Plasma is essential for cell survival as it contains nutrients, vitamins, hormones, electrolytes and proteins. Proteins are key molecules for the coagulation process and the formation of the fibrin polymer that will serve as a scaffold for cell migration, differentiation and proliferation.

Optimal Platelet Concentration

The Regen BCT (Blood Cell Therapy) tube prepares 4 to 5ml of autologous platelet rich plasma with a platelet recovery superior to 80% and a concentration factor of 1.6-fold. Although the system is technically capable of producing significantly higher platelet concentrations, it is not what research shows to be beneficial for clinical use. More and more studies demonstrate that concentrations of platelets 1 to 3 times over the baseline show more robust healing rates than those with concentrations of 3 to 8 times the baseline1.

Some studies even showed that too high platelet concentrations may actually have negative effects. In a in vivo study2 it was shown that highly concentrated platelet preparations had an inhibitory influence on osteoblast activity, probably due to unwanted inhibitory and cytotoxic effects of growth factors at such high concentrations. Similarly an in vitro study3, demonstrated that platelet concentration over 2.5-fold, resulted in a reduction in proliferation and a suboptimal effect on osteoblast function.

White Blood Cells in Tissue Regeneration

White blood cells are strongly reduced (> 85% depletion) in Regen BCT A-PRP®.

The role of white blood cells (WBC) in healing is controversially discussed among physicians. To address this concern scientifically, WBC subsets, granulocytes and mononuclear cells, need to be looked at individually. Granulocytes, and more specifically neutrophils, are the front-line defenders against invading pathogens and are associated with the inflammatory response. They release a large variety of highly active antimicrobial substances and proteases. Uncontrolled release of these factors can cause severe damage to the tissue, delay healing rates and increase the risk of scarring4. Thanks to the RegenKit BCT technology more than 96% of the granulocytes are removed from A-PRP®.

The few white blood cells still present in A-PRP® are mostly mononuclear cells (lymphocytes and monocytes). These two cell types are also involved in the immune response but have been shown to support the healing process5,6.

1- Rappl LM et al. Effect of platelet-rich plasma gel in a physiologically relevant platelet concentration on wounds in persons with spinal cord injury. Int Wound J 2011; 8:18.7–195. 2- Weibrich G. et al., Effect of platelet concentration in platelet-rich plasma on peri-implant bone regeneration. Bone 2004; 34:665-671. 3- Graziani F. et al.,The in vitro effect of different PRP concentrations on osteoblasts and fibroblasts. Clin. Oral. Impl. Res. 17, 2006; 212–219. 4- Brubaker A.L. et al. Neutrophils and natural killer T cells as negative regulators of wound healing. Expert Rev. Dermatol. 2011; 6(1), 5- Barbul, A.et al. Wound healing in nude mice: a study on the regulatory role of lymphocytes in fibroplasia. Surgery 1989;105(6): 764-769. 6- Brancato S.K. and Albina J. E. Wound Macrophages as Key Regulators of Repair. Am J Pathol 2011, Vol. 178, No. 1, 19-25

Information for Patients

Products Our assortiment of RegenLab Kits.


RegenKit BCT - Product Highlights

Simplicity:
Only a few steps are required toprepare 4 to 5 ml of Autologous Platelet-Rich Plasma (A-PRP®).

Low Blood Volume Required:
RegenKit® BCT is designed to prepare Autologous - Platelet Rich Plasma from only 8 ml of blood.

Optimum Platelet Recovery:
RegenKit® BCT you recover around 80% of the platelets from the whole blood. Platelets are concentrated in Autologous Plasma.

Consistent Isolation of PRP:
RegenKit® BCT uses a physical barrier (thixotropic gel) to separate the red blood cells from the plasma and the cellular sediment. The preparation is safe and consistent.

Red Blood Cell Depletion:
The level of Red Blood Cells is drastically reduced, with more than 99,7% of complete Red Blood Cell removal.

The RegenLab BCT family kits are designed to prepare Autologous - Platelet Rich Plasma from a small sample oft he patients own blood. Each BCT tube draws 8cc of venous blood and yields 4-5cc of Autologous - Platelet Rich Plasma. RegenLab USA offers procedure kits consiting 1, 2 or 4 BCT processing tubes. Which kit to use ist to be determined by the physicians required volume of PRP. The RegenKit BCT 1, 2 and 4 consist of all blood draw and transfer accessories. The RegenKit BCT 3 contains 3 processing tubes only, individually sterile packed. Please refer to the videos below for instructions of use.

WARNINGS AND PRECAUTIONS 1. Use proper safety precautions to guard against needles. 2. Use a horizontal head (swinging bucket) centrifuge or a fixed angle head centrifuge. Follow manufacturer instructions when using centrifuge. 3. Excessive centrifugation force (over 2200 RCF) may cause tube breakage, exposure to blood, and possible injury. RegenBCT tubes should be centrifuged, as recommended in the instructions for use, at 1500 RCF. 4. Centrifuge carriers and inserts should be of the size specific for the RegenBCT tubes. Use of carriers too large or too small for the tube may result in breakage. Care should be taken to ensure that RegenBCT tubes are properly seated in the centrifuge cup. Tubes must be balanced in the centrifuge head to minimize the possibility of glass breakage. 5. Do not use sterile component of this kit if package is opened or damaged. 6. Single use device, do not reuse any part of the kit. 7. The practitioner is to be thoroughly familiar with the equipment and the procedure prior to using the kit8. The patient is to be made aware of general risks associated with treatment and possible adverse effects. 9. PRP concentrate is to be prepared from fresh blood and used extemporaneously. 10. The platelet rich plasma must be used within four (4) hours of blood collection. 11. Store between 5 oC - 30oC – Bring kit at ambient temperature before using RegenBCT tubes. 12. Do not use components of this kit if they are broken or present a defect.
POSSIBLE ADVERSE EFFECTS 1. Damage to blood vessels, hematoma, delayed wound healing and/or infection. 2. Temporary or permanent nerve damage that may result in pain or numbness. 3. Early or late operative infection.

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Application

The RegenKit BCT product family is indicated by the US FDA for the safe and rapid preparation of autologous platelet-rich-plasma (A-PRP®) from a small sample of blood at the patients point of care. The PRP is mixed with autograft and / or allograft bone prior to application to a bony defect for improving handling characteristics. The RegenKit BCT family kits are for single use only.

Video

Instructional Video using the RegenKit BCT 1

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RegenLab USA offers physicians based in the United States PRP preparation kits at the most competitive prices in the industry along with scientific support and great service.

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Tel / Fax: 1-800-220-9082
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