Double Syringe System Autologous Conditioned Plasma

Transcription

1 TM Double Syringe System Autologous Conditioned Plasma

2 Autologous Conditioned Plasma Introduction Autologous blood products have created a growing interest for use in a number of orthopaedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a healing process wherever they are applied. Features and Benefits: More affordable, easier to use, and quicker procedure time when compared to other systems. Requires only 1cc of patient s blood, simplifying blood recovery from the patient. In vitro research has shown statistically improved tenocyte, chondrocyte, and osteoblast proliferation when cultured with vs. controls. The system does not concentrate inflammatory white or red blood cells, which can negatively interfere with the healing process. 8,9 Double Syringe Cap for Double Syringe Rotor with Buckets

3 Directions for use Procedure 1 2 Prior to withdrawing ACD-A, prime the innermost syringe by pulling it back and pushing it forward completely before starting the process. Withdraw approximately 1 ml ACD-A into the syringe. Caution: Draw back only the plunger of the outer syringe. Withdraw 9 ml of venous blood and seal the syringe with the red cap. 3 4 Gently rotate the syringe in order to mix the blood and the ACD-A. Place the syringe into one bucket and an appropriate Counterbalance in the opposite bucket.

4 5 6 Run the centrifuge at 11 RPM for 5 minutes. Remove the syringe, taking care to keep it in an upright position to avoid mixing the plasma and red blood cells. Slowly withdraw the plunger of the small inner syringe, in order to transfer 2-4 ml supernatant () from the larger outer syringe into the small inner syringe. Product and Ordering Information: 7 ABS-17 Anticoagulant ACD-A 4 ml ABS-11 / Double Syringe ABS-12 Centrifuge Hettich Rotofix 32 with Swing Out Rotor, 22 V ABS-122 Bucket with Screw Cap for ABS-11 / ABS-12 ABS-126 Counterweight Centrifugation Unscrew the small inner syringe and place an injection needle on to it. The is ready for use at the point of care.

5 Mechanism of action Outside the bloodstream, platelets become activated and release proliferative and morphogenic proteins. These growth factors are known to be relevant for healing in a variety of tissue types including bone, tendon, cartilage and skin. 1 Their main actions are: Induce proliferation and differentiation of various cell types (e.g., stem cell, osteoblast, epidermal cells) Enhance/modulate production of collagen, proteoglycan and Tissue Inhibitor of Metallo Proteinases (TIMP) Stimulate angiogenesis Chemotaxis These benefits seem to involve synergistic effects of growth factors. 2,3,4 In order to demonstrate the high levels of seven well documented common growth factors 2,5 in vs. whole blood, Arthrex prepared from the venous blood of 12 healthy donors and analyzed the concentration of the following growth factors: Factor Name Formation PDGF AB and BB Platelet-Derived Growth Factor Activated Thrombocytes TGF Beta 1 and Beta 2 Transforming Growth Factor Beta Activated Thrombocytes IGF Insulin-like Growth Factor Activated Thrombocytes EGF Epidermal Growth Factor Activated Thrombocytes VEGF Vascular Endothelial Growth Factor Leukocytes, Endothelium We found the density of platelets to be more than twice as high in the vs. whole blood. The concentration levels of all growth factors measured were significantly higher in the when compared to whole blood. The testing revealed an increase in concentration of 25x for PDGF-AB. The concentration was higher by a factor of 5 to 11 for EGF, VEGF, and PDGF BB and up to 5 for IGF 1, TGF ß1 and ß2. These concentrations are within the same order of magnitude when compared to the results in another study designed to determine growth factor levels in PRP. 5 High concentrations of growth factors like those found in the have been found to have regenerative and modulating effects on impaired cartilage or tendons. 6,7 Whole Blood x 1/uL pg/ml ng/ml Platelet EGF VEGF TGF-b2 IGF-I PDGF-AB PDGF-BB TGF-b1 25 Tenocyte Proliferation 5 Osteoblast Proliferation 25 Chondrocyte Proliferation DPM 15 1 DPM 3 2 DPM Negative Positive Negative Positive Negative Positive In order to determine the effect has on particular cell lines, in vitro, culture work was done on tenocytes, chondrocytes, and osteoblasts. Proliferation was measured for the following three culture groups: (1) negative control, cells cultured with 2% Fetal Bovine Serum (FBS); (2) positive/proliferative control, cells cultured with 1% FBS; and (3) cells cultured with. For each of the three cell lines, there was a statistically significant increase in proliferation for cells cultured with vs. controls.

6 References: 1 Richter W., Alternativen und Visionen zur Verbesserung der Knorpelregeneration, Trauma Berufskrankh., 22, 4, Borzini and Mazzucco (25) Borzini P and Mazzucco L, Tissue Regeneration and in Loco Administration of Platelet Derivates: Clinical Outcomes, Heterogeneous Products, and Heterogeneity of Effector Mechanisms; Transfusion, 25, 45, Edwards et al., Transforming Growth Factor Beta Modulates the Expression of Collagenase and Metalloproteinase Inhibitor, The EMBO Journal, 1987, 6, 7, Lynch et al., Role of Platelet-derived Growth Factor in Wound Healing: Synergistic Effects with other Growth Factors, Proc. Natl. Acad. Sci. USA, 1987, 84, Weibrich et al., Growth Factor Levels in PRP and Correlations with Donor age, sex, and Platelet Count, Journal of Cran-Max. Surgery, 22, 3, Mishra A. and Pavelko T., Treatment of Chronic Elbow Tendinosis with Buffered Platelet-Rich Plasma, The American Journal of Sports Medicine, 26, 34, 11, Sánchez et al., Comparison of Surgical Repaired Achilles Tendon Tears Using Platelet-Rich Fibrin Matrices, The American Journal of Sports Medicine, 27, 35, 2, Scott A, et al., What do we mean by the term inflammation? A contemporary basic science update for sports medicine, British Journal of Sports Medicine, 24; 38(3): Jiang N, et al., Respiratory protein generated reactive oxygen species as an antimicrobial strategy, Nature Immunology, 27; 8(1): Copyright Arthrex Inc., 27. All rights reserved. LABS-3 Vers. A...up-to-date technology just a click away This description of technique is provided as an educational tool and clinical aid to assist properly licensed medical professionals in the usage of specific Arthrex Vet Systems products. As part of this professional usage, the medical professional must use their professional judgment in making any final determinations in product usage and technique. In doing so, the medical professional should rely on their own training and experience and should conduct a thorough review of pertinent medical literature and the product s Directions For Use. 21, Arthrex Vet Systems. All rights reserved. VLB5 Vers. C