Upload
others
View
0
Download
0
Embed Size (px)
Citation preview
POB 2150, Holon 5885111, IsraelTel: +972 3 5596414, Fax: +972 3 5596424Email: [email protected]
SidE EFFEcTS and conTraindicaTionS
The autologous nature of PRP eliminates concerns for disease transmission and minimizes chances for possible side effects, which may be in a form of mild bruising, pain, swelling or infection. Standard skin disinfection should be used before PRP injection [23]. Contraindications include pregnancy, breast feeding, autoimmune or blood pathologies and cancer. Furthermore, use of NSAID drugs within 7 days prior to and 5 weeks after TROPOCELLS® PRP should be avoided [23].
References:
FEaTurES and BEnEFiTS oF ThE TroPocELLS® PrP SySTEmEffectiveness•TheTropocells®systemenableshighplateletyield•Rapidandsimplepreparationprocesswithasingle10-minutesspintime•CustomizablePlateletConcentrationforspecificclinicalapplications•Speciallydesignedaccessoriesforoperationroomsetting.
Safety and Quality•Closed,biocompatibleandxeno-freesystemminimizingsafetyconcerns.•ApprovedmedicaldevicebytheEuropean(CE)andUSA(FDA)RegulatoryAuthorities(FDAclearancefororthopedicapplicationsonly).
•Manufacturedincleanrooms,underENISO13485:2003,ISO9001:2008QualitySystemInternationalStandards.
1. Platelet-rich plasma: a review of biology and applications in plastic surgery.Eppley BL et al. Plast Reconstr Surg. 20062. Platelet Rich Plasma. A New Treatment Tool for the Rheumatologist? De La Mata. Reumatol Clin. 20133. The effect of thrombin activation of platelet-rich plasma on demineralized bone matrix osteoinductivity.Han B et al. J Bone Joint Surg Am. 20094. Positive effect of an autologous platelet concentrate in lateral epicondylitis in a double-blind randomized controlled trial: platelet rich plasma versus corticosteroid injection with a 1-year follow-up.Peerbooms JC et al. Am J Sports Med. 20105. Platelet-rich plasma versus autologous whole blood for the treatment of chronic lateral elbow epicondylitis: a randomized controlled clinical trial.Thanasas C et al. Am J Sports Med. 20116. Platelet rich plasma in arthroscopic rotator cuff repair: a prospective RCT study, 2-year follow-up.Randelli P et al. J Shoulder Elbow Surg. 20117. Platelet-rich plasma vs hyaluronic acid to treat knee degenerative pathology: study design and preliminary results of a randomized controlled trial.Filardo G et al. BMC Musculoskelet Disord. 20128. Patellar tendon healing with platelet-rich plasma: a prospective randomized controlled trial.De Almeida AM et al. Am J Sports Med. 20129. Platelet-Rich Plasma Versus Focused Shock Waves in theTreatment of Jumper's Knee in Athletes.Vetrano M et al. AJSM. 201310. Role of platelet-rich plasma in combination with alloplastic bone substitute in regeneration of osseous defects.Singh I et al. J Oral Biol Craniofac Res. 201111. Regeneration of human bones in hip osteonecrosis and human cartilage in knee osteoarthritis with autologousadipose-tissue-derived stem cells: a case series.Pak J. J Med Case Rep. 201112. Application of platelet-rich plasma accelerates the wound healing process in acute and chronic ulcers through rapid migration and upregulation of cyclin A and CDK4 in HaCaT cells.Kim SA et al. Mol Med Rep. 201313. Efficacy of intradermal radiofrequency combined with
autologous platelet-rich plasma in striae distensae: a pilot study.Kim IS et al. Int J Dermatol. 201214. Platelet-Rich Plasma Induces Increased Expression of G1 Cell Cycle Regulators, Type I Collagen, and Matrix Metalloproteinase-1 in Human Skin Fibroblasts.Cho JW et al. Int J Mol Med. 201215. Using objective criteria to evaluate cosmetic effects of platelet rich plasma.Amgar G et al. Prime 201116. Platelet rich plasma (PRP) for facial rejuvenation.Zenker S. J. Méd. Esth. et Chir. Derm. 201017. A randomized, double-blind, placebo and active-controlled, half-head study to evaluate the effects of platelet rich plasma on alopecia areata.Trink A et al. BJD 201318. Platelet-Rich Plasma: A Therapy For Hair Growth.Amgar G and Bouhanna P. Prime 201319. Autologous PRP Injection in Androgenic Alopecia. Amgar G and Bouhanna P. Prime 201520. Growth Factor and Catabolic Cytokine Concentrations Are Influenced by the Cellular Composition of Platelet-Rich Plasma.Sundman EA et al. Am J Sports Med. 201121. Red Blood Cells Inhibit Proliferation and Stimulate Apoptosis in Human Lung Fibroblasts In Vitro.Fredriksson K et al. Scand J Immunol. 200422. Peripheral Blood Mononuclear Cells Enhance the Anabolic Effects of Platelet-Rich Plasma on Anterior Cruciate Ligament Fibroblasts.Yoshida R et al. J Orthop Res. 201323. ICMS Guidelines, Section VIII Platelet Rich Plasma (PRP).Guidelines, 2011
Platelet-Rich Plasma (PRP) Therapy
ADVANCEREPAIRREST RE
www.estar-medical.com
YOUR BODY'S ABILITY
IN A NATURAL WAY
http://www.tropocells.com
cat. 7 ver.3
®
uniquE BioLogicaL ProFiLE The specially-designed Tropocells Separator Gel produces an optimum PRP profile:•Lowgranulocytes:PMNsarenotconsideredbeneficialintermsofregenerationprocessandmaycontributetoacataboliceffectbysecretingcatabolicmediators,includingmetalloproteinases[20].
•VirtuallyeliminatinggranulocytesfromPRP,whicharenotconsideredbeneficial intermsofregenerationprocessandmaycontributetoacataboliceffectbysecretingcatabolicmediators,includingmetalloproteinases[20].
•LowRBCs:erythrocyteshavebeenshowntosignificantlydecreasefibroblastproliferationandaugmentapoptosisinvitro[21].•HighMonocytes:MononuclearcellspresentinPRPassistinfightinginfection.•IncreasingcollagenexpressionandenhanceanaboliceffectsofPRP[22].•HighPlateletYield:Aproprietaryanticoagulantandspecializedtubecoatinghelpmaximizeplateletyieldsoalowervolumeofbloodisneeded.
advanTagES oF PrP ThEraPy in orThoPEdicS & SPorS mEdicinE•PRPinitiatesconnectivetissuehealing,boneandjointsurfaceregenerationandrepair,promotesdevelopmentofnewbloodvesselsandstimulateswoundhealing.
•PRPprovidessignificantimprovementinsymptoms•Minimalsafetyconcerns–PRPisaverysafeprocedure;itisnon-allergenicandwithoutriskoftransmissiblediseases.
•PRPaccelerateshealingandmaydelayoreliminatetheneedforsurgery.
•Maybecombinedwithothertreatmentstostimulatebiologicalhealingeffects.
Shoulder• Rotator cu� tendonitis and partial tears• Rotator cu� repair• Cartilage defects and early arthritis• SLAP lesion
Elbow• Lateral epicondylitis• Medial epicondylitis
Back & Hip• Facet joint arthritis• Sacroiliac joint pain• Hip girdle muscle pain• Hamstring tendonitis
Knee• Patellar tendonitis• Meniscus• Ligament (MCL, LCL, ACL, PCL)• Cartilage defects
Ankle & Foot• Plantar Fasciitis• Achilles tendonitis• Ankle sprains
Wrist & Hand• Ligament sprains• TFCC
What is Platelet-Rich Plasma?Platelet-RichPlasma(PRP)isaninnovativeandpromisingapproachintissueregeneration.PRPisdefinedasanautologousconcentratedpreparationofplatelets inasmallvolumeofplasma[1].PRPowesitstherapeuticinteresttothecrucial instrumentalroleofgrowthfactorsreleasedbyplateletsgranuleswhichpossessmultipleregenerativeproperties.TheautologousnatureofTropocells®PRPguaranteesitsexcellentsafetyprofile[2].
Therapeutic Effect of PRPPRPisthoughttopromotephysiologicalhealingandrapidsoftandhardtissueregenerationbydeliveringhighconcentrationsofgrowthfactorsessentialforconnectivetissuehealing;regeneratingandrepairingbone,tendon,cartilageandligament;promotingdevelopmentofnewbloodvesselsandstimulatingwoundhealing.
PRP Growth FactorsUponactivation,platelets releasegrowth factors,cytokinesandotherbioactiveproteins,which are part of the natural healing process. These growth factors are regeneration-associatedsignalingmolecules,suchasPlatelet-DerivedGrowthFactor(PDGF),TransformingGrowthFactorgroup(TGF),EpidermalGrowthFactor (EGF),VascularEndothelialGrowthFactor (VEGF),FibroblastGrowthFactor (FGF)andothers.Thesegrowth factorscontrolandregulatethehealingcascade,byexertingtheireffectson inflammatoryprocess,cellproliferation,reepithelialization,angiogenesis,woundhealing,collagenproductionandothertissueremodelingprocesses[1-2].
Platelet ActivationPlateletsmay be activated via addition of activating substances, such as thrombin andcalciumchloride.However,Ithasbeenpostulatedthatinsituactivationofplatelets(causedbyinjection;uponcontactwithconnectivetissueandexposuretoinsitucoagulationfactors,suchascollagen),thecellmembraneoftheplatelet is"activated"toreleasethesealphagranules,resultinginaslowreleasepatternofgrowthfactorssecretion,whichisbeneficialforstimulatingacontinuoushealingresponse[3].
PRP ApplicationsPRP’ssafetyandeffectivenesshavebeenestablishedforacceleratingsoftandhardtissuehealingintreatmentoftendinopathies[4-6],osteoarthritis[7]andvariousjointandmusclepathologiesinOrthopaedicsandSportsMedicine[8,9*].PRPmaybeusedasastandalonetreatmentorasabiologicaladjuncttootherbiomaterials,suchasbonesubstitutes[10],hyaluronicacid,collagenandstemcells[11].Moreover,PRPhasbeenusedextensivelyfortreatingchronicwounds[12*,13*,14*],inPlastic[1,13*],OralandMaxillofacialsurgery[10],SkinRejuvenation[15*,16*]andHairRestoration[17,18*,19*]
*PublicationswithEstarMedical'sdeviceforPRPpreparation.
PRP PRePARAtion usinG tRoPocells® PRPPRPispreparedbytakingasmallsampleofthepatient’sownblood,thenseparatingplateletsfromPlatelet-PoorPlasma(PPP),RedBloodCells(RBC)andleukocytesviacentrifugation.PRPisthencollectedandcanbeinjectedbackintothetreatedsitetopromotehealingresponse.Thewholepreparationprocessissimpleandtakesupto15minutes.
tropocells® PRP – 2ml
Plateletsconcentrationfold
RBC(106/ul)
WBC(103/ul)
Granulocytes%
Mononuclearcells%
PDGF(pg/ml)
VEGF(pg/ml)
EGF(pg/ml)
X4-5
0.0
0.2
8.5
86.2
2048
220
269
HematologicalanalysesofPRPvs.wholeblood.(A-B)Stainedwholebloodsmearscontainingnumerouserythrocytesandleukocytes.Conversely,PRPsmears(C,D)containprimarilyplatelets(arrow),whiletheerythrocytesandgranulocytesareeliminated.
Ax40
Bx100
Cx40
Dx100
1
CollectblooddirectlyintoTropocells PRPvacuumtubecontainingseparationgelandanticoagulant
RemoveaportionofPPPtoachievehigherplateletconcentration(optional)
DrawPRPforuseResuspendplateletsintheremainingplasmatogeneratePRPbyinvertingtheliquidafewtimesagainstthetubewall
AnticoagulantGel
WholeBlood & Anticoagulant
GelseparatesplateletsfromPPP,RBCandgranulocytes.Plateletsresideontopofthegel.Inserttheventedneedleintothetube
Centrifugefor10minat1500g.
2
5
3
64
PRPPlatelet layer
GelRBC
PPP
GELRBC
PRP
Gel
PPP
Platelet layerGel
RBC
X 20
Tropocells®PRPisaregisteredtrademarkofEstarTechnologiesLtd.T-578646-10-INPatentedbyEstarTechnologiesLtd.P-570257-US//P-570201-US//P-570201-IL//P-570257-IL
Tropocells®PRPpreparation
TheperformancetestswerecarriedoutaccordingtotheU.S.FDArequirementsforPlateletsRichPlasmamedicaldevices.