運動醫(yī)學(xué)-翻譯已較42242中文

ChondroCelect?

因循證，而不同Prof.Dr.Em.ReneVERDONKGhentUniversityHospitalBelgiumProductauthorizationnumberEU/1/09/563/001MedicinalproductauthorizedwithinEuropeanUnion

PleaseseefullprescribinginformationforChondroCelectatbooth#1什么是chondrocelect

?ProductauthorizationnumberEU/1/09/563/001MedicinalproductauthorizedwithinEuropeanUnion

PleaseseefullprescribinginformationforChondroCelectatbooth#1ChondroCelect?

是一種

基于自體軟骨細胞制備的醫(yī)藥產(chǎn)品基于自體細胞的醫(yī)療產(chǎn)品EU/1/09/563/001自體軟骨細胞經(jīng)體外培育擴增表達特異標(biāo)記蛋白

移植用細胞懸液(0,4ml細胞懸液;4百萬細胞)ProductauthorizationnumberEU/1/09/563/001MedicinalproductauthorizedwithinEuropeanUnion

PleaseseefullprescribinginformationforChondroCelectatbooth#1ChondroCelect?

修復(fù)膝關(guān)節(jié)軟骨

適用于修復(fù)成人膝關(guān)節(jié)股骨髁的單個有癥狀的軟骨損傷

(國際軟骨修復(fù)學(xué)會[ICRS]分級III或IV)

同時可用于伴隨的無癥狀的軟骨損傷

(國際軟骨修復(fù)學(xué)會[ICRS]分級I或II)GradeICRSIII病損超過關(guān)節(jié)軟骨的一半厚度IV病損達到軟骨下骨4SmPC.患者選擇

基于隨機對照研究及體恤用藥計劃中收集的數(shù)據(jù)：

膝關(guān)節(jié)股骨髁的單個有癥狀的軟骨損傷

(國際軟骨修復(fù)學(xué)會[ICRS]分級III或IV)病損最大為15cmVanlauwe,Sarisetal.,AJSM2011SmPCChondroCelect?

治療流程459-13weeksCRYOPRESERVATION治療技術(shù)的靈活性細胞懸液在縫合的生物膜下注射Brittberg技術(shù)預(yù)植細胞生物膜縫合修復(fù)預(yù)植細胞生物膜非縫合修復(fù)Brittbergetal.,NEJM1994Steinwachsetal.,Cartilage2012細胞種植技術(shù)EVIDENCE隨機對照研究體恤用藥計劃授權(quán)后登記ChondroCelect一個新的循證醫(yī)學(xué)標(biāo)準(zhǔn)?Saris,Vanlauweetal.,AJSM2008隨機對照研究

結(jié)構(gòu)性修復(fù)效果優(yōu)于微骨折技術(shù)（MF）

Vanlauwe,Sarisetal.,AJSM2011隨機對照研究早期治療極為重要比利時/荷蘭患者登記系統(tǒng)

軟骨病損特征至2013.09.05登記情況軟骨病損大小分布情況*Meanage:32years(range:15-51years)Malegender:64%Averagelesionsize:4.73cm2(range:2-11cm2)Patientnumber:BelNethPooleddataset#patientsentered

inthestudy8011522232#patientswithBLand/orfollow-upKOOSdata8011423222#patientswithBLvalue53111164#patientswithBLvalueand≥

1follow-upKOOSpoint(statisticsdataset*)2264861Onepatienthadbothkneestreated2Fivepatientshadbothkneestreated3ThreepatientshadbothkneestreatedPosterpresentedatOrthopedicaBelgica2014比利時/荷蘭患者登記系統(tǒng)

效果與效力登記患者的KOOS4#評分情況

(患者癥狀出現(xiàn)<3年)隨機對照研究患者的KOOS4#評分情況(患者癥狀出現(xiàn)<3年)****p<0.05

ChondroCelect?(n=29)

Microfracture(n=35)Vanlauwe,Sarisetal.,AJSM2011PosterpresentedatOrthopedicaBelgica2014比利時/荷蘭患者登記系統(tǒng)

KOOS子域評分改善情況#atleasta10pointsimprovementfrombaseline,asdescribedbyRoosE.M.andLohmanderL.S.HealthQualLifees.

2003,

1:64KOOS子域評分變化情況time(months)MeanscoreKOOSimprovementvs.BLTime(months)PosterpresentedatOrthopedicaBelgica2014比利時/荷蘭患者登記系統(tǒng)

患者性別及軟骨病損大小軟骨病損大小對于KOOS4評分的影響time(months)Meanscore性別對于KOOS4評分的影響time(months)MeanscoreWesoughttobetterdefinewhichcapturedpatientandlesionparametersmayinfluencees.Neithergendernorlesionssizeseemtoimpactfunctionalresultssofar.Ofnote,thenumberofpatientforwhomlong-termfollow-upisavailabledidnotmakeitpossibletoanalysetheimpactofpatientagethistimearound(only2patients>34yearsofageatthe24-monthtimepointinthestatisticsdataset).PosterpresentedatOrthopedicaBelgica2014比利時/荷蘭患者登記系統(tǒng)

癥狀嚴(yán)重程度與療效KOOS疼痛評分>55的患者KOOS評分情況(53.5%患者;平均病損大小:5.00cm2)KOOS疼痛評分<55的患者KOOS評分情況

(46.5%患者;平均病損大小:4.84cm2)time(months)Meanscoretime(months)Meanscore?SarisDBetal.,AmJSportsMed.

2014Apr8.[Epubaheadofprint]KOOSTime(months)Time(months)KOOSPosterpresentedatOrthopedicaBelgica2014縱觀隨機對照研究、體恤用藥計劃及登記系統(tǒng)

ChondroCelect安全性證明Treatmentfailureseatmentfailurewasdefinedastheneedforare-interventionaffectingmorethan20%ofthesurfaceoftheindexlesion.5patientswithtreatmentfailurewerereportedinthestudy.FourtreatmentfailureswereconsideredtobepossiblyrelatedtoChondroCelect?(1.7%ofalltreatedknees),andonecasewasconsiderednotrelatedtoChondroCelect?.Adverseevents:Atotalof67AdverseEvents(AEs)and7treatment-emergingseriousAEshadbeenreportedbydatalockpoint.TwoAEsoccuredin>3%ofthe238kneestreated(jointswelling:6.7%;kneepain:4.2%).ComparedtothepreviouslypublisheddataonChondroCelect?’spivotalRCTandcompassionateuseprogram,thenumberofreportedAEsthatwereconsideredatleastpossiblyrelatedtothestudyprocedure(adversereactions)wasrelativelylow(seeTable2).ApossibleexplanationforthisoveralllownumberofAEs,besidethecross-sectionnalnatureofthisinterimanalysis,isthatpatientselectionwasguidedbystrictreimbursementconditionsthatarewithinthescopeoftheSmPCindicationbutstricterinthattheyarelimitedtoarecentsinglelesionofthefemoralcondyle.Adversereactions

reportedpost-operatively1,2TIGACT01CUP3,4SmPCRegistry4Totalnr

of

patients51334-232Cartilage

hypertrophy14(27%)54(1.2%)≥10%2(0.8%)Jointcrepitation10(20%)9(2.7%)≥10%2(0.8%)Jointswelling7(14%)2(0.6%)≥10%2(0.8%)Jointeffusion6(11%)7(2.1%)≥1to<10%1(0.4%)Treatmentfailure

(related)4(7.8%)7(2.1%)≥1to<10%4(1.7%)Delamination3(5.9%)1(0.3%)≥1to<10%0Subchondralboneinjury2(3.9%)2(0.6%)≥1to<10%01.AnAEiscountedonlyonceperpatient;2.OnlyAEsconsideredrelatedtothestudyprocedure(surgery&ChondroCelect)bytheinvestigator;

3.Safetypopulation;4.onlyChondroCelect-relatedAEs;5.InthepivotalRCT,aperiostalflapwasusedtocoverthelesionbeforeimplantingChondroCelect.Latertria