ACTUALITATI IN TERAPIA SCLEROZEI MULTIPLE Caciulata 2007 Dr. Damian Irene Spitalul Clinic CF...

ACTUALITATI IN TERAPIA ACTUALITATI IN TERAPIA SCLEROZEI MULTIPLESCLEROZEI MULTIPLE

Caciulata 2007Caciulata 2007

Dr. Damian Irene Dr. Damian Irene

Spitalul Clinic CF ConstantaSpitalul Clinic CF Constanta

Tratamentul actual standardizat al SM Tratamentul actual standardizat al SM (prevazut in ghidurile de practica medicala, in urma validarii (prevazut in ghidurile de practica medicala, in urma validarii eficacitatii si al profilului lor de siguranta prin studii clinice, eficacitatii si al profilului lor de siguranta prin studii clinice,

conform principiilor medicinei bazate pe dovezi):conform principiilor medicinei bazate pe dovezi):

• 1. Tratamente care modifică evoluţia bolii1. Tratamente care modifică evoluţia bolii

În prezent, pe plan internaţional sunt acceptate ca fiind medicamente care modifică În prezent, pe plan internaţional sunt acceptate ca fiind medicamente care modifică evoluţia bolii următoarele: evoluţia bolii următoarele:

1.1. Imunomodulatoare:1.1. Imunomodulatoare:A. Interferonii beta:A. Interferonii beta:

• interferonul beta la (REBIF), cu administrare s.c. 3 doze pe săptămânăinterferonul beta la (REBIF), cu administrare s.c. 3 doze pe săptămână• interferonul beta la (AVONEX), cu administrare i.m. 1 doză pe săptămânăinterferonul beta la (AVONEX), cu administrare i.m. 1 doză pe săptămână• interferonul beta lb (BETAFERON), cu administrare s.c, 1 doză la 2 zileinterferonul beta lb (BETAFERON), cu administrare s.c, 1 doză la 2 zile

B. Glatiramerul acetat ( COPAXONE ), B. Glatiramerul acetat ( COPAXONE ), cu administrare s.c. câte o doză în cu administrare s.c. câte o doză în fiecare zi fiecare zi

1.2. Imunosupresoare:1.2. Imunosupresoare: mitoxantrona (Novantrone)mitoxantrona (Novantrone)

Alte forme de tratament imunosupresor care pot fi folosite în tratamentul Alte forme de tratament imunosupresor care pot fi folosite în tratamentul

sclerozei multiple în situaţii particulare nu sunt încadrate şi înregistrate de către sclerozei multiple în situaţii particulare nu sunt încadrate şi înregistrate de către

autorităţile naţionale şi internaţionale, în concordanţă cu rezultatele studiilor clinice autorităţile naţionale şi internaţionale, în concordanţă cu rezultatele studiilor clinice

desfăşurate până în prezent, ca agenţi care modifică evoluţia bolii. desfăşurate până în prezent, ca agenţi care modifică evoluţia bolii.

Tratamentul actual standardizat al SMTratamentul actual standardizat al SM

• Alte tratamente imunomodulatoare (imunoglobulina G administrate i.v., Alte tratamente imunomodulatoare (imunoglobulina G administrate i.v., anticorpii monoclonali-natalizumab) sau imunosupresoare (azatioprina, anticorpii monoclonali-natalizumab) sau imunosupresoare (azatioprina, metotrexatul, ciclofosfamida, cladribina, ciclosporina, etc.) nu au metotrexatul, ciclofosfamida, cladribina, ciclosporina, etc.) nu au demonstrat cert, până în prezent, prin studii controlate, eficacitatea în demonstrat cert, până în prezent, prin studii controlate, eficacitatea în sensul modificării favorabile a evoluţiei SM. De aceea, ele pot fi folosite în sensul modificării favorabile a evoluţiei SM. De aceea, ele pot fi folosite în cazuri individuale în care medicul îşi asumă responsabilitatea indicaţiei, a cazuri individuale în care medicul îşi asumă responsabilitatea indicaţiei, a supravegherii siguranţei şi eficacităţii tratamentului.supravegherii siguranţei şi eficacităţii tratamentului.

• 2. Tratamentul puseului : corticoizi2. Tratamentul puseului : corticoizi

(scad durata şi severitatea puseului şi numărul de leziuni captante de (scad durata şi severitatea puseului şi numărul de leziuni captante de

gadolinium la examenul IRM cerebral; gadolinium la examenul IRM cerebral; folosirea lor însă nu diminuează folosirea lor însă nu diminuează

invaliditatea acumulată prin pusee repetate.)invaliditatea acumulată prin pusee repetate.)

• MetilprednisolonMetilprednisolon în doze mari: 1 gr i.v. în 1-2 h zilnic, timp de 3-5 zile. în doze mari: 1 gr i.v. în 1-2 h zilnic, timp de 3-5 zile.

Cele mai multe protocoale întrerup apoi, brusc, corticoterapia. Cele mai multe protocoale întrerup apoi, brusc, corticoterapia.

• DexametazonaDexametazona: 8-12 mg i.v. la 8-12 ore timp de 3-7 zile, urmată de : 8-12 mg i.v. la 8-12 ore timp de 3-7 zile, urmată de

administrare oralăadministrare orală

Tratamentul actual standardizat al SMTratamentul actual standardizat al SM

• 3. Tratamentul simptomatic şi recuperator 3. Tratamentul simptomatic şi recuperator

• Tratamentul simptomatic şi recuperator are ca scop general Tratamentul simptomatic şi recuperator are ca scop general ameliorarea calităţii vieţiiameliorarea calităţii vieţii

pacienţilor cu SM, cu menţinerea integrării lor sociale cât mai mult timp posibil. El este adaptat în pacienţilor cu SM, cu menţinerea integrării lor sociale cât mai mult timp posibil. El este adaptat în

funcţie de funcţie de stadiul clinicstadiul clinic al bolii şi de al bolii şi de gradul de invalidaregradul de invalidare caracteristic fiecărui pacient şi se caracteristic fiecărui pacient şi se

adresează diferenţiat fiecărui aspect clinic al bolii: adresează diferenţiat fiecărui aspect clinic al bolii: invalidarea motorieinvalidarea motorie, , disfuncţia sfincterianădisfuncţia sfincteriană, ,

dificultăţile de comunicaredificultăţile de comunicare, , afectarea cognitivăafectarea cognitivă, , disfuncţiile emoţionaledisfuncţiile emoţionale etc etc

• ObiectiveleObiectivele acestor măsuri sunt: prevenirea acestor măsuri sunt: prevenirea complicaţiilor complicaţiilor bolii, diminuarea bolii, diminuarea handicapuluihandicapului şi şi limitarea limitarea dependenţeidependenţei pacientului prin optimizarea utilizării resurselor fizice şi psihologice restante pacientului prin optimizarea utilizării resurselor fizice şi psihologice restante

• Cele mai frecvente simptome asociate sclerozei multiple sunt:Cele mai frecvente simptome asociate sclerozei multiple sunt:

• tulburările sfincteriene şi de tranzit intestinaltulburările sfincteriene şi de tranzit intestinal• oboseală cronicăoboseală cronică• spasticitatea şi contracţiile spasticespasticitatea şi contracţiile spastice• durereadurerea• disfuncţiile cognitivedisfuncţiile cognitive• depresiadepresia• tremorul şi tulburările de echilibrutremorul şi tulburările de echilibru• disfuncţiile sexualedisfuncţiile sexuale• simptomele paroxistice şi tulburările motorii simptomele paroxistice şi tulburările motorii

Studii clinice privind etio-patogenia si terapia SM, Studii clinice privind etio-patogenia si terapia SM, aflate in desfasurare la aceasta data: 155 studiiaflate in desfasurare la aceasta data: 155 studii

Cele mai semnificative studii aflate in curs de desfasurare la nivel Cele mai semnificative studii aflate in curs de desfasurare la nivel mondial, in scopul validarii unor noi posibilitati terapeutice in SM:mondial, in scopul validarii unor noi posibilitati terapeutice in SM:

• 1.1.RecruitingRecruitingCombination Therapy in Patients With Relapsing-Remitting Multiple SclerosiCombination Therapy in Patients With Relapsing-Remitting Multiple Sclerosis (s (MS)CombiRxMS)CombiRxCondition: Relapsing Remitting Multiple SclerosisCondition: Relapsing Remitting Multiple Sclerosis

• 2.2.RecruitingRecruitingSafety Study of RTL1000 (Recombinant T Cell Receptor Safety Study of RTL1000 (Recombinant T Cell Receptor LigandLigand) in Subjects With Multiple Sclerosis) in Subjects With Multiple SclerosisConditions: Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis, Conditions: Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis, Relapsing-RemittingRelapsing-Remitting

• 3.3.RecruitingRecruitingEfficacy and Safety of MBP8298 in Subjects With Secondary Progressive MuEfficacy and Safety of MBP8298 in Subjects With Secondary Progressive Multiple Sclerosisltiple Sclerosis

Condition: Multiple Sclerosis, Secondary ProgressiveCondition: Multiple Sclerosis, Secondary Progressive• 4.4.RecruitingRecruitingSafety/Effectiveness of Adding Monthly Safety/Effectiveness of Adding Monthly DexamethasoneDexamethasone

to Weekly to Weekly AvonexAvonex for MS for MSConditions: Relapsing-Remitting Multiple Sclerosis,; Mono-Symptomatic Conditions: Relapsing-Remitting Multiple Sclerosis,; Mono-Symptomatic Multiple SclerosisMultiple Sclerosis

• 8.8.RecruitingRecruitingA A RandomisedRandomised Controlled Trial of Controlled Trial of NeuroprotectionNeuroprotection With With LamotrigineLamotrigine in Secondary Progressive Multiple Sclerosis in Secondary Progressive Multiple SclerosisCondition: Secondary Progressive Multiple SclerosisCondition: Secondary Progressive Multiple Sclerosis

• 9.9.RecruitingRecruitingEvaluation of Efficiency of Ritalin in Multiple Sclerosis (MS) PatientsEvaluation of Efficiency of Ritalin in Multiple Sclerosis (MS) PatientsConditions: Relapsing Remitting Multiple Sclerosis; Multiple Sclerosis, Conditions: Relapsing Remitting Multiple Sclerosis; Multiple Sclerosis, Chronic ProgressiveChronic Progressive

http://clinicaltrials.gov/ct/show/NCT00211887?order=1





















Studii clinice privind etio-patogenia si terapia SM, Studii clinice privind etio-patogenia si terapia SM, aflate in desfasurare la aceasta dataaflate in desfasurare la aceasta data

• 10.10.RecruitingRecruitingA Safety Study of Combination Treatment With A Safety Study of Combination Treatment With AvonexAvonex and Placebo-Controlled Dosing of and Placebo-Controlled Dosing of TopamaxTopamax in Relapsing-Remitting Multiple Sclerosis in Relapsing-Remitting Multiple SclerosisCondition: Multiple SclerosisCondition: Multiple Sclerosis

• 11.11.Not yet recruitingNot yet recruitingMesenchymalMesenchymal Stem Cells in Multiple Sclerosis (MSCIMS) Stem Cells in Multiple Sclerosis (MSCIMS)Condition: Multiple SclerosisCondition: Multiple Sclerosis

• 12.12.RecruitingRecruitingEfficacy and Safety of Efficacy and Safety of FingolimodFingolimod (FTY720) in Patients With Relapsing-Remitting Multiple Sclerosis (FTY720) in Patients With Relapsing-Remitting Multiple SclerosisCondition: Multiple SclerosisCondition: Multiple Sclerosis

• 13.13.RecruitingRecruitingTrial of Trial of MemantineMemantine for Cognitive Impairment in Multiple Sclerosis for Cognitive Impairment in Multiple SclerosisConditions: Multiple Sclerosis; Cognition DisordersConditions: Multiple Sclerosis; Cognition Disorders

• 18.18.RecruitingRecruitingTCV -01-002: T-Cell Vaccination in the Treatment of Probable Multiple SclerosiTCV -01-002: T-Cell Vaccination in the Treatment of Probable Multiple Sclerosiss

Condition: Multiple SclerosisCondition: Multiple Sclerosis• 19.19.RecruitingRecruitingAtorvastatin (Atorvastatin (LipitorLipitor

) Therapy in Patients With Clinically Isolated Syndrome (CIS) at Risk for Multip) Therapy in Patients With Clinically Isolated Syndrome (CIS) at Risk for Multiple Sclerosisle Sclerosis

Condition: Multiple SclerosisCondition: Multiple Sclerosis• 21.21.RecruitingRecruiting

Study of SB-683699 Compared to Placebo in Subjects With Relapsing-RemittiStudy of SB-683699 Compared to Placebo in Subjects With Relapsing-Remitting Multiple Sclerosis (MS)ng Multiple Sclerosis (MS)

Condition: Relapsing Remitting Multiple SclerosisCondition: Relapsing Remitting Multiple Sclerosis• 26.26.RecruitingRecruiting

Brain Peripheral Benzodiazepine Receptors in Patients With Multiple SclerosisBrain Peripheral Benzodiazepine Receptors in Patients With Multiple SclerosisCondition: Multiple SclerosisCondition: Multiple Sclerosis























Studii clinice privind etio-patogenia si Studii clinice privind etio-patogenia si terapia SM, aflate in desfasurare la aceasta terapia SM, aflate in desfasurare la aceasta datadata

• 27.27.RecruitingRecruitingSimvastatin as an Add-on Treatment to Interferon-Beta-1a for the Treatment oSimvastatin as an Add-on Treatment to Interferon-Beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosisf Relapsing-Remitting Multiple Sclerosis


Cranberry for Prevention of Urinary Tract Infections in Multiple Sclerosis PatienCranberry for Prevention of Urinary Tract Infections in Multiple Sclerosis Patientsts

Conditions: Multiple Sclerosis; Urinary Tract Infections; Bladder DysfunctionConditions: Multiple Sclerosis; Urinary Tract Infections; Bladder Dysfunction• 31.31.RecruitingRecruitingUse of Use of CannabinoidsCannabinoids in Patients With Multiple Sclerosis in Patients With Multiple Sclerosis


Efficacy of 3,4-DAP in Fatigue Associated With Multiple SclerosisEfficacy of 3,4-DAP in Fatigue Associated With Multiple SclerosisCondition: Multiple SclerosisCondition: Multiple Sclerosis

• 33.33.RecruitingRecruitingSafety and Efficacy of Safety and Efficacy of CellceptCellcept and and AvonexAvonex as Combination Treatment in Multiple Sclerosis as Combination Treatment in Multiple SclerosisCondition: Multiple SclerosisCondition: Multiple Sclerosis

• 34.34.RecruitingRecruitingDonor Stem Cell Transplantation for the Treatment of Multiple SclerosisDonor Stem Cell Transplantation for the Treatment of Multiple SclerosisCondition: Multiple SclerosisCondition: Multiple Sclerosis

• 35.35.RecruitingRecruitingVisual Impairment, Visual Impairment, OscillopsiaOscillopsia and Multiple Sclerosis and Multiple SclerosisCondition: Multiple SclerosisCondition: Multiple Sclerosis

• 36.36.Not yet recruitingNot yet recruitingTrialTrial of Analgesia With of Analgesia With LidocaineLidocaine or Extended-Release or Extended-Release OxycodoneOxycodone for for NeuropathicNeuropathic Pain Treatment in Multiple Sclerosis Pain Treatment in Multiple SclerosisConditions: Neuropathic Pain; Chronic Pain; Multiple SclerosisConditions: Neuropathic Pain; Chronic Pain; Multiple Sclerosis


























Studii clinice privind etio-patogenia si Studii clinice privind etio-patogenia si terapia SM, aflate in desfasurare la aceasta terapia SM, aflate in desfasurare la aceasta

datadata• 41.41.RecruitingRecruiting

POPART'MUS: Prevention of Post Partum Relapses With Progestin and POPART'MUS: Prevention of Post Partum Relapses With Progestin and EstradiolEstradiol in Multiple Sclerosis in Multiple SclerosisCondition: Multiple SclerosisCondition: Multiple Sclerosis

• 42.42.Not yet recruitingNot yet recruitingSafetySafety and Efficacy Study of and Efficacy Study of DaclizumabDaclizumab HYP to Treat Relapsing-Remitting Multiple Sclerosis HYP to Treat Relapsing-Remitting Multiple SclerosisCondition: Multiple Sclerosis, Relapsing-RemittingCondition: Multiple Sclerosis, Relapsing-Remitting

• 45.45.RecruitingRecruitingStudy of Study of FampridineFampridine-SR Tablets in Multiple Sclerosis Patients-SR Tablets in Multiple Sclerosis PatientsCondition: Multiple SclerosisCondition: Multiple Sclerosis

• 46.46.RecruitingRecruitingEfficacy and Safety Evaluation of Efficacy and Safety Evaluation of NabiloneNabilone as Adjunctive Therapy to as Adjunctive Therapy to GabapentinGabapentin for the Management of for the Management of NeuropathicNeuropathic Pain in Multiple Sclerosis Pain in Multiple SclerosisConditions: Neuropathic Pain; Multiple SclerosisConditions: Neuropathic Pain; Multiple Sclerosis

• 50.50.RecruitingRecruitingAspirin for Treatment of Multiple Sclerosis-Related FatigueAspirin for Treatment of Multiple Sclerosis-Related FatigueCondition: Multiple SclerosisCondition: Multiple Sclerosis

• 53.53.RecruitingRecruitingIPX056 in Subjects With Established IPX056 in Subjects With Established SpasticitySpasticity Resulting From Multiple Sclerosis Resulting From Multiple SclerosisCondition: Multiple SclerosisCondition: Multiple Sclerosis

• 54.54.RecruitingRecruitingSafety and Tolerability of Interferon-Beta-1a and Safety and Tolerability of Interferon-Beta-1a and EstroprogestinsEstroprogestins Association in MS Patients Association in MS PatientsCondition: Multiple SclerosisCondition: Multiple Sclerosis

• 56.56.RecruitingRecruitingNeuropathic Pain Assessment Comparing Neuropathic Pain Assessment Comparing PregabalinPregabalin and and ParoxetineParoxetine in Management of MS-Induced in Management of MS-Induced NeuropathicNeuropathic Pain PainConditions: Neuropathic Pain; Multiple SclerosisConditions: Neuropathic Pain; Multiple Sclerosis

• 58.58.RecruitingRecruitingNatalizumab Re-Initiation of DosingNatalizumab Re-Initiation of DosingCondition: Multiple Sclerosis, Relapsing-RemittingCondition: Multiple Sclerosis, Relapsing-Remitting


































datadata• 60.60.RecruitingRecruiting

Fish Oil for the Treatment of Depression in Patients With Multiple SclerosisFish Oil for the Treatment of Depression in Patients With Multiple SclerosisConditions: Multiple Sclerosis; DepressionConditions: Multiple Sclerosis; Depression

• 62.62.RecruitingRecruitingStudy of Study of TeriflunomideTeriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in P in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosisatients With Multiple Sclerosis

Condition: Multiple SclerosisCondition: Multiple Sclerosis• 65.65.RecruitingRecruitingEARLY IFNb-1a and EARLY IFNb-1a and AtorvastatinAtorvastatin

Combination Therapy of Isolated Clinical Syndrome Suggestive of Multiple Combination Therapy of Isolated Clinical Syndrome Suggestive of Multiple SclerosisSclerosis

Condition: Multiple SclerosisCondition: Multiple Sclerosis• 66.66.RecruitingRecruitingPilot Study of Pilot Study of TeriflunomideTeriflunomide

as Adjunctive Therapy to Interferon-β in Subjects With Multiple Sclerosis as Adjunctive Therapy to Interferon-β in Subjects With Multiple SclerosisCondition: Multiple SclerosisCondition: Multiple Sclerosis

• 67.67.RecruitingRecruitingPilot Study of Pilot Study of TeriflunomideTeriflunomide as Adjunctive Therapy to as Adjunctive Therapy to GlatiramerGlatiramer Acetate in Subjects With Multiple Sclerosis Acetate in Subjects With Multiple SclerosisCondition: Multiple SclerosisCondition: Multiple Sclerosis

• 70.70.RecruitingRecruitingStem Cell Therapy for Patients With Multiple Sclerosis Failing Interferon A RStem Cell Therapy for Patients With Multiple Sclerosis Failing Interferon A Randomized Studyandomized Study

Condition: Multiple SclerosisCondition: Multiple Sclerosis• 71.71.RecruitingRecruitingHigh-Dose High-Dose ImmunosuppressionImmunosuppression and and AutologousAutologous

Transplantation for Multiple Sclerosis (HALT MS) Study Transplantation for Multiple Sclerosis (HALT MS) StudyCondition: Multiple SclerosisCondition: Multiple Sclerosis

• 72.72.RecruitingRecruitingT-Cell Vaccination in Multiple Sclerosis (MS)T-Cell Vaccination in Multiple Sclerosis (MS)Condition: Multiple SclerosisCondition: Multiple Sclerosis



























datadata• 77.77.Not yet recruitingNot yet recruitingAA

Study in Multiple Sclerosis Patients to Determine the Safety of Different Do Study in Multiple Sclerosis Patients to Determine the Safety of Different Doses of A4I Compared to Placebo and Their Effects on Multiple Sclerosis Lesises of A4I Compared to Placebo and Their Effects on Multiple Sclerosis Lesionsons


Placebo Controlled Study in Subjects With Relapsing Forms of MS to EvaluaPlacebo Controlled Study in Subjects With Relapsing Forms of MS to Evaluate the Safety, Tolerability and Effects of CDP323te the Safety, Tolerability and Effects of CDP323

Condition: Multiple SclerosisCondition: Multiple Sclerosis• 86.86.RecruitingRecruitingMinocycline as Add-on to Interferon-Beta-1a (Minocycline as Add-on to Interferon-Beta-1a (RebifRebif

®) in RRMS (®) in RRMS (RecyclineRecycline))Condition: Relapsing-Remitting Multiple Sclerosis94.Condition: Relapsing-Remitting Multiple Sclerosis94.Not yet recruitingNot yet recruitingTheThe Effect of Effect of LevetiracetamLevetiracetam ( (KeppraKeppra) on the Treatment of Tremor in Multiple Sclerosis) on the Treatment of Tremor in Multiple SclerosisCondition: Multiple SclerosisCondition: Multiple Sclerosis

• 97.97.RecruitingRecruitingA Randomized Placebo-Controlled, Crossover-Design Study of the Effects ofA Randomized Placebo-Controlled, Crossover-Design Study of the Effects of Low Dose Low Dose NaltrexoneNaltrexoneCondition: Multiple SclerosisCondition: Multiple Sclerosis

• 98.98.RecruitingRecruitingPhase II Phase II CladribineCladribine Add-on to Add-on to RebifRebif New Formulation in MS Subjects With Active Disease (ONWARD) New Formulation in MS Subjects With Active Disease (ONWARD)Condition: Multiple SclerosisCondition: Multiple Sclerosis

• 99.99.RecruitingRecruitingFatigue Treatment Using Fatigue Treatment Using ProvigilProvigilCondition: All Multiple SclerosisPatientsCondition: All Multiple SclerosisPatients

• 100.100.RecruitingRecruitingNeuroprotection With Neuroprotection With RiluzoleRiluzole Patients With Early Multiple Sclerosis Patients With Early Multiple SclerosisCondition: Multiple SclerosisCondition: Multiple Sclerosis
































datadata

• 119.119.RecruitingRecruitingEffect of Effect of RiluzoleRiluzole as a Symptomatic Approach in Patients With Chronic as a Symptomatic Approach in Patients With Chronic CerebellarCerebellar Ataxia AtaxiaConditions: Hereditary Ataxia; Multiple Sclerosis; Cerebellar AtaxiaConditions: Hereditary Ataxia; Multiple Sclerosis; Cerebellar Ataxia

• 120.120.Not yet recruitingNot yet recruitingEvaluationEvaluation of of NatalizumabNatalizumab for for thEthE Relief of MS Associated Relief of MS Associated FatiGueFatiGueCondition: Multiple SclerosisCondition: Multiple Sclerosis

• 127.127.RecruitingRecruitingSafety and Tolerability of Safety and Tolerability of RituximabRituximab in in NeuromyelitisNeuromyelitis OpticaOpticaCondition: Neuromyelitis OpticaCondition: Neuromyelitis Optica

• 133.133.Not yet recruitingNot yet recruitingOligodendrocyteOligodendrocyte Progenitor Cell Culture From Human Brain Progenitor Cell Culture From Human BrainCondition: Demyelinating DiseasesCondition: Demyelinating Diseases

Studii clinice in desfasurare in Romania:Studii clinice in desfasurare in Romania:• 37.37.RecruitingRecruiting

Efficacy and Safety of BG00012 in Relapsing-Remitting Multiple SclerosisEfficacy and Safety of BG00012 in Relapsing-Remitting Multiple SclerosisCondition: Relapsing-Remitting Multiple SclerosisCondition: Relapsing-Remitting Multiple Sclerosis

• 40.Recruiting40.RecruitingEfficacy and Safety Study of BG00012 With Active Reference in Relapsing-REfficacy and Safety Study of BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosisemitting Multiple Sclerosis

Condition: Relapsing-Remitting Multiple SclerosisCondition: Relapsing-Remitting Multiple Sclerosis• 59.59.recruitingrecruitingSafety and Efficacy of Orally Administered Safety and Efficacy of Orally Administered LaquinimodLaquinimod

for Treatment of Relapsing Remitting Multiple Sclerosis (RRMS) for Treatment of Relapsing Remitting Multiple Sclerosis (RRMS)Condition: Multiple SclerosisCondition: Multiple Sclerosis



























Studii clinice in desfasurare in Romania - Studii clinice in desfasurare in Romania - detaliidetalii

Safety and Efficacy of Orally Administered Laquinimod for Treatment of Relapsing Safety and Efficacy of Orally Administered Laquinimod for Treatment of Relapsing Remitting Multiple Sclerosis (RRMSRemitting Multiple Sclerosis (RRMS

• Purpose Purpose Determination the efficacy of daily oral treatment with laquinimod 0.6 mg capsules as Determination the efficacy of daily oral treatment with laquinimod 0.6 mg capsules as compared to placebo in subjects with Relapsing Remitting Multiple Sclerosis (RRMS). compared to placebo in subjects with Relapsing Remitting Multiple Sclerosis (RRMS).

• Condition InterventionPhaseCondition InterventionPhaseMultiple Sclerosis Drug: LaquinimodMultiple Sclerosis Drug: Laquinimod Drug: Placebo Drug: PlaceboPhasePhase IIIIIIPrimary Outcome Measures: Primary Outcome Measures:

• Relapse Rate: Number of confirmed relapses during the double blind study period. [Time Frame: 24 Relapse Rate: Number of confirmed relapses during the double blind study period. [Time Frame: 24 months] months]

•Secondary Outcome Measures: Secondary Outcome Measures:

• Accumulation of physical disability measured by the time to confirmed progression of EDSS during Accumulation of physical disability measured by the time to confirmed progression of EDSS during the study period. [Time Frame: 24 months] the study period. [Time Frame: 24 months]

• MRI Outcomes [Time Frame: 12, 24 months] MRI Outcomes [Time Frame: 12, 24 months] •

Total Enrollment: 1000 Total Enrollment: 1000 • Study start: September 2007Study start: September 2007• ArmsAssigned InterventionsArmsAssigned Interventions1: Experimental Drug: Laquinimod Laquinimod 0.6 mg capsule, oral, 1: Experimental Drug: Laquinimod Laquinimod 0.6 mg capsule, oral,

once daily 2: Placebo Comparator Drug: Placebo Multinational, multicenter, randomized, double-once daily 2: Placebo Comparator Drug: Placebo Multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of daily oral administration of laquinimod 0.6mg in RRMS subjects. Eligible subjects will be equally daily oral administration of laquinimod 0.6mg in RRMS subjects. Eligible subjects will be equally randomized into one of the following treatment and placebo study groups. Subjects will be regularly randomized into one of the following treatment and placebo study groups. Subjects will be regularly evaluated at study sites including physical and neurological medical evaluation, clinical laboratory evaluated at study sites including physical and neurological medical evaluation, clinical laboratory testing and medical imaging evaluation. testing and medical imaging evaluation.

• Eligibility Eligibility • Ages Eligible for Study: 18 Years - 55 Years, Genders Eligible for Study: Both Ages Eligible for Study: 18 Years - 55 Years, Genders Eligible for Study: Both • CriteriaCriteria• Inclusion Criteria:Inclusion Criteria:• Between 18 and 55 years of age Between 18 and 55 years of age • Confirmed MS diagnosis with a relapsing-remitting disease course as defined by the Revised Confirmed MS diagnosis with a relapsing-remitting disease course as defined by the Revised

McDonald criteria McDonald criteria • Ambulatory with converted Kurtzke EDSS score of 0-5.5. Ambulatory with converted Kurtzke EDSS score of 0-5.5. • Exclusion Criteria:Exclusion Criteria:• MS diagnosis including progressive forms of MS MS diagnosis including progressive forms of MS • Women who are pregnant or breastfeeding Women who are pregnant or breastfeeding

http://clinicaltrials.gov/ct/info/phase



Studii clinice in desfasurare in Romania - Studii clinice in desfasurare in Romania - detaliidetalii

Efficacy and Safety of BG00012 in Relapsing-Remitting Multiple Sclerosis Efficacy and Safety of BG00012 in Relapsing-Remitting Multiple Sclerosis

Purpose : Purpose : To determine if treatment with BG00012 can decrease the number of MS relapses during a To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. To determine if, over time, BG00012 treatment can decrease the number of certain time period. To determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for the certain types of brain lesions commonly seen in MS patients and slow down the time it takes for the disease to get worse. disease to get worse.

• The purpose of this study is also to determine the safety of BG00012 and how well it is tolerated. The purpose of this study is also to determine the safety of BG00012 and how well it is tolerated. Another goal is to see what effect BG00012 may have on tests and evaluations used to assess MS. Another goal is to see what effect BG00012 may have on tests and evaluations used to assess MS.

• Primary Outcome Measures: Primary Outcome Measures: • To determine if BG00012 is effective in reducing the proportion of relapsing subjects at 2 years. To determine if BG00012 is effective in reducing the proportion of relapsing subjects at 2 years. •

Secondary Outcome Measures: Secondary Outcome Measures: • There are multiple secondary outcomes. There are multiple secondary outcomes. •

Total Enrollment: 1011 Total Enrollment: 1011 • Study start: January 2007Study start: January 2007• Eligibility Eligibility • Ages Eligible for Study: 18 Years - 55 Years, Genders Eligible for Study: Both Ages Eligible for Study: 18 Years - 55 Years, Genders Eligible for Study: Both

• Inclusion Criteria:Inclusion Criteria:• Unless otherwise specified, to be eligible to participate in this study, candidates must meet the Unless otherwise specified, to be eligible to participate in this study, candidates must meet the

following eligibility criteria at the time of the randomization: following eligibility criteria at the time of the randomization: • Aged 18 to 55 years old, inclusive, at the time of informed consent. Aged 18 to 55 years old, inclusive, at the time of informed consent. • Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4. Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4. • Must have a baseline EDSS between 0.0 and 5.0, inclusive. Must have a baseline EDSS between 0.0 and 5.0, inclusive. • Must have relapsing-remitting disease course. Must have relapsing-remitting disease course. • Exclusion CriteriaExclusion Criteria::• Unless otherwise specified, candidates will be excluded from study entry if any of the following Unless otherwise specified, candidates will be excluded from study entry if any of the following

exclusion criteria exist at randomization: exclusion criteria exist at randomization: • Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, Other chronic disease of the immune system, malignancies, acute urologic, pulmonary,

gastrointestinal disease. gastrointestinal disease. • Pregnant or nursing women. Pregnant or nursing women.

Noi posibilitati terapeutice in Noi posibilitati terapeutice in SM:SM:

- Terapia cu celule stem- Terapia cu celule stem- Vaccinuri- Vaccinuri

• premise etio-patogenice premise etio-patogenice

• principiile metodelor principiile metodelor

• stadiul rezultatelor actuale stadiul rezultatelor actuale

• studii clinice in desfasurare (detalii)studii clinice in desfasurare (detalii)

Noi posibilitati terapeutice in SM:Noi posibilitati terapeutice in SM:Terapia cu celule stemTerapia cu celule stemstudii clinice in desfasurare (detalii)studii clinice in desfasurare (detalii)

Mesenchymal Stem Cells in Multiple Sclerosis (MSCIMS)Mesenchymal Stem Cells in Multiple Sclerosis (MSCIMS)

• Sponsors and Collaborators:University of CambridgeSponsors and Collaborators:University of Cambridge Cambridge University Hospitals NHS Cambridge University Hospitals NHS Foundation Trust.Medical Research Council Foundation Trust.Medical Research Council

• Purpose Purpose Hypothesis: Intravenous administration of bone marrow-derived autologous adult human Hypothesis: Intravenous administration of bone marrow-derived autologous adult human mesenchymal stem cells is a safe novel therapeutic approach for patients with multiple sclerosis mesenchymal stem cells is a safe novel therapeutic approach for patients with multiple sclerosis

• Mesenchymal Stem Cells in Multiple Sclerosis (MSCIMS) is a phase I/IIA trial designed to establish Mesenchymal Stem Cells in Multiple Sclerosis (MSCIMS) is a phase I/IIA trial designed to establish the safety of intravenous administration of bone marrow-derived autologous adult human the safety of intravenous administration of bone marrow-derived autologous adult human mesenchymal stem cells to patients with multiple sclerosis. mesenchymal stem cells to patients with multiple sclerosis.

• Study Type: InterventionalStudy Type: InterventionalStudy Design: Treatment, Non-Randomized, Open Label, Historical Control, Crossover Assignment, Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Crossover Assignment, Safety/Efficacy Study Safety/Efficacy Study

• Official Title: Autologous Adult Human Mesenchymal Stem Cells: a Neuroprotective Therapy for Official Title: Autologous Adult Human Mesenchymal Stem Cells: a Neuroprotective Therapy for Multiple SclerosisMultiple Sclerosis

• Further study details as provided by University of Cambridge:Further study details as provided by University of Cambridge:

• Primary Outcome Measures: Primary Outcome Measures: • Adverse events Adverse events

Secondary Outcome Measures: Secondary Outcome Measures: • Visual function (acuity and colour) Visual function (acuity and colour) • Visual evoked potential latency Visual evoked potential latency • Optic nerve Magnetisation Transfer Ratio Optic nerve Magnetisation Transfer Ratio • Retinal nerve fibre layer thickness (by optical coherence tomography) Retinal nerve fibre layer thickness (by optical coherence tomography) • Brain lesion Magnetisation Transfer Ratio Brain lesion Magnetisation Transfer Ratio • MRI brain T1 hypointensity load MRI brain T1 hypointensity load • T cell response suppression T cell response suppression • Multiple Sclerosis Functional Composite Score Multiple Sclerosis Functional Composite Score • Expanded Kurtzke Disability Status Score Expanded Kurtzke Disability Status Score


• Total Enrollment: 20 Total Enrollment: 20 • Disease under investigation: Multiple SclerosisDisease under investigation: Multiple Sclerosis• Phase: I/IIAPhase: I/IIA• Number of patients: 20Number of patients: 20• Design: 1 year cross over, single treatment at 6 Design: 1 year cross over, single treatment at 6

monthsmonths• Intervention: Administration of bone marrow-Intervention: Administration of bone marrow-

derived autologous mesenchymal stem cellsderived autologous mesenchymal stem cells• Route of administration: IntravenousRoute of administration: Intravenous• Dose: 2,000,000 Mesenchymal Stem Cells per Dose: 2,000,000 Mesenchymal Stem Cells per

kilogramkilogram• Source of patients: Referrals accepted from Source of patients: Referrals accepted from

Neurologists in East Anglia and North London, Neurologists in East Anglia and North London, UKUK

• Referral Criteria: (all 4 required)Referral Criteria: (all 4 required)• Clinically definite multiple sclerosis Clinically definite multiple sclerosis • Disease duration 2 - 15 years Disease duration 2 - 15 years • Expanded Kurtzke Disability Status Score 2.0 - Expanded Kurtzke Disability Status Score 2.0 -

5.5 (inclusive) 5.5 (inclusive) • Evidence of optic nerve damage byEvidence of optic nerve damage by

– history of optic neuritis, or history of optic neuritis, or – relative afferent pupillary defect, or relative afferent pupillary defect, or – optic atrophy on fundoscopy, or optic atrophy on fundoscopy, or – abnormal visual evoked potential from abnormal visual evoked potential from

either or both eyes suggestive of either or both eyes suggestive of demyelinationdemyelination

Eligibility Eligibility Ages Eligible for Study: 18 Years Ages Eligible for Study: 18 Years - 50 Years, Genders Eligible for Study: - 50 Years, Genders Eligible for Study: Both Both

• Inclusion Criteria:Inclusion Criteria:• Clinically definite multiple sclerosis Clinically definite multiple sclerosis • Disease duration 2 - 15 years Disease duration 2 - 15 years • Expanded Kurtzke Disability Status Score 2.0 - Expanded Kurtzke Disability Status Score 2.0 -

5.5 5.5 • Evidence of optic nerve damage by: Evidence of optic nerve damage by: • history of optic neuritis, or history of optic neuritis, or • relative afferent pupillary defect, or relative afferent pupillary defect, or • optic atrophy on fundoscopy, or optic atrophy on fundoscopy, or • abnormal visual evoked potential from either abnormal visual evoked potential from either

or both eyes suggestive of demyelination or both eyes suggestive of demyelination • Prolonged visual evoked potential P100 latency Prolonged visual evoked potential P100 latency

with preserved waveform with preserved waveform • T2 lesion on MRI optic nerve T2 lesion on MRI optic nerve • <40% loss of retinal nerve fibre layer thickness <40% loss of retinal nerve fibre layer thickness

on optical coherence tomography on optical coherence tomography • Exclusion Criteria:Exclusion Criteria:• Age < 18 years Age < 18 years • Age > 50 years Age > 50 years • Patient lacks capacity to give informed consent Patient lacks capacity to give informed consent • Presence of a severe bleeding disorder Presence of a severe bleeding disorder • Planning a pregnancy during the trial period Planning a pregnancy during the trial period • Current MS disease modifying therapy Current MS disease modifying therapy • Location and Contact Information Location and Contact Information • Please refer to this study by ClinicalTrials.gov Please refer to this study by ClinicalTrials.gov

identifier NCT00395200 identifier NCT00395200 • Siddharthan Chandran, MBChB, PhD +44 Siddharthan Chandran, MBChB, PhD +44

(0) 1223 331160 (0) 1223 331160 [email protected]@cam.ac.uk

mailto:[email protected]?subject=NCT00395200,%20MRCRG44871:%20-%20%20Mesenchymal%20Stem%20Cells%20in%20Multiple%20Sclerosis%20(MSCIMS)


Donor Stem Cell Transplantation Donor Stem Cell Transplantation for the Treatment of Multiple for the Treatment of Multiple SclerosisSclerosis

• Purpose Purpose • While the cause of MS in not known, there is an While the cause of MS in not known, there is an

autoimmune component that destroys nerve cells. autoimmune component that destroys nerve cells. Autoimmunity is a condition where an individual's Autoimmunity is a condition where an individual's immune system attacks his/her own cells. Bone immune system attacks his/her own cells. Bone marrow stem cell transplantation has been shown marrow stem cell transplantation has been shown to halt autoimmunity. Stem cell transplant can be to halt autoimmunity. Stem cell transplant can be performed using the patient’s own cells, or donor performed using the patient’s own cells, or donor cells. The general consensus in the field is that cells. The general consensus in the field is that donor transplant is most likely to halt disease donor transplant is most likely to halt disease progression. This study is designed to evaluate the progression. This study is designed to evaluate the safety of a donor transplant procedure as a therapy safety of a donor transplant procedure as a therapy for relapsing remitting multiple sclerosis (RRMS). for relapsing remitting multiple sclerosis (RRMS).

• Two factors limit the widespread application of Two factors limit the widespread application of traditional donor stem cell transplant: 1) preparing traditional donor stem cell transplant: 1) preparing the patient for transplant (conditioning); and 2) the patient for transplant (conditioning); and 2) graft-versus-host disease (GVHD). Traditional graft-versus-host disease (GVHD). Traditional conditioning destroys the recipient's immune conditioning destroys the recipient's immune system and requires that the marrow transplant be system and requires that the marrow transplant be successful because the patient is unable to fight off successful because the patient is unable to fight off infection if the donor cells do not survive. GVHD infection if the donor cells do not survive. GVHD occurs when donor immune cells recognize the occurs when donor immune cells recognize the recipient’s cells as foreign tissue and attack them. recipient’s cells as foreign tissue and attack them. Severe GVHD can result in death. Severe GVHD can result in death.

• This study utilizes a new approach to conditioning This study utilizes a new approach to conditioning which leaves the patient's immune system intact. which leaves the patient's immune system intact. The transplant product is depleted of GVHD-The transplant product is depleted of GVHD-producing cells but retains tolerance-promoting producing cells but retains tolerance-promoting cells, called facilitating cells, which are intended to cells, called facilitating cells, which are intended to ensure the donor and recipient cells coexists ensure the donor and recipient cells coexists peacefully. The toxicity of conditioning and peacefully. The toxicity of conditioning and transplantation is significantly reduced. The end transplantation is significantly reduced. The end result is a marrow system that contains recipient result is a marrow system that contains recipient and donor cells, a state called mixed chimerism. and donor cells, a state called mixed chimerism.

• In this study, we will determine the In this study, we will determine the appropriate cell dose to safely establish appropriate cell dose to safely establish mixed chimerism following partial mixed chimerism following partial conditioning in patients with RRMS. The study conditioning in patients with RRMS. The study takes a gradual approach to increasing the takes a gradual approach to increasing the cell dose to achieve mixed chimerism. Each cell dose to achieve mixed chimerism. Each patient will receive a cell dose one unit above patient will receive a cell dose one unit above the dose received by the most recent safely the dose received by the most recent safely transplanted patient. We believe this study transplanted patient. We believe this study will provide a breakthrough in the treatment will provide a breakthrough in the treatment of MS. The goal of this proposal is to evaluate of MS. The goal of this proposal is to evaluate the potential of safely establishing mixed the potential of safely establishing mixed chimerism to interrupt the autoimmune chimerism to interrupt the autoimmune process and end the devastating effects of process and end the devastating effects of MS. MS.

• Primary Outcome Measures: Primary Outcome Measures: • Stem cell engraftment/chimerism Stem cell engraftment/chimerism •

Secondary Outcome Measures: Secondary Outcome Measures: • Disease remission Disease remission •

Total Enrollment: 15 Total Enrollment: 15

Noi posibilitati terapeutice in SM:Noi posibilitati terapeutice in SM:Terapia cu celule stemTerapia cu celule stemstudii clinice in desfasurare (detalii)studii clinice in desfasurare (detalii)• Eligibility Eligibility • Ages Eligible for Study: 18 Years - 55 Years, Ages Eligible for Study: 18 Years - 55 Years,

Genders Eligible for Study: Both Genders Eligible for Study: Both • Inclusion Criteria: Inclusion Criteria: • Clinically definite MS according to the Clinically definite MS according to the

McDonald criteria McDonald criteria • Confirmed diagnosis of relapsing-remitting MS. Confirmed diagnosis of relapsing-remitting MS. • Age between 18 and 55 years Age between 18 and 55 years • Extended Disability Status Score (EDSS) Extended Disability Status Score (EDSS)

between 0 and 5.0 between 0 and 5.0 • Relapse within the last year or sustained Relapse within the last year or sustained

disability progression of 1.0 for six months disability progression of 1.0 for six months • Treatment with high dose, high frequency Treatment with high dose, high frequency

Interferon-β therapy, or failure to tolerate Interferon-β therapy, or failure to tolerate Interferon-β therapy Interferon-β therapy

• DLCO> 50% (unless cleared by physician) DLCO> 50% (unless cleared by physician) • EF > 40% (unless cleared by cardiologist) EF > 40% (unless cleared by cardiologist) • Required initial laboratory data (obtained Required initial laboratory data (obtained

within 30 days prior to transplant, unless within 30 days prior to transplant, unless otherwise specified)otherwise specified)

– HIV-1,2 antigen and antibody negative HIV-1,2 antigen and antibody negative – HBsAg negative (chronic hepatitis B HBsAg negative (chronic hepatitis B

carriers without clinical evidence of liver carriers without clinical evidence of liver disease can be considered on an disease can be considered on an individual basis if it is determined that the individual basis if it is determined that the added risk is justified by the prognosis added risk is justified by the prognosis and lack of treatment alternatives) and lack of treatment alternatives)

– Hepatitis C antibody negative (positive Hepatitis C antibody negative (positive antibody allowed if antigen (RNA)-antibody allowed if antigen (RNA)-negative and no clinical evidence of negative and no clinical evidence of cirrhosis) cirrhosis)

– CMV, hepatitis B, HTLV-1,2, EBV, and CMV, hepatitis B, HTLV-1,2, EBV, and Herpes antibody status known Herpes antibody status known

– Pregnancy test negativePregnancy test negative

• No life-threatening organ dysfunction.No life-threatening organ dysfunction.– Uncontrolled or severe cardiovascular Uncontrolled or severe cardiovascular

disease, including recent (<6 months) disease, including recent (<6 months) myocardial infarction, angina myocardial infarction, angina (symptomatic despite optimal medical (symptomatic despite optimal medical management), life-threatening management), life-threatening arrhythmia or hypertension arrhythmia or hypertension

• Able to give informed consent Able to give informed consent • Exclusion Criteria:Exclusion Criteria:• Women who are of child bearing potential Women who are of child bearing potential

must have a negative pregnancy test (serum must have a negative pregnancy test (serum pregnancy test [HCG]) within 48 hours of pregnancy test [HCG]) within 48 hours of initiating total body irradiation and agree to initiating total body irradiation and agree to use reliable contraception for 1 year following use reliable contraception for 1 year following transplant. transplant.

• Concomitant severe diseases (respiratory, Concomitant severe diseases (respiratory, renal, liver, cardiac failures, psychiatric renal, liver, cardiac failures, psychiatric disorders, neoplasms) disorders, neoplasms)

• Recurrent urinary, pulmonary infections. Recurrent urinary, pulmonary infections. • Active bacterial, viral, or fungal infection Active bacterial, viral, or fungal infection • Active peptic ulcer disease Active peptic ulcer disease • Previous treatments with total lymphoid Previous treatments with total lymphoid

irradiation or total body irradiation irradiation or total body irradiation • Interferon-neutralizing antibody positive with Interferon-neutralizing antibody positive with

a titer greater than 20 a titer greater than 20 • Relapse in the month preceding enrollment Relapse in the month preceding enrollment • Poor compliance Poor compliance • Location and Contact Information Location and Contact Information

United States, KentuckyUnited States, Kentucky Institute for Cellular Therapeutics, Institute for Cellular Therapeutics, University of Louisville, Louisville, Kentucky, University of Louisville, Louisville, Kentucky, 40202, United States; 40202, United States;

Noi posibilitati terapeutice in SM:Noi posibilitati terapeutice in SM:Terapia cu celule stemTerapia cu celule stemstudii clinice in desfasurare (detalii)studii clinice in desfasurare (detalii)• Stem Cell Therapy for Patients Stem Cell Therapy for Patients

With Multiple Sclerosis Failing With Multiple Sclerosis Failing Interferon A Randomized Interferon A Randomized StudyStudy

• Total Enrollment: 110 Total Enrollment: 110 • Study start: January 2006Study start: January 2006• To assess the efficacy of autologous PBSCT versus FDA To assess the efficacy of autologous PBSCT versus FDA

approved standard of care ( i.e. interferon, copaxone, approved standard of care ( i.e. interferon, copaxone, or mitoxantrone) for inflammatory multiple sclerosis or mitoxantrone) for inflammatory multiple sclerosis failing interferon therapy. The endpoints to be failing interferon therapy. The endpoints to be considered in this study are: considered in this study are:

• Eligibility Eligibility • Ages Eligible for Study: 18 Years - 55 Years, Ages Eligible for Study: 18 Years - 55 Years,

Genders Eligible for Study: Both Genders Eligible for Study: Both • CriteriaCriteria• Inclusion Criteria:Inclusion Criteria:• Age between 18-55, inclusive. Age between 18-55, inclusive. • Diagnosis of MS using Poser criteria of “clinically Diagnosis of MS using Poser criteria of “clinically

definite” MS (Appendix A). definite” MS (Appendix A). • An EDSS of 2.0 to 6.0 (Appendix B). An EDSS of 2.0 to 6.0 (Appendix B). • Inflammatory disease despite primary disease Inflammatory disease despite primary disease

modifying therapy with at least 4 months of interferon. modifying therapy with at least 4 months of interferon. Inflammatory disease is defined by either MRI showing Inflammatory disease is defined by either MRI showing gadolinium enhancing lesions or clinically as acute gadolinium enhancing lesions or clinically as acute relapses treated with IV solumedrol. Failure is defined relapses treated with IV solumedrol. Failure is defined as two or more clinical relapses with documented as two or more clinical relapses with documented neurologic changes within the year prior to the study. neurologic changes within the year prior to the study. (NOTE: Relapses must have required treatment with (NOTE: Relapses must have required treatment with corticosteroids). Failure may also be defined as one corticosteroids). Failure may also be defined as one relapse within the year prior to study if there is relapse within the year prior to study if there is evidence on MRI of active inflammation (i.e., evidence on MRI of active inflammation (i.e., gadolinium enhancement). gadolinium enhancement).

• Exclusion criteriaExclusion criteria

• Inability or unwillingness to pursue effective means of Inability or unwillingness to pursue effective means of birth control. Effective birth control is defined as 1) birth control. Effective birth control is defined as 1) refraining from all acts of vaginal intercourse refraining from all acts of vaginal intercourse (ABSTINENCE); 2) consistent use of birth control pills; (ABSTINENCE); 2) consistent use of birth control pills; 3) injectable birth control methods (Depo-provera, 3) injectable birth control methods (Depo-provera, Norplant); 4) tubal sterilization or male partner who Norplant); 4) tubal sterilization or male partner who has undergone vasectomy; 5) placement of an IUD has undergone vasectomy; 5) placement of an IUD (intrauterine device); or 6) use, with every act of (intrauterine device); or 6) use, with every act of intercourse, of diaphragm with contraceptive jelly intercourse, of diaphragm with contraceptive jelly and/or condoms with contraceptive foam. and/or condoms with contraceptive foam.

• Failure to willingly accept or comprehend irreversible Failure to willingly accept or comprehend irreversible sterility as a side effect of therapy. sterility as a side effect of therapy.

• FEV1/FVC < 60% of predicted after bronchodilator FEV1/FVC < 60% of predicted after bronchodilator therapy (if necessary). therapy (if necessary).

• DLCO < 50% of predicted. DLCO < 50% of predicted. • Resting LVEF < 50 %. Resting LVEF < 50 %. • Bilirubin > 2.0 mg/dl. Bilirubin > 2.0 mg/dl. • Serum creatinine > 2.0 mg/dl. Serum creatinine > 2.0 mg/dl. • Known hypersensitivity to mouse, rabbit, or E. Coli Known hypersensitivity to mouse, rabbit, or E. Coli

derived proteins, or to iron compounds/medications. derived proteins, or to iron compounds/medications. • Presence of metallic objects implanted in the body Presence of metallic objects implanted in the body

that would preclude the ability of the patient to safely that would preclude the ability of the patient to safely have MRI exams. have MRI exams.

• Diagnosis of primary progressive MS. Diagnosis of primary progressive MS. • Platelet count < 100,000/ul, WBC < 1,500 cells/mm3. Platelet count < 100,000/ul, WBC < 1,500 cells/mm3. • Psychiatric illness, mental deficiency or cognitive Psychiatric illness, mental deficiency or cognitive

dysfunction making compliance with treatment or dysfunction making compliance with treatment or informed consent impossible. informed consent impossible.

• Active infection except asymptomatic bacteruria. Active infection except asymptomatic bacteruria. • Location and Contact Information Location and Contact Information • Please refer to this study by ClinicalTrials.gov Please refer to this study by ClinicalTrials.gov

identifier NCT00273364 identifier NCT00273364 •

United States, IllinoisUnited States, Illinois Northwestern University, Feinberg School of Northwestern University, Feinberg School of Medicine, Chicago, Illinois, 60611, United Medicine, Chicago, Illinois, 60611, United States; Recruiting States; Recruiting

• Dzemila Spahovic, MD 312-908-0059 Dzemila Spahovic, MD 312-908-0059 [email protected]@northwestern.edu Richard Burt, MD, Principal InvestigatorRichard Burt, MD, Principal Investigator

mailto:[email protected]?subject=NCT00273364,%20DI%20MS.Randomized2004:%20-%20%20Stem%20Cell%20Therapy%20for%20Patients%20With%20Multiple%20Sclerosis%20Failing%20Interferon%20A%20Randomized%20Study

Noi posibilitati terapeutice in SM:Noi posibilitati terapeutice in SM:Terapia cu celule stemTerapia cu celule stemstudii clinice in desfasurare (detalii)studii clinice in desfasurare (detalii)High-Dose Immunosuppression and Autologous Transplantation for High-Dose Immunosuppression and Autologous Transplantation for Multiple Sclerosis (HALT MS) StudyMultiple Sclerosis (HALT MS) Study

• Purpose Purpose • The purpose of this study is to determine the effectiveness The purpose of this study is to determine the effectiveness

of a new treatment for multiple sclerosis (MS), a serious of a new treatment for multiple sclerosis (MS), a serious disease in which the immune system attacks the brain and disease in which the immune system attacks the brain and spinal cord. MS can be progressive and severe and lead to spinal cord. MS can be progressive and severe and lead to significant disability. The study treatment involves the use significant disability. The study treatment involves the use of high-dose chemotherapeutic drugs to suppress the of high-dose chemotherapeutic drugs to suppress the immune system. The participant’s own (autologous) blood-immune system. The participant’s own (autologous) blood-forming (hematopoietic, CD34+) stem cells are collected forming (hematopoietic, CD34+) stem cells are collected before the chemotherapy is given, and then transplanted before the chemotherapy is given, and then transplanted back into the body following treatment. Transplantation of back into the body following treatment. Transplantation of autologous hematopoietic stem cells is required to prevent autologous hematopoietic stem cells is required to prevent very prolonged periods of low blood cell counts after the very prolonged periods of low blood cell counts after the high-dose chemotherapy. high-dose chemotherapy.

• Phase IIPhase IITotal Enrollment: 30 Total Enrollment: 30

• Eligibility Eligibility Ages Eligible for Study: 18 Years - 60 Years, Ages Eligible for Study: 18 Years - 60 Years, Genders Eligible for Study: Both Genders Eligible for Study: Both

• Inclusion Criteria:Inclusion Criteria:• Diagnosis of relapsing-remitting or progressive-relapsing Diagnosis of relapsing-remitting or progressive-relapsing

multiple sclerosis for less than 10 years using McDonald multiple sclerosis for less than 10 years using McDonald Criteria. More information on this criterion can be found in Criteria. More information on this criterion can be found in the protocol. the protocol.

• Score between 3.0 and 5.5 on the Expanded Disability Score between 3.0 and 5.5 on the Expanded Disability Status Scale (EDSS) Status Scale (EDSS)

• T2 abnormalities on brain MRI consistent with MS T2 abnormalities on brain MRI consistent with MS • Two or more relapses in 12 months time on interferon Two or more relapses in 12 months time on interferon

(IFN), glatiramer acetate (GA), or mitoxantrone with EDSS (IFN), glatiramer acetate (GA), or mitoxantrone with EDSS increase greater than 0.5, maintained for greater than 3 increase greater than 0.5, maintained for greater than 3 months OR one relapse on IFN, GA, or mitoxantrone, months OR one relapse on IFN, GA, or mitoxantrone, together with MRI changes consistent with poor prognosis. together with MRI changes consistent with poor prognosis. On IFN or GA for at least 6 months before the relapses On IFN or GA for at least 6 months before the relapses occur that are counted to satisfy previous inclusion occur that are counted to satisfy previous inclusion criterion OR have received at least 3 doses of criterion OR have received at least 3 doses of mitoxantrone on a treatment schedule before the relapses mitoxantrone on a treatment schedule before the relapses occur that are counted to satisfy previous inclusion occur that are counted to satisfy previous inclusion criterion criterion

• Approval by an MS Review Panel to participate in the Approval by an MS Review Panel to participate in the study. More information on this criterion can be found in study. More information on this criterion can be found in the protocol. the protocol.

• In good clinical condition with adequate organ function and In good clinical condition with adequate organ function and without coexisting medical problems that would increase without coexisting medical problems that would increase the risk to the participant the risk to the participant

• Willing to use acceptable methods of contraception Willing to use acceptable methods of contraception • Willing and able to comply with all study requirements Willing and able to comply with all study requirements • Willing to accept and comprehend irreversible sterility as side effect Willing to accept and comprehend irreversible sterility as side effect

of therapy of therapy • Exclusion Criteria:Exclusion Criteria:• Primary progressive MS Primary progressive MS • Secondary progressive MS without relapses (i.e., progression without Secondary progressive MS without relapses (i.e., progression without

exacerbations or relapses) for 12 or more months exacerbations or relapses) for 12 or more months • Neuromyelitis optica, a disease similar to MS Neuromyelitis optica, a disease similar to MS • Initiation of new immunosuppressant treatment after the participant Initiation of new immunosuppressant treatment after the participant

becomes eligible for the protocol or continuance of becomes eligible for the protocol or continuance of immunosuppressant drugs after the participant is screened for the immunosuppressant drugs after the participant is screened for the protocol. Treatment with IFN, GA, or corticosteroids is permitted protocol. Treatment with IFN, GA, or corticosteroids is permitted after the participant becomes eligible for the protocol. after the participant becomes eligible for the protocol.

• Lapse of greater than 4 months between the time a participant is Lapse of greater than 4 months between the time a participant is eligible for the protocol and initiation of protocol treatment except eligible for the protocol and initiation of protocol treatment except when judged acceptable by the MS Review Panel when judged acceptable by the MS Review Panel

• Prior treatment with investigational immunosuppressive agents Prior treatment with investigational immunosuppressive agents within 3 months of study eligibility within 3 months of study eligibility

• Prior treatment with natalizumab Prior treatment with natalizumab • History of cytopenia consistent with the diagnosis of myelodysplastic History of cytopenia consistent with the diagnosis of myelodysplastic

syndrome (MDS) syndrome (MDS) • Active hepatitis B or C infection, cirrhosis, or HIV infection Active hepatitis B or C infection, cirrhosis, or HIV infection • Uncontrolled diabetes mellitus Uncontrolled diabetes mellitus • Uncontrolled viral, fungal, or bacterial infection. Patients with Uncontrolled viral, fungal, or bacterial infection. Patients with

asymptomatic bacteriuria are not excluded. asymptomatic bacteriuria are not excluded. • Any illness that would jeopardize the ability to tolerate aggressive Any illness that would jeopardize the ability to tolerate aggressive

chemotherapy chemotherapy • Prior history of malignancy, except localized basal cell or squamous Prior history of malignancy, except localized basal cell or squamous

skin cancer. Other malignancies for which the subject is judged skin cancer. Other malignancies for which the subject is judged cured by the administered therapy will be considered on an cured by the administered therapy will be considered on an individual basis. individual basis.

• Hypersensitivity to mouse, rabbit, or Escherichia coli-derived Hypersensitivity to mouse, rabbit, or Escherichia coli-derived proteins or to iron compounds/medications proteins or to iron compounds/medications

• Metallic objects implanted in the body that would affect MRI exams Metallic objects implanted in the body that would affect MRI exams • Psychiatric illness, mental deficiency, or cognitive dysfunction Psychiatric illness, mental deficiency, or cognitive dysfunction • Pregnancy Pregnancy



Oligodendrocyte Progenitor Cell Culture From Human Oligodendrocyte Progenitor Cell Culture From Human BrainBrain

• Purpose Purpose Recent developments in the understanding of stem- and progenitor cell Recent developments in the understanding of stem- and progenitor cell differentiation raises hopes that brain damage in chronic neurological diseases may differentiation raises hopes that brain damage in chronic neurological diseases may become repaired by systemic or focal transplantation of such cells. Clinical trials of become repaired by systemic or focal transplantation of such cells. Clinical trials of stem- or progenitor cell transplantation in multiple sclerosis are currently premature. stem- or progenitor cell transplantation in multiple sclerosis are currently premature. The researchers developed a protocol for human oligodendrocyte progenitor cell The researchers developed a protocol for human oligodendrocyte progenitor cell culture from human brain for the treatment of demyelinating disease. culture from human brain for the treatment of demyelinating disease.

• Phase IPhase I• Primary Outcome Measures: Primary Outcome Measures: • Number of oligodendrocyte progenitor cell differentiation Number of oligodendrocyte progenitor cell differentiation •

Total Enrollment: 100 Total Enrollment: 100 • Expected completion: March 2008Expected completion: March 2008• Eligibility Eligibility • Ages Eligible for Study: 20 Years - 65 Years, Genders Eligible for Study: Both Ages Eligible for Study: 20 Years - 65 Years, Genders Eligible for Study: Both • CriteriaCriteria• Inclusion Criteria:Inclusion Criteria:• Male or female 20-65 years of age Male or female 20-65 years of age • Informed consent Informed consent • Has elective craniotomy surgery Has elective craniotomy surgery • Exclusion Criteria:Exclusion Criteria:• HIV, hepatitis, and other central nervous system (CNS) infections HIV, hepatitis, and other central nervous system (CNS) infections • Dementia, Alzheimer disease, and neurodegenerative disease Dementia, Alzheimer disease, and neurodegenerative disease

Noi posibilitati terapeutice in SM:Noi posibilitati terapeutice in SM:VaccinuriVaccinuristudii clinice in desfasurare (detalii)studii clinice in desfasurare (detalii)

TCV -01-002: T-Cell Vaccination in the Treatment of Probable TCV -01-002: T-Cell Vaccination in the Treatment of Probable Multiple SclerosisMultiple Sclerosis

• Purpose Purpose • In the present study, we, the investigators at Sheba Medical Center, intend to evaluate T cell In the present study, we, the investigators at Sheba Medical Center, intend to evaluate T cell

vaccination (TCV) in patients with probable multiple sclerosis (MS) within up to 3 months after the first vaccination (TCV) in patients with probable multiple sclerosis (MS) within up to 3 months after the first clinical attack. It is of the utmost importance to evaluate the treatment effects at the onset of disease, clinical attack. It is of the utmost importance to evaluate the treatment effects at the onset of disease, i.e. in patients with probable MS, in order to evaluate whether early treatment can prevent the second i.e. in patients with probable MS, in order to evaluate whether early treatment can prevent the second attack (conversion to definite MS). Moreover, at disease onset, the immunological process of epitope attack (conversion to definite MS). Moreover, at disease onset, the immunological process of epitope spreading associated with the exposure of the immune system to myelin antigens is still limited. With spreading associated with the exposure of the immune system to myelin antigens is still limited. With additional attacks, increased recognition of new self-determinants of encephalitogenic peptides additional attacks, increased recognition of new self-determinants of encephalitogenic peptides presented to the immune system during the inflammatory process occurs, and enhances further disease presented to the immune system during the inflammatory process occurs, and enhances further disease activity. The aim of the early TCV treatment approach is to stop this process as early as possible, during activity. The aim of the early TCV treatment approach is to stop this process as early as possible, during the onset of the disease, thus preventing additional attacks and disease progression. the onset of the disease, thus preventing additional attacks and disease progression.

• We will evaluate the effect of TCV on clinical, immunological and magnetic resonance imaging (MRI) We will evaluate the effect of TCV on clinical, immunological and magnetic resonance imaging (MRI) parameters in patients with probable MS. parameters in patients with probable MS.

• Phase III Study Type: InterventionalPhase III Study Type: InterventionalStudy Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study Efficacy Study

• Primary Outcome Measures: Primary Outcome Measures: • The rate of progression to definite MS (second attack) during the study The rate of progression to definite MS (second attack) during the study • Time to progression to definite MS (second attack) Time to progression to definite MS (second attack) •

Secondary Outcome Measures: Secondary Outcome Measures: • Change in the count of new gadolinium (GD) enhancing lesions from two baseline (B) MRIs to the final Change in the count of new gadolinium (GD) enhancing lesions from two baseline (B) MRIs to the final

(F) MRIs (F) MRIs • Change in total volume of new GD enhancing lesions from two baseline MRIs (B) to the final MRIs (F) Change in total volume of new GD enhancing lesions from two baseline MRIs (B) to the final MRIs (F) • The change in neurological disability as measured by the Expanded Disability Status Scale (EDSS) The change in neurological disability as measured by the Expanded Disability Status Scale (EDSS) •


• Total Enrollment: 80 Total Enrollment: 80 • Inclusion criteria:Inclusion criteria:• Age: 15 - 50 years. Age: 15 - 50 years. • Three months within the acute onset of neurological symptoms suggestive of the first attack of Three months within the acute onset of neurological symptoms suggestive of the first attack of

multiple sclerosis. multiple sclerosis. • Diagnosis of CPMS C3 (Poser criteria). Diagnosis of CPMS C3 (Poser criteria). • Positive brain MRI according to Fazekas criteria. Positive brain MRI according to Fazekas criteria. • Negative pregnancy test and use of effective contraceptive for female patients who are sexually Negative pregnancy test and use of effective contraceptive for female patients who are sexually

active. active. • Signed written informed consent. Signed written informed consent. • Exclusion criteria:Exclusion criteria:• Blood tests suggestive of other autoimmune diseases. Blood tests suggestive of other autoimmune diseases. • Known allergic reactions to MRI contrast media. Known allergic reactions to MRI contrast media. • A clear regression of the neurological symptoms after the first attack that suggests a primary-A clear regression of the neurological symptoms after the first attack that suggests a primary-

progressive course. progressive course. • Corticosteroid treatment in the previous 4 weeks (28 days). Corticosteroid treatment in the previous 4 weeks (28 days). • Previous treatment with immunosuppressive medications such as cyclophosphamide, Previous treatment with immunosuppressive medications such as cyclophosphamide,

azathioprine, methotrexate, mitoxantrone or cyclosporine. azathioprine, methotrexate, mitoxantrone or cyclosporine. • Previous treatment with interferon beta 1a or 1b, copolymer-1, IVIg, plasmapheresis. Previous treatment with interferon beta 1a or 1b, copolymer-1, IVIg, plasmapheresis.

• Location and Contact InformationLocation and Contact Information Sheba Medical Center, Ramat Gan, 52621, Israel; Sheba Medical Center, Ramat Gan, 52621, Israel;


T-Cell Vaccination in Multiple T-Cell Vaccination in Multiple Sclerosis (MS)Sclerosis (MS)

• Purpose Purpose • The purpose of this study is to The purpose of this study is to

evaluate the safety of T-cell evaluate the safety of T-cell vaccination in MS patients.vaccination in MS patients.

• Immunization of MS patients with Immunization of MS patients with irradiated autologous encephalitogenic irradiated autologous encephalitogenic myelin peptides (EMP) specific T-cell myelin peptides (EMP) specific T-cell lines or clones.lines or clones.

• Clinical immunologic and Clinical immunologic and neuroradiologic evaluation.neuroradiologic evaluation.

• Primary Outcome Measures: Primary Outcome Measures: • safety assessment of T-cell vaccination safety assessment of T-cell vaccination

in nonresponding MS patients in nonresponding MS patients • Phase IPhase I

Phase IIPhase IITotal Enrollment: 20 Total Enrollment: 20

• Eligibility Eligibility • Ages Eligible for Study: 16 Years - Ages Eligible for Study: 16 Years -

60 Years, Genders Eligible for Study: 60 Years, Genders Eligible for Study: Both Both

• CriteriaCriteria• Inclusion Criteria:Inclusion Criteria:• Definite MS (post criteria) Definite MS (post criteria) • Relapsing remitting or primary Relapsing remitting or primary

progressive clinical course. At least progressive clinical course. At least one relapse in the last two years. one relapse in the last two years.

• Disease duration > 1 year Disease duration > 1 year • Expanded Disability Status Scale Expanded Disability Status Scale

(EDSS) between 0-6 (EDSS) between 0-6 • Brain magnetic resonance imaging Brain magnetic resonance imaging

(MRI) compatible with MS (MRI) compatible with MS • Not involved in any other clinical trials Not involved in any other clinical trials • No other systemic disease No other systemic disease • Exclusion Criteria:Exclusion Criteria:• Does not comply with the above Does not comply with the above

• Location and Contact Information Location and Contact Information • Multiple Sclerosis Center, Ramat Multiple Sclerosis Center, Ramat

Gan, Israel;Gan, Israel;



Noi posibilitati terapeutice in SM: Noi posibilitati terapeutice in SM: VaccinuriVaccinuriInduction of Antigen-Specific Tolerance in Multiple Sclerosis After Induction of Antigen-Specific Tolerance in Multiple Sclerosis After Immunization With DNA Encoding Myelin Basic Protein in a Immunization With DNA Encoding Myelin Basic Protein in a Randomized, Placebo-Controlled Phase 1/2 TrialRandomized, Placebo-Controlled Phase 1/2 Trial

Amit Bar-Or, MD; Timothy Vollmer, MD; Jack Antel, MD; Douglas L. Arnold, MD; Caroline Amit Bar-Or, MD; Timothy Vollmer, MD; Jack Antel, MD; Douglas L. Arnold, MD; Caroline AnitaAnita Arch Neurol.Arch Neurol. 20072007; ;

Objective Objective To assess safety and immune modulation by BHT-3009, a tolerizing DNA To assess safety and immune modulation by BHT-3009, a tolerizing DNA vaccine encoding full-length human myelin basic protein, in patients with multiple sclerosis vaccine encoding full-length human myelin basic protein, in patients with multiple sclerosis (MS). (MS).

• Design Design The study was a randomized, double-blind, placebo-controlled trial. Subjects The study was a randomized, double-blind, placebo-controlled trial. Subjects receiving placebo were crossed over into an active arm after treatment unblinding. receiving placebo were crossed over into an active arm after treatment unblinding.

• Setting Setting The trial was conducted at 4 academic institutions within North America. The trial was conducted at 4 academic institutions within North America. • Patients Patients Thirty patients with relapsing-remitting or secondary progressive MS who were Thirty patients with relapsing-remitting or secondary progressive MS who were

not taking any other disease-modifying drugs were enrolled in the trial. Further, the patients not taking any other disease-modifying drugs were enrolled in the trial. Further, the patients were required to have either 1 to 5 gadolinium-enhancing lesions on screening brain were required to have either 1 to 5 gadolinium-enhancing lesions on screening brain magnetic resonance imaging (MRI), a relapse in the previous 2 years, or disease worsening magnetic resonance imaging (MRI), a relapse in the previous 2 years, or disease worsening in the previous 2 years. in the previous 2 years.

• Interventions Interventions BHT-3009 was administered as intramuscular injections at weeks 1, 3, 5, BHT-3009 was administered as intramuscular injections at weeks 1, 3, 5, and 9 after randomization into the trial, with or without 80 mg of daily oral atorvastatin and 9 after randomization into the trial, with or without 80 mg of daily oral atorvastatin calcium in combination. Three dose levels of BHT-3009 were tested (0.5 mg, 1.5 mg, and 3 calcium in combination. Three dose levels of BHT-3009 were tested (0.5 mg, 1.5 mg, and 3 mg). mg).

• Main Outcome Measures Main Outcome Measures The primary outcome measures were safety and tolerability of The primary outcome measures were safety and tolerability of BHT-3009. Secondary outcome measures included the number and volume of gadolinium-BHT-3009. Secondary outcome measures included the number and volume of gadolinium-enhanced lesions on MRI, relapses, and analysis of antigen-specific immune responses. enhanced lesions on MRI, relapses, and analysis of antigen-specific immune responses.

• Results Results BHT-3009 was safe and well tolerated, provided favorable trends on brain MRI, BHT-3009 was safe and well tolerated, provided favorable trends on brain MRI, and produced beneficial antigen-specific immune changes. These immune changes and produced beneficial antigen-specific immune changes. These immune changes consisted of a marked decrease in proliferation of interferon-–producing, myelin-reactive consisted of a marked decrease in proliferation of interferon-–producing, myelin-reactive CD4+ T cells from peripheral blood and a reduction in titers of myelin-specific CD4+ T cells from peripheral blood and a reduction in titers of myelin-specific autoantibodies from cerebral spinal fluid as assessed by protein microarrays. We did not autoantibodies from cerebral spinal fluid as assessed by protein microarrays. We did not observe a substantial benefit of the atorvastatin combination compared with BHT-3009 observe a substantial benefit of the atorvastatin combination compared with BHT-3009 alone. alone.

• Conclusion Conclusion In patients with MS, BHT-3009 is safe and induces antigen-specific immune In patients with MS, BHT-3009 is safe and induces antigen-specific immune tolerance with concordant reduction of inflammatory lesions on brain MRI. tolerance with concordant reduction of inflammatory lesions on brain MRI.

Noi posibilitati terapeutice in SM: Noi posibilitati terapeutice in SM: VaccinuriVaccinuri

Induction of Antigen-Specific Tolerance in Multiple Sclerosis After Induction of Antigen-Specific Tolerance in Multiple Sclerosis After Immunization With DNA Encoding Myelin Basic Protein in a Immunization With DNA Encoding Myelin Basic Protein in a Randomized, Placebo-Controlled Phase 1/2 TrialRandomized, Placebo-Controlled Phase 1/2 Trial

http://archneur.ama-assn.org/cgi/content/full/64.10.nct70002

CONCLUZIICONCLUZII

• Terapia SM este in continua dezvoltare, paralel cu evolutia Terapia SM este in continua dezvoltare, paralel cu evolutia intelegerii mecanismelor etio-patogenice ale bolii;intelegerii mecanismelor etio-patogenice ale bolii;

• O terapie corecta si completa este necesara pentru O terapie corecta si completa este necesara pentru asigurarea calitatii vietii si a prognosticului vital si asigurarea calitatii vietii si a prognosticului vital si dizabilitantdizabilitant

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