Klinisk studie for Parkinsons sykdom ved bruk av allogene HB-adMSCs (tidlig og moderat PD)
En randomisert, dobbeltblind, enkeltsenter, fase 2, effekt- og sikkerhetsstudie av allogene HB-adMSCs vs placebo for behandling av pasienter med Parkinsons sykdom
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studien inkluderer en screeningperiode på opptil 4 uker, en 32-ukers behandlingsperiode og en sikkerhetsoppfølgingsperiode på 20 uker etter siste administrasjon av undersøkelsesproduktet.
Denne kliniske studien vil være åpen for å registrere 60 kvalifiserte deltakere diagnostisert med Parkinsons sykdom. Pasientenes rekruttering vil bli utført av studieteamet, hvis kvalifiserte deltakere identifiseres basert på kvalifikasjonskriterier, vil et screeningbesøk bli planlagt. Skjema for informert samtykke vil bli gitt til studiedeltakerne og signert før eventuelle studieprosedyrer. Skjema for informert samtykke vil inneholde informasjon om den kliniske utprøvingen, og noen aspekter bør vurderes under denne prosessen.
Etter at informert samtykke er innhentet, bør hver deltaker gjennomføre følgende besøk.
- Besøk 1 - Screening, under dette besøket vil hovedetterforskeren ta avgjørelsen for å avgjøre om den screenede deltakeren er kvalifisert og om neste besøk kan planlegges. Når hovedetterforskeren har evaluert kvalifiseringen til den screenede personen (opptil 28 dager), vil en randomiseringsprosess bli utført for å tildele den kvalifiserte personen enten allogene HB-adMSCs eller placebo. Randomisering vil kun gjelde for kvalifiserte fag. Hvis en studiedeltaker ikke oppfyller inklusjons- og eksklusjonskriteriene under screeningsprosessen, vil han/hun bli ansett som Screen Failure (SF) og randomisering er ikke nødvendig.
- Besøk 2 - Infusjon 1, (Baseline): dette besøket vil bli brukt som utgangspunkt for sammenligning av deltakerdata. Under dette besøket vil kvalifiserte studiedeltakere motta sin første undersøkelsesproduktadministrasjon eller placebo med overvåking av vitale tegn i totalt 2 timer etter legemiddeleksponering. Andre studieevalueringer vil bli fullført som en del av dette besøket.
- Besøk 3 - Infusjon 2: ca. 4 uker etter den første undersøkelsesproduktadministrasjonen bør dette besøket fullføres. Andre studieevalueringer vil bli fullført som en del av dette besøket.
- Besøk 4 - Infusjon 3: ca. 8 uker etter den innledende undersøkelsesproduktadministrasjonen bør dette besøket fullføres. Andre studieevalueringer vil bli fullført som en del av dette besøket.
- Besøk 5 - Infusjon 4: ca. 12 uker etter den første undersøkelsesproduktadministrasjonen bør dette besøket fullføres. Andre studieevalueringer vil bli fullført som en del av dette besøket.
- Besøk 6 - Infusjon 5: ca. 16 uker etter den første undersøkelsesproduktadministrasjonen bør dette besøket fullføres. Andre studieevalueringer vil bli fullført som en del av dette besøket.
- Besøk 7 - Infusjon 6: ca. 20 uker etter den første undersøkelsesproduktadministrasjonen bør dette besøket fullføres. Andre studieevalueringer vil bli fullført som en del av dette besøket.
- Telefonsamtale – sikkerhetsoppfølging: ca. 24 uker etter den første undersøkelsesproduktadministrasjonen, vil aktive studiedeltakere gjennomføre en telefonoppfølging.
- Telefonsamtale – sikkerhetsoppfølging: omtrent 32 uker etter den første administrasjonen av undersøkelsesproduktet, vil aktive studiedeltakere gjennomføre en telefonoppfølging.
- Besøk 8 - Slutt på studien, under dette siste besøket (omtrent 52 uker etter uke 0) vil en komplett gruppe studievurderinger bli utført for å evaluere sikkerheten og effekten av allogene HB-adMSCs eller placeboadministrasjoner.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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Texas
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Sugar Land, Texas, Forente stater, 77478
- Hope Biosciences Stem Cell Research Foundation
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Beskrivelse
Inklusjonskriterier:
En studiedeltaker vil være kvalifisert for inkludering i denne studien bare hvis alle følgende kriterier gjelder:
- Mannlige og kvinnelige deltakere 45 - 80 år.
- Ved screeningbesøket må studiedeltakerne ha en MDS-UPDRS del II-score mellom 7 og 28.
- Studiedeltakere må ha en MDS-UPDRS del III-score mellom 20 og 57 under screeningbesøket.
- Den totale dosen av karbidopa/levodopa må være mindre enn 1200 mg per dag for studiedeltakere.
- Den totale Levodopa-ekvivalentdosen for studiedeltakere må være mindre enn 1400 mg per dag.
- Studiedeltakeren må ha blitt diagnostisert med tidlig og/eller moderat Parkinsons sykdom minst 2 år før studiedeltakelsen.
- Studiedeltakere skal kunne lese, forstå og gi skriftlig samtykke.
- Frivillig signert informert samtykke innhentet før noen kliniske utprøvingsrelaterte prosedyrer utføres.
- Kvinnelige studiedeltakere bør ikke være gravide eller planlegge å bli gravide under studiedeltakelsen og i 6 måneder etter siste administrering av undersøkelsesproduktet.
- Mannlige deltakere dersom deres seksuelle partnere kan bli gravide bør bruke en prevensjonsmetode under studiedeltakelsen og i 6 måneder etter siste administrering av det undersøkte produktet.
- Studiedeltakeren er i stand til og villig til å overholde kravene i denne kliniske studien.
Ekskluderingskriterier:
En studiedeltaker vil ikke være kvalifisert for inkludering i denne kliniske studien hvis noen av følgende kriterier gjelder:
- Graviditet, amming. Kvinner i fertil alder som ikke er gravide, men som ikke tar effektive prevensjonstiltak.
- Studiedeltakere med avansert Parkinsons sykdom beskrevet som alvorlig funksjonshemming, rullestolbundet eller sengeliggende.
- Studiedeltakeren har enhver aktiv malignitet, inkludert tegn på kutan basal-, plateepitelkarsinom eller melanom.
- Studiedeltakeren har kjent alkoholavhengighet eller avhengighet eller har nåværende rusmiddelbruk eller -misbruk.
Studiedeltakeren har 1 eller flere betydelige samtidige medisinske tilstander (verifisert av medisinske journaler), inkludert følgende:
- Dårlig kontrollert diabetes mellitus (PCDM) definert som historie med mangelfull standardbehandling og/eller preprandial glukose >130 mg/dl under screeningbesøk eller postprandial glukose >200mg/dl.
- Medisinsk historie med diagnose av kronisk nyresykdom (CKD) og/eller screeningsresultater av eGFR < 59 ml/min/1,73 m2.
- Tilstedeværelse av New York Heart Association (NYHA) klasse III/IV hjertesvikt under screeningbesøk.
- Enhver medisinsk historie med hjerteinfarkt i noen av de forskjellige typene, for eksempel ST-elevasjon hjerteinfarkt (STEMI) eller ikke-ST-forhøyet hjerteinfarkt (NSTEMI), koronar spasme eller ustabil angina.
- Sykehistorie med ukontrollert høyt blodtrykk definert som en mangelfull standardbehandling og/eller blodtrykk > 180/120 mm/Hg under screeningbesøk.
- Medisinsk historie med arvelige trombofilier, nylig større generell kirurgi (innen 12 måneder før screeningen), lammelser i nedre ekstremiteter på grunn av ryggmargsskade, brudd i bekken, hofter eller lårben, kreft i lunge, hjerne, lymfe, gynekologisk system ( eggstokk eller livmor), eller mage-tarmkanalen (som bukspyttkjertel eller mage).
- Historie om hjernekirurgi for Parkinsons sykdom.
- Studiedeltaker har mottatt stamcellebehandling innen 6 måneder før første dose av undersøkelsesproduktet annet enn stamceller produsert av Hope Biosciences.
- Mottak av undersøkelsesterapi eller godkjent terapi for undersøkelsesbruk innen 1 år før første dose av undersøkelsesproduktet annet enn COVID-19-vaksiner.
Studiedeltakeren har en laboratorieavvik under screening, inkludert følgende:
- Antall hvite blodlegemer < 3000/mm3
- Blodplateantall < 80 000 mm3
- Absolutt nøytrofiltall < 1500/mm3
- Alaninaminotransferase (ALT) eller aspartataminotransferase (AST) 10 øvre normalgrense (ULN) x 1,5
- Studiedeltakeren har enhver annen laboratorieavvik eller medisinsk tilstand som, etter utrederens oppfatning, utgjør en sikkerhetsrisiko eller vil forhindre forsøkspersonen i å fullføre studien.
- Det er usannsynlig at studiedeltakeren vil fullføre studien eller følge studieprosedyrene.
- Studiedeltaker med kjent samtidig akutt eller kronisk viral hepatis B eller C eller humant immunsviktvirus (HIV) infeksjon.
- Studiedeltaker har en tidligere diagnostisert psykiatrisk tilstand som etter utrederens oppfatning kan påvirke egenvurderinger.
- Studiedeltaker med en systemisk infeksjon som krever behandling med antibiotika, antivirale midler eller soppdrepende midler innen 30 dager før første dose av undersøkelsesproduktet.
- Mannlige studiedeltakere som planlegger å donere sæd i løpet av studien eller innen 6 måneder etter siste dose. Kvinnelige pasienter som planlegger å donere egg eller gjennomgå in vitro fertiliseringsbehandling under studien eller innen 6 måneder etter siste dose.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Allogene HB-adMSCs.
Biologisk/vaksine: Allogene HB-adMSCs Allogene HB-adMSCs vil bli administrert intravenøst til studiedeltakere som kvalifiserer. Andre navn: Allogeneic Hope Biosciences fettavledede mesenkymale stamceller. |
HB-adMSCs vil bli administrert intravenøst til studiedeltakere som kvalifiserer.
Andre navn:
Steril saltvannsløsning 0,9 %
Andre navn:
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Placebo komparator: Placebo
Placebo vil bli administrert intravenøst til studiedeltakere som kvalifiserer. Andre navn: Steril saltvannsløsning 0,9 % |
HB-adMSCs vil bli administrert intravenøst til studiedeltakere som kvalifiserer.
Andre navn:
Steril saltvannsløsning 0,9 %
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in MDS-UPDRS Part III Total Score
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part III.
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total).
Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe.
The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability).
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
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Change From Baseline in MDS-UPDRS Part III (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part III.
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total).
Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe.
The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability).
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part III (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part III.
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total).
Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe.
The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability).
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part III Score - by Treatment Week
Tidsramme: Baseline to Weeks 52
|
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total).
Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe.
The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability).
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part II Total Score
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part II.The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. |
Baseline to Weeks 52
|
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Changes From Baseline in MDS-UPDRS Part II (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part II.The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. |
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part II (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part II.The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. |
Baseline to Weeks 52
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part II Score - by Treatment Week
Tidsramme: Baseline to Weeks 52
|
The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients.
The MDS-UPDRS scale consists of 4 segments.
Part II tests "Motor Aspects of Experiences of Daily Living".
Each answer to the scale is evaluated by the principal investigator during the study visit.
Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity.
There are 13 items included in Part II.
Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe.
Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability.
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in MDS-UPDRS Part I Total Score
Tidsramme: Baseline to Weeks 52
|
The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. |
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part I (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. |
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part I (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. |
Baseline to Weeks 52
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part I Score - by Treatment Week
Tidsramme: Baseline to Weeks 52
|
The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. |
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part IV Total Score
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part IV.
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part IV tests "Motor Complications", including time spent with dyskinesias and others.
There are 6 items included in Part IV.
Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe.
Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability.
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part IV Total Score (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part IV.
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part IV tests "Motor Complications", including time spent with dyskinesias and others.
There are 6 items included in Part IV.
Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe.
Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability.
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part IV Total Score (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part IV.
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part IV tests "Motor Complications", including time spent with dyskinesias and others.
There are 6 items included in Part IV.
Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe.
Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability.
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part IV Score - by Treatment Week
Tidsramme: Baseline to Weeks 52
|
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part IV tests "Motor Complications", including time spent with dyskinesias and others.
There are 6 items included in Part IV.
Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe.
Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability.
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average General Health) Total Score
Tidsramme: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Physical Functioning) Total Score
Tidsramme: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score
Tidsramme: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Social Functioning) Total Score
Tidsramme: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score
Tidsramme: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score
Tidsramme: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health) Total Score
Tidsramme: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score
Tidsramme: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average General Health) Total Score (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Social Functioning) Total Score (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health ) Total Score (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average General Health) Total Score (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
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Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
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Change From Baseline in SF-36 (Average Social Functioning) Total Score (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Role Limitations Due To Physical Health) Total Score (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Role Limitations Due To Emotional Problems) Total Score (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Raw Scores
Tidsramme: Baseline to Weeks 52
|
The Parkinson's Disease Fatigue Scale (PFS-16) is a patient-rated scale that measures fatigue in Parkinson's patients.
It has 7 items on the measurement of presence of fatigue and 9 items on its impact on daily function.
It can be used to assess levels of fatigue and measure any changes that treatment or lifestyle changes may affect.
There are five answer choices for each item: Strongly disagree (1 point), Disagree (2 points), Do not agree or disagree (3 points), Agree (4 points), and Strongly agree (5 points).
The PFS-16 score ranges from 16 (minimum) to 80 (maximum).
Higher scores represent a worse outcome.
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Baseline to Weeks 52
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Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in PFS-16 scores.
The Parkinson's Disease Fatigue Scale (PFS-16) is a patient-rated scale that measures fatigue in Parkinson's patients.
It has 7 items on the measurement of presence of fatigue and 9 items on its impact on daily function.
It can be used to assess levels of fatigue and measure any changes that treatment or lifestyle changes may affect.
There are five answer choices for each item: Strongly disagree (1 point), Disagree (2 points), Do not agree or disagree (3 points), Agree (4 points), and Strongly agree (5 points).
The PFS-16 score ranges from 16 (minimum) to 80 (maximum).
Higher scores represent a worse outcome.
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Baseline to Weeks 52
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Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in PFS-16 scores.
The Parkinson's Disease Fatigue Scale (PFS-16) is a patient-rated scale that measures fatigue in Parkinson's patients.
It has 7 items on the measurement of presence of fatigue and 9 items on its impact on daily function.
It can be used to assess levels of fatigue and measure any changes that treatment or lifestyle changes may affect.
There are five answer choices for each item: Strongly disagree (1 point), Disagree (2 points), Do not agree or disagree (3 points), Agree (4 points), and Strongly agree (5 points).
The PFS-16 score ranges from 16 (minimum) to 80 (maximum).
Higher scores represent a worse outcome.
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Baseline to Weeks 52
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Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in PDQ-39 SI raw scores.
The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month.
The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being.
Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always).
The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100).
To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100).
Higher scores represent a worse outcome.
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Baseline to Weeks 52
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Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in PDQ-39 SI raw scores.
The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month.
The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being.
Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always).
The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100).
To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100).
Higher scores represent a worse outcome.
|
Baseline to Weeks 52
|
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Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in PDQ-39 SI raw scores.
The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month.
The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being.
Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always).
The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100).
To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100).
Higher scores represent a worse outcome.
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Baseline to Weeks 52
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Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores - by Treatment Week
Tidsramme: Baseline to Weeks 52
|
The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month.
The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being.
Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always).
The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100).
To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100).
Higher scores represent a worse outcome.
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Baseline to Weeks 52
|
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Change From Baseline in Visual Analog Scale (VAS) Pain Raw Scores
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in VAS Pain raw scores.
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" used to measure intensity in pain and various other areas.
The patient marks a point on the line corresponding to their pain intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm.
Higher scores represent worse outcomes.
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Baseline to Weeks 52
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Change From Baseline in Visual Analog Scale (VAS) Pain Scores (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in VAS Pain raw scores.
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" used to measure intensity in pain and various other areas.
The patient marks a point on the line corresponding to their pain intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm.
Higher scores represent worse outcomes.
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Baseline to Weeks 52
|
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Change From Baseline in Visual Analog Scale (VAS) Pain Scores (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in VAS Pain raw scores.
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" used to measure intensity in pain and various other areas.
The patient marks a point on the line corresponding to their pain intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm.
Higher scores represent worse outcomes.
|
Baseline to Weeks 52
|
|
Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Raw Scores
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in VAS Muscle Spasm raw scores.
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no muscle spasms" and "worst muscle spasms" used to measure intensity in muscle spasms and various other areas.
The patient marks a point on the line corresponding to their muscle spasm intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm.
Higher scores represent worse outcomes.
|
Baseline to Weeks 52
|
|
Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Scores (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in VAS Muscle Spasm raw scores.
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no muscle spasms" and "worst muscle spasms" used to measure intensity in muscle spasms and various other areas.
The patient marks a point on the line corresponding to their muscle spasm intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm.
Higher scores represent worse outcomes.
|
Baseline to Weeks 52
|
|
Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Scores (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in VAS Muscle Spasm raw scores.
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no muscle spasms" and "worst muscle spasms" used to measure intensity in muscle spasms and various other areas.
The patient marks a point on the line corresponding to their muscle spasm intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm.
Higher scores represent worse outcomes.
|
Baseline to Weeks 52
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total VAS Scores - by Treatment Week
Tidsramme: Baseline to Weeks 52
|
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" in the Pain section and "No muscle spasm" and "worst muscle spasm" in the Muscle Spasm section, used to measure intensity in pain and various other areas.
The patient marks a point on the line corresponding to their pain intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm for each section.
The total score is achieved by summing the two individual scores.
Higher scores represent worse outcomes.
|
Baseline to Weeks 52
|
|
Summary of PD Medication Dose Changes by Visit
Tidsramme: Baseline to Weeks 52
|
The following table depicts the count of participants that decreased, increased, or did not change their Parkinson's disease medication dosage over the course of the study at various timepoints.
The safety analysis set (30 patients in Placebo, 30 patients in HB-adMSCs) was assessed at the various timepoints.
|
Baseline to Weeks 52
|
|
Summary of PD Medication Reinstatement by Visit
Tidsramme: Baseline to Weeks 52
|
The table prior to this one depicts the count of participants that decreased, increased, or did not change their Parkinson's disease medication dosage over the course of the study at various timepoints.
This table depicts the count of participants that reinstated their dose of Parkinson's disease medications after decreasing it throughout the clinical trial.
The safety analysis set (30 patients in Placebo, 30 patients in HB-adMSCs) was assessed at the various timepoints.
|
Baseline to Weeks 52
|
|
Treatment Emergent Adverse Events (Subjects With >= 1 Adverse Event) - Summary - Safety Analysis Set
Tidsramme: Baseline to Week 24
|
Unit (# of participants) - Treatment emergent Adverse events (Subjects with >= 1 adverse event) - Summary - Safety analysis set.
Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1).
A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
Baseline to Week 24
|
|
Treatment Emergent Adverse Events (Serious AEs) - Summary - Safety Analysis Set
Tidsramme: Baseline to Week 24
|
Unit (# of participants) - Treatment emergent Adverse events (Serious AEs) - Summary - Safety analysis set.
Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1).
A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
Baseline to Week 24
|
|
Change From Baseline Laboratory Values - CBC (x10^9 Cells/L) [Time Frame: Baseline to Week 52]
Tidsramme: Baseline to Weeks 52
|
Unit (x10^9 cells/L) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CBC (%) [Time Frame: Baseline to Week 52]
Tidsramme: Baseline to Weeks 52
|
Unit (%) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CBC (g/dL) [Time Frame: Baseline to Week 52]
Tidsramme: Baseline to Weeks 52
|
Unit (g/dL) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CBC (pg) [Time Frame: Baseline to Week 52]
Tidsramme: Baseline to Weeks 52
|
Unit (pg) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CBC (fL) [Time Frame: Baseline to Week 52]
Tidsramme: Baseline to Weeks 52
|
Unit (fL) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CBC (10^12/L) [Time Frame: Baseline to Week 52]
Tidsramme: Baseline to Weeks 52
|
Unit (10^12/L) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CMP (g/dL) [Time Frame: Baseline to Week 52]
Tidsramme: Baseline to Weeks 52
|
Unit (g/dL) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CMP (Ratio) [Time Frame: Baseline to Week 52]
Tidsramme: Baseline to Weeks 52
|
Unit (Ratio) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CMP (IU/L) [Time Frame: Baseline to Week 52]
Tidsramme: Baseline to Weeks 52
|
Unit (IU/L) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CMP (mg/dL) [Time Frame: Baseline to Week 52]
Tidsramme: Baseline to Weeks 52
|
Unit (mg/dL) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CMP (mmol/L) [Time Frame: Baseline to Week 52]
Tidsramme: Baseline to Weeks 52
|
Unit (mmol/L) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CMP (mL/Min/1.73 m^2) [Time Frame: Baseline to Week 52]
Tidsramme: Baseline to Weeks 52
|
Unit (mL/min/1.73
m^2) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - Coagulation Panel (Ratio) [Time Frame: Baseline to Week 52]
Tidsramme: Baseline to Weeks 52
|
Unit (Ratio) - Change From Baseline Clinical Laboratory Coagulation Panel by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - Coagulation Panel (Sec.) [Time Frame: Baseline to Week 52]
Tidsramme: Baseline to Weeks 52
|
Unit (sec.) - Change From Baseline Clinical Laboratory Coagulation Panel by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure - mmHg)
Tidsramme: Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Heart Rate - Beats/Min)
Tidsramme: Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Oxygen Saturation - %)
Tidsramme: Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Respiration Rate - Breaths/Min)
Tidsramme: Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure - mmHg)
Tidsramme: Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Temperature - Celsius)
Tidsramme: Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Weight - kg)
Tidsramme: Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Abdomen
Tidsramme: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Cardiovascular
Tidsramme: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - HEENT
Tidsramme: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set - Head, Eyes, Ears, Nose, and Throat
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Lymph Node
Tidsramme: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Musculoskeletal
Tidsramme: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Neurological
Tidsramme: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Respiratory
Tidsramme: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Skin
Tidsramme: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Djamchid Lotfi, MD, Hope Biosciences Stem Cell Research Foundation
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Meirelles Lda S, Fontes AM, Covas DT, Caplan AI. Mechanisms involved in the therapeutic properties of mesenchymal stem cells. Cytokine Growth Factor Rev. 2009 Oct-Dec;20(5-6):419-27. doi: 10.1016/j.cytogfr.2009.10.002. Epub 2009 Nov 18.
- Garretti F, Agalliu D, Lindestam Arlehamn CS, Sette A, Sulzer D. Autoimmunity in Parkinson's Disease: The Role of alpha-Synuclein-Specific T Cells. Front Immunol. 2019 Feb 25;10:303. doi: 10.3389/fimmu.2019.00303. eCollection 2019.
- Musial-Wysocka A, Kot M, Majka M. The Pros and Cons of Mesenchymal Stem Cell-Based Therapies. Cell Transplant. 2019 Jul;28(7):801-812. doi: 10.1177/0963689719837897. Epub 2019 Apr 24.
- Giannini EG, Testa R, Savarino V. Liver enzyme alteration: a guide for clinicians. CMAJ. 2005 Feb 1;172(3):367-79. doi: 10.1503/cmaj.1040752.
- Kalia LV, Lang AE. Parkinson's disease. Lancet. 2015 Aug 29;386(9996):896-912. doi: 10.1016/S0140-6736(14)61393-3. Epub 2015 Apr 19.
- Dimarino AM, Caplan AI, Bonfield TL. Mesenchymal stem cells in tissue repair. Front Immunol. 2013 Sep 4;4:201. doi: 10.3389/fimmu.2013.00201.
- Cuenca L, Gil-Martinez AL, Cano-Fernandez L, Sanchez-Rodrigo C, Estrada C, Fernandez-Villalba E, Herrero MT. Parkinson's disease: a short story of 200 years. Histol Histopathol. 2019 Jun;34(6):573-591. doi: 10.14670/HH-18-073. Epub 2018 Dec 12.
- Goetz CG. The history of Parkinson's disease: early clinical descriptions and neurological therapies. Cold Spring Harb Perspect Med. 2011 Sep;1(1):a008862. doi: 10.1101/cshperspect.a008862.
- Stoker TB, Greenland JC, editors. Parkinson's Disease: Pathogenesis and Clinical Aspects [Internet]. Brisbane (AU): Codon Publications; 2018 Dec 21. Available from http://www.ncbi.nlm.nih.gov/books/NBK536721/
- Armstrong MJ, Okun MS. Diagnosis and Treatment of Parkinson Disease: A Review. JAMA. 2020 Feb 11;323(6):548-560. doi: 10.1001/jama.2019.22360.
- Tambasco N, Romoli M, Calabresi P. Levodopa in Parkinson's Disease: Current Status and Future Developments. Curr Neuropharmacol. 2018;16(8):1239-1252. doi: 10.2174/1570159X15666170510143821.
- Marsden CD. Problems with long-term levodopa therapy for Parkinson's disease. Clin Neuropharmacol. 1994;17 Suppl 2:S32-44.
- Coppin L, Sokal E, Stephenne X. Thrombogenic Risk Induced by Intravascular Mesenchymal Stem Cell Therapy: Current Status and Future Perspectives. Cells. 2019 Sep 27;8(10):1160. doi: 10.3390/cells8101160.
- Tatsumi K, Ohashi K, Matsubara Y, Kohori A, Ohno T, Kakidachi H, Horii A, Kanegae K, Utoh R, Iwata T, Okano T. Tissue factor triggers procoagulation in transplanted mesenchymal stem cells leading to thromboembolism. Biochem Biophys Res Commun. 2013 Feb 8;431(2):203-9. doi: 10.1016/j.bbrc.2012.12.134. Epub 2013 Jan 9.
- Tan EK, Chao YX, West A, Chan LL, Poewe W, Jankovic J. Parkinson disease and the immune system - associations, mechanisms and therapeutics. Nat Rev Neurol. 2020 Jun;16(6):303-318. doi: 10.1038/s41582-020-0344-4. Epub 2020 Apr 24.
- Ra JC, Shin IS, Kim SH, Kang SK, Kang BC, Lee HY, Kim YJ, Jo JY, Yoon EJ, Choi HJ, Kwon E. Safety of intravenous infusion of human adipose tissue-derived mesenchymal stem cells in animals and humans. Stem Cells Dev. 2011 Aug;20(8):1297-308. doi: 10.1089/scd.2010.0466. Epub 2011 Mar 17.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HBPD04
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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