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Sperimentazione clinica per la malattia di Parkinson che utilizza HB-adMSC allogenici (PD precoce e moderata)

14 maggio 2026 aggiornato da: Hope Biosciences Research Foundation

Uno studio randomizzato, in doppio cieco, a centro singolo, di fase 2, sull'efficacia e sulla sicurezza di HB-adMSC allogenici vs placebo per il trattamento di pazienti con malattia di Parkinson

Questo è uno studio randomizzato, in doppio cieco, a centro singolo, di fase 2 per valutare l'efficacia e la sicurezza di più HB-adMSC allogenici rispetto al placebo per il trattamento della malattia di Parkinson.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Lo studio include un periodo di screening fino a 4 settimane, un periodo di trattamento di 32 settimane e un periodo di follow-up sulla sicurezza di 20 settimane dopo l'ultima somministrazione del prodotto sperimentale.

Questa sperimentazione clinica sarà aperta all'arruolamento di 60 partecipanti idonei con diagnosi di malattia di Parkinson. Il reclutamento dei pazienti sarà condotto dal team dello studio, se i partecipanti idonei vengono identificati in base a criteri di ammissibilità, verrà programmata una visita di screening. Il modulo di consenso informato sarà consegnato ai partecipanti allo studio e firmato prima di qualsiasi procedura di studio. Il modulo di consenso informato includerà informazioni sulla sperimentazione clinica e alcuni aspetti dovrebbero essere considerati durante questo processo.

Dopo aver ottenuto il consenso informato, ogni partecipante deve completare le seguenti visite.

  • Visita 1 - Screening, durante questa visita, il ricercatore principale prenderà la decisione di determinare se il partecipante sottoposto a screening è idoneo e se è possibile programmare la visita successiva. Una volta che il ricercatore principale ha valutato l'ammissibilità del soggetto sottoposto a screening (fino a 28 giorni), verrà condotto un processo di randomizzazione per assegnare al soggetto idoneo HB-adMSC allogeniche o placebo. La randomizzazione si applicherà solo ai soggetti idonei. Se un partecipante allo studio non soddisfa i criteri di inclusione ed esclusione durante il processo di screening, sarà considerato Screen Failure (SF) e la randomizzazione non è richiesta.
  • Visita 2 - Infusione 1, (linea di base): questa visita verrà utilizzata come punto di partenza per il confronto dei dati del partecipante. Durante questa visita, i partecipanti idonei allo studio riceveranno la sua prima somministrazione del prodotto sperimentale o placebo con monitoraggio dei segni vitali per un totale di 2 ore dopo l'esposizione al farmaco. Altre valutazioni di studio saranno completate come parte di questa visita.
  • Visita 3 - Infusione 2: circa 4 settimane dopo la somministrazione iniziale del prodotto sperimentale, questa visita deve essere completata. Altre valutazioni di studio saranno completate come parte di questa visita.
  • Visita 4 - Infusione 3: circa 8 settimane dopo la somministrazione iniziale del prodotto sperimentale, questa visita deve essere completata. Altre valutazioni di studio saranno completate come parte di questa visita.
  • Visita 5 - Infusione 4: circa 12 settimane dopo la somministrazione iniziale del prodotto sperimentale, questa visita deve essere completata. Altre valutazioni di studio saranno completate come parte di questa visita.
  • Visita 6 - Infusione 5: circa 16 settimane dopo la somministrazione iniziale del prodotto sperimentale, questa visita deve essere completata. Altre valutazioni di studio saranno completate come parte di questa visita.
  • Visita 7 - Infusione 6: circa 20 settimane dopo la somministrazione iniziale del prodotto sperimentale, questa visita deve essere completata. Altre valutazioni di studio saranno completate come parte di questa visita.
  • Telefonata - Follow-up sulla sicurezza: circa 24 settimane dopo la somministrazione iniziale del prodotto sperimentale, i partecipanti attivi allo studio completeranno un follow-up telefonico.
  • Telefonata - Follow-up sulla sicurezza: circa 32 settimane dopo la somministrazione iniziale del prodotto sperimentale, i partecipanti attivi allo studio completeranno un follow-up telefonico.
  • Visita 8 - Fine dello studio, durante questa visita finale (circa 52 settimane dopo la settimana 0) verrà eseguito un gruppo completo di valutazioni dello studio per valutare la sicurezza e l'efficacia delle somministrazioni di HB-adMSC allogeniche o placebo.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

60

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Texas
      • Sugar Land, Texas, Stati Uniti, 77478
        • Hope Biosciences Stem Cell Research Foundation

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 45 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

  • Un partecipante allo studio sarà idoneo per l'inclusione in questo studio solo se si applicano tutti i seguenti criteri:

    1. Partecipanti di sesso maschile e femminile di età compresa tra 45 e 80 anni.
    2. Alla visita di screening, i partecipanti allo studio devono avere un punteggio MDS-UPDRS parte II compreso tra 7 e 28.
    3. I partecipanti allo studio devono avere un punteggio MDS-UPDRS parte III compreso tra 20 e 57 durante la visita di screening.
    4. Il dosaggio totale di carbidopa/levodopa deve essere inferiore a 1200 mg al giorno per i partecipanti allo studio.
    5. La dose totale equivalente di Levodopa per i partecipanti allo studio deve essere inferiore a 1400 mg al giorno.
    6. Al partecipante allo studio deve essere stata diagnosticata la malattia di Parkinson precoce e/o moderata almeno 2 anni prima della partecipazione allo studio.
    7. I partecipanti allo studio dovrebbero essere in grado di leggere, comprendere e fornire il consenso scritto.
    8. Consenso informato firmato volontariamente ottenuto prima dell'esecuzione di qualsiasi procedura correlata alla sperimentazione clinica.
    9. Le partecipanti allo studio di sesso femminile non devono essere incinte o pianificare una gravidanza durante la partecipazione allo studio e per 6 mesi dopo l'ultima somministrazione del prodotto sperimentale.
    10. I partecipanti di sesso maschile se i loro partner sessuali possono rimanere incinti devono utilizzare un metodo contraccettivo durante la partecipazione allo studio e per 6 mesi dopo l'ultima somministrazione del prodotto studiato.
    11. Il partecipante allo studio è in grado e disposto a rispettare i requisiti di questo studio clinico.

Criteri di esclusione:

  • Un partecipante allo studio non sarà idoneo per l'inclusione in questa sperimentazione clinica se si applica uno dei seguenti criteri:

    1. Gravidanza, allattamento. Donne in età fertile che non sono in stato di gravidanza ma che non adottano misure contraccettive efficaci.
    2. Partecipanti allo studio con malattia di Parkinson avanzata descritta come disabilità grave, costretta a letto o su sedia a rotelle.
    3. - Il partecipante allo studio ha qualsiasi tumore maligno attivo, inclusa l'evidenza di basale cutaneo, carcinoma a cellule squamose o melanoma.
    4. Il partecipante allo studio ha conosciuto dipendenza o dipendenza da alcol o ha un uso o abuso di sostanze attuali.

    5. Il partecipante allo studio ha 1 o più condizioni mediche concomitanti significative (verificate da cartelle cliniche), tra cui le seguenti:

      • Diabete mellito scarsamente controllato (PCDM) definito come storia di carente standard di trattamento terapeutico e/o glicemia pre-prandiale >130 mg/dl durante la visita di screening o glicemia post-prandiale >200 mg/dl.
      • Storia medica della diagnosi di malattia renale cronica (CKD) e/o risultati dello screening di eGFR <59 ml/min/1,73 m2.
      • Presenza di insufficienza cardiaca di Classe III/IV della New York Heart Association (NYHA) durante la visita di screening.
      • Qualsiasi storia medica di infarto del miocardio in uno qualsiasi dei diversi tipi, come infarto del miocardio con sopraslivellamento del tratto ST (STEMI) o infarto del miocardio senza sopraslivellamento del tratto ST (NSTEMI), spasmo coronarico o angina instabile.
      • Anamnesi di ipertensione incontrollata definita come trattamento standard carente e/o pressione arteriosa > 180/120 mm/Hg durante la visita di screening.
      • Anamnesi di trombofilia ereditaria, recente intervento di chirurgia generale maggiore (entro 12 mesi prima dello screening), paralisi degli arti inferiori dovuta a lesione del midollo spinale, frattura del bacino, delle anche o del femore, tumore del polmone, del cervello, del sistema linfatico, ginecologico ( ovaio o utero), o del tratto gastrointestinale (come il pancreas o lo stomaco).
      • Storia della chirurgia cerebrale per il morbo di Parkinson.
    6. Il partecipante allo studio ha ricevuto qualsiasi trattamento con cellule staminali entro 6 mesi prima della prima dose di prodotto sperimentale diverso dalle cellule staminali prodotte da Hope Biosciences.
    7. Ricevere qualsiasi terapia sperimentale o qualsiasi terapia approvata per uso sperimentale entro 1 anno prima della prima dose del prodotto sperimentale diverso dai vaccini COVID-19.

    8. Il partecipante allo studio presenta un'anomalia di laboratorio durante lo screening, tra cui:

      • Conta dei globuli bianchi < 3000/mm3
      • Conta piastrinica < 80.000 mm3
      • Conta assoluta dei neutrofili < 1500/mm3
      • Alanina aminotransferasi (ALT) o aspartato aminotransferasi (AST) 10 limite superiore della norma (ULN) x 1,5
    9. Il partecipante allo studio presenta qualsiasi altra anomalia di laboratorio o condizione medica che, secondo l'opinione dello sperimentatore, rappresenta un rischio per la sicurezza o impedirà al soggetto di completare lo studio.
    10. È improbabile che il partecipante allo studio completi lo studio o aderisca alle procedure dello studio.
    11. Partecipante allo studio con epatite virale acuta o cronica concomitante nota B o C o infezione da virus dell'immunodeficienza umana (HIV).
    12. Il partecipante allo studio ha una condizione psichiatrica precedentemente diagnosticata che secondo l'opinione dello sperimentatore può influenzare le autovalutazioni.
    13. - Partecipante allo studio con qualsiasi infezione sistemica che richieda un trattamento con antibiotici, antivirali o antimicotici entro 30 giorni prima della prima dose del prodotto sperimentale.
    14. Partecipanti allo studio di sesso maschile che intendono donare lo sperma durante lo studio o entro 6 mesi dall'ultima dose. Pazienti di sesso femminile che intendono donare ovociti o sottoporsi a trattamento di fecondazione in vitro durante lo studio o entro 6 mesi dall'ultima dose.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: HB-adMSC allogeniche.

Biologico/Vaccino: HB-adMSC allogenici

Gli HB-adMSC allogenici saranno somministrati per via endovenosa ai partecipanti allo studio che si qualificano.

Altri nomi: Cellule staminali mesenchimali derivate adipose allogeniche di Hope Biosciences.
Biologico: Biologico/Vaccino: HB-adMSC allogenici
Gli HB-adMSC verranno somministrati per via endovenosa ai partecipanti allo studio che si qualificano.
Altri nomi:
  • Cellule staminali mesenchimali derivate adipose di Hope Biosciences allogeniche.
Altro: Placebo
Soluzione salina sterile 0,9%
Altri nomi:
  • Il placebo verrà somministrato per via endovenosa per studiare i partecipanti che si qualificano.
Comparatore placebo: Placebo

Il placebo verrà somministrato per via endovenosa per studiare i partecipanti che si qualificano.

Altri nomi: Soluzione salina sterile 0,9%
Biologico: Biologico/Vaccino: HB-adMSC allogenici
Gli HB-adMSC verranno somministrati per via endovenosa ai partecipanti allo studio che si qualificano.
Altri nomi:
  • Cellule staminali mesenchimali derivate adipose di Hope Biosciences allogeniche.
Altro: Placebo
Soluzione salina sterile 0,9%
Altri nomi:
  • Il placebo verrà somministrato per via endovenosa per studiare i partecipanti che si qualificano.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in MDS-UPDRS Part III Total Score
Lasso di tempo: 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 (Statistical Analysis - RMA Model)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Changes From Baseline in MDS-UPDRS Part II (Statistical Analysis - RMA Model)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in MDS-UPDRS Part I Total Score
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Change From Baseline in SF-36 (Average Physical Functioning) Total Score
Lasso di tempo: 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
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score
Lasso di tempo: 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
Change From Baseline in SF-36 (Average Social Functioning) Total Score
Lasso di tempo: 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
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score
Lasso di tempo: 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
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score
Lasso di tempo: 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
Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health) Total Score
Lasso di tempo: 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
Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score
Lasso di tempo: 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
Change From Baseline in SF-36 (Average General Health) Total Score (Statistical Analysis - RMA Model)
Lasso di tempo: 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
Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Statistical Analysis - RMA Model)
Lasso di tempo: 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
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Statistical Analysis - RMA Model)
Lasso di tempo: 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
Change From Baseline in SF-36 (Average Social Functioning) Total Score (Statistical Analysis - RMA Model)
Lasso di tempo: 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
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Statistical Analysis - RMA Model)
Lasso di tempo: 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
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Statistical Analysis - RMA Model)
Lasso di tempo: 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
Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health ) Total Score (Statistical Analysis - RMA Model)
Lasso di tempo: 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
Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score (Statistical Analysis - RMA Model)
Lasso di tempo: 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
Change From Baseline in SF-36 (Average General Health) Total Score (Bayesian Statistical Analysis - RMA Model)
Lasso di tempo: 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
Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Bayesian Statistical Analysis - RMA Model)
Lasso di tempo: 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
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Bayesian Statistical Analysis - RMA Model)
Lasso di tempo: 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
Change From Baseline in SF-36 (Average Social Functioning) Total Score (Bayesian Statistical Analysis - RMA Model)
Lasso di tempo: 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
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Bayesian Statistical Analysis - RMA Model)
Lasso di tempo: 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
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Bayesian Statistical Analysis - RMA Model)
Lasso di tempo: 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
Change From Baseline in SF-36 (Average Role Limitations Due To Physical Health) Total Score (Bayesian Statistical Analysis - RMA Model)
Lasso di tempo: 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
Change From Baseline in SF-36 (Average Role Limitations Due To Emotional Problems) Total Score (Bayesian Statistical Analysis - RMA Model)
Lasso di tempo: 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
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Raw Scores
Lasso di tempo: 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.
Baseline to Weeks 52
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Statistical Analysis - RMA Model)
Lasso di tempo: 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.
Baseline to Weeks 52
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Bayesian Statistical Analysis - RMA Model)
Lasso di tempo: 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.
Baseline to Weeks 52
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores
Lasso di tempo: 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
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Statistical Analysis - RMA Model)
Lasso di tempo: 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
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Bayesian Statistical Analysis - RMA Model)
Lasso di tempo: 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
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
Lasso di tempo: 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.
Baseline to Weeks 52
Change From Baseline in Visual Analog Scale (VAS) Pain Raw Scores
Lasso di tempo: 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) Pain Scores (Statistical Analysis - RMA Model)
Lasso di tempo: 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) Pain Scores (Bayesian Statistical Analysis - RMA Model)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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 - %)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Baseline to Weeks 52
Physical examination - by treatment week - Summary - Safety analysis set
Baseline to Weeks 52
Physical Examination - by Treatment Week - Cardiovascular
Lasso di tempo: Baseline to Weeks 52
Physical examination - by treatment week - Summary - Safety analysis set
Baseline to Weeks 52
Physical Examination - by Treatment Week - HEENT
Lasso di tempo: 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
Lasso di tempo: Baseline to Weeks 52
Physical examination - by treatment week - Summary - Safety analysis set
Baseline to Weeks 52
Physical Examination - by Treatment Week - Musculoskeletal
Lasso di tempo: Baseline to Weeks 52
Physical examination - by treatment week - Summary - Safety analysis set
Baseline to Weeks 52
Physical Examination - by Treatment Week - Neurological
Lasso di tempo: Baseline to Weeks 52
Physical examination - by treatment week - Summary - Safety analysis set
Baseline to Weeks 52
Physical Examination - by Treatment Week - Respiratory
Lasso di tempo: Baseline to Weeks 52
Physical examination - by treatment week - Summary - Safety analysis set
Baseline to Weeks 52
Physical Examination - by Treatment Week - Skin
Lasso di tempo: Baseline to Weeks 52
Physical examination - by treatment week - Summary - Safety analysis set
Baseline to Weeks 52

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hope Biosciences Research Foundation

Collaboratori

Hope Biosciences

Investigatori

  • Investigatore principale: Djamchid Lotfi, MD, Hope Biosciences Stem Cell Research Foundation

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

16 luglio 2021

Completamento primario (Effettivo)

3 ottobre 2025

Completamento dello studio (Effettivo)

3 ottobre 2025

Date di iscrizione allo studio

Primo inviato

16 luglio 2021

Primo inviato che soddisfa i criteri di controllo qualità

2 agosto 2021

Primo Inserito (Effettivo)

6 agosto 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • HBPD04

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Austria

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

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