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Badanie kliniczne choroby Parkinsona z użyciem allogenicznych HB-adMSC (wczesna i umiarkowana PD)

14 maja 2026 zaktualizowane przez: Hope Biosciences Research Foundation

Randomizowane, podwójnie ślepe, jednoośrodkowe badanie fazy 2 dotyczące skuteczności i bezpieczeństwa stosowania allogenicznych HB-adMSC w porównaniu z placebo w leczeniu pacjentów z chorobą Parkinsona

Jest to randomizowane, podwójnie ślepe, jednoośrodkowe badanie fazy 2 mające na celu ocenę skuteczności i bezpieczeństwa wielu allogenicznych HB-adMSC w porównaniu z placebo w leczeniu choroby Parkinsona.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

Badanie obejmuje okres przesiewowy trwający do 4 tygodni, 32-tygodniowy okres leczenia oraz 20-tygodniowy okres obserwacji bezpieczeństwa po podaniu ostatniego badanego produktu.

To badanie kliniczne będzie otwarte i obejmie 60 kwalifikujących się uczestników, u których zdiagnozowano chorobę Parkinsona. Rekrutacja pacjentów będzie prowadzona przez zespół badawczy, jeśli kwalifikujący się uczestnicy zostaną zidentyfikowani na podstawie kryteriów kwalifikacyjnych, zostanie zaplanowana wizyta przesiewowa. Formularz świadomej zgody zostanie przekazany uczestnikom badania i podpisany przed rozpoczęciem jakichkolwiek procedur badawczych. Formularz świadomej zgody będzie zawierał informacje o badaniu klinicznym, a podczas tego procesu należy wziąć pod uwagę niektóre aspekty.

Po uzyskaniu świadomej zgody każdy uczestnik powinien odbyć następujące wizyty.

  • Wizyta 1 - Badanie przesiewowe, podczas tej wizyty główny badacz podejmie decyzję o ustaleniu, czy badany uczestnik kwalifikuje się i czy można zaplanować kolejną wizytę. Po dokonaniu przez głównego badacza oceny kwalifikowalności badanego pacjenta (do 28 dni), zostanie przeprowadzony proces randomizacji w celu przypisania kwalifikującemu się uczestnikowi allogenicznego HB-adMSC lub placebo. Randomizacja będzie miała zastosowanie tylko do kwalifikujących się podmiotów. Jeśli uczestnik badania nie spełni kryteriów włączenia i wyłączenia podczas procesu przesiewowego, zostanie uznany za niepowodzenie badania (SF) i randomizacja nie jest wymagana.
  • Wizyta 2 – Infuzja 1, (linia bazowa): ta wizyta zostanie wykorzystana jako punkt wyjścia do porównania danych uczestnika. Podczas tej wizyty kwalifikujący się uczestnicy badania otrzymają po raz pierwszy badany produkt lub placebo z monitorowaniem parametrów życiowych przez łącznie 2 godziny po ekspozycji na lek. Inne oceny badań zostaną zakończone w ramach tej wizyty.
  • Wizyta 3 – Infuzja 2: po około 4 tygodniach od podania początkowego produktu badanego ta wizyta powinna się zakończyć. Inne oceny badań zostaną zakończone w ramach tej wizyty.
  • Wizyta 4 – Infuzja 3: po około 8 tygodniach od podania początkowego produktu badanego ta wizyta powinna się zakończyć. Inne oceny badań zostaną zakończone w ramach tej wizyty.
  • Wizyta 5 – Infuzja 4: po około 12 tygodniach od podania początkowego produktu badanego ta wizyta powinna się zakończyć. Inne oceny badań zostaną zakończone w ramach tej wizyty.
  • Wizyta 6 - Infuzja 5: około 16 tygodni po pierwszym podaniu produktu badanego ta wizyta powinna się zakończyć. Inne oceny badań zostaną zakończone w ramach tej wizyty.
  • Wizyta 7 – Infuzja 6: po około 20 tygodniach od podania początkowego produktu badanego ta wizyta powinna zostać zakończona. Inne oceny badań zostaną zakończone w ramach tej wizyty.
  • Rozmowa telefoniczna – kontrola bezpieczeństwa: około 24 tygodnie po podaniu początkowego produktu badanego aktywni uczestnicy badania przeprowadzą rozmowę telefoniczną.
  • Rozmowa telefoniczna – kontrola bezpieczeństwa: około 32 tygodnie po podaniu początkowego produktu badanego aktywni uczestnicy badania przeprowadzą rozmowę telefoniczną.
  • Wizyta 8 — koniec badania, podczas tej ostatniej wizyty (około 52 tygodni po tygodniu 0) zostanie przeprowadzona kompletna grupa ocen badania w celu oceny bezpieczeństwa i skuteczności podawania allogenicznych HB-adMSC lub placebo.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

60

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Texas
      • Sugar Land, Texas, Stany Zjednoczone, 77478
        • Hope Biosciences Stem Cell Research Foundation

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

45 lat do 80 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Opis

Kryteria przyjęcia:

  • Uczestnik badania będzie kwalifikował się do włączenia do tego badania tylko wtedy, gdy zostaną spełnione wszystkie poniższe kryteria:

    1. Uczestnicy płci męskiej i żeńskiej w wieku 45 - 80 lat.
    2. Podczas wizyty przesiewowej uczestnicy badania muszą mieć wynik części II MDS-UPDRS między 7 a 28.
    3. Uczestnicy badania muszą mieć podczas wizyty przesiewowej wynik MDS-UPDRS część III w przedziale od 20 do 57.
    4. Całkowita dawka karbidopy/lewodopy musi być mniejsza niż 1200 mg na dobę dla uczestników badania.
    5. Całkowita dawka ekwiwalentna lewodopy dla uczestników badania musi być mniejsza niż 1400 mg na dobę.
    6. U uczestnika badania zdiagnozowano wczesną i/lub umiarkowaną chorobę Parkinsona co najmniej 2 lata przed udziałem w badaniu.
    7. Uczestnicy badania powinni umieć czytać, rozumieć i wyrażać pisemną zgodę.
    8. Dobrowolnie podpisana świadoma zgoda uzyskana przed wykonaniem jakichkolwiek procedur związanych z badaniem klinicznym.
    9. Uczestniczki badania nie powinny być w ciąży ani planować zajścia w ciążę w trakcie udziału w badaniu i przez 6 miesięcy po ostatnim podaniu badanego produktu.
    10. Uczestnicy płci męskiej, jeśli ich partnerki seksualne mogą zajść w ciążę, powinni stosować metodę antykoncepcji podczas udziału w badaniu i przez 6 miesięcy po ostatnim podaniu badanego produktu.
    11. Uczestnik badania jest w stanie i chce spełnić wymagania tego badania klinicznego.

Kryteria wyłączenia:

  • Uczestnik badania nie będzie kwalifikował się do włączenia do tego badania klinicznego, jeśli spełniony zostanie którykolwiek z poniższych kryteriów:

    1. Ciąża, laktacja. Kobiety w wieku rozrodczym, które nie są w ciąży, ale nie stosują skutecznych metod antykoncepcji.
    2. Uczestnicy badania z zaawansowaną chorobą Parkinsona opisaną jako ciężka niepełnosprawność, przykuci do wózka inwalidzkiego lub przykuci do łóżka.
    3. U uczestnika badania występuje jakikolwiek aktywny nowotwór złośliwy, w tym rak podstawnokomórkowy skóry, rak płaskonabłonkowy lub czerniak skóry.
    4. Uczestnik badania ma znane uzależnienie lub uzależnienie od alkoholu lub obecnie używa lub nadużywa substancji.

    5. Uczestnik badania ma 1 lub więcej istotnych współistniejących schorzeń (potwierdzonych dokumentacją medyczną), w tym:

      • Źle kontrolowana cukrzyca (PCDM) zdefiniowana jako historia niedostatecznego standardowego leczenia i/lub glikemia przedposiłkowa >130mg/dl podczas wizyty przesiewowej lub glikemia poposiłkowa >200mg/dl.
      • Wywiad medyczny dotyczący rozpoznania przewlekłej choroby nerek (CKD) i/lub wyników badań przesiewowych eGFR < 59 ml/min/1,73 m2.
      • Obecność niewydolności serca klasy III/IV według New York Heart Association (NYHA) podczas wizyty przesiewowej.
      • Każda historia medyczna zawału mięśnia sercowego dowolnego typu, takiego jak zawał mięśnia sercowego z uniesieniem odcinka ST (STEMI) lub zawał mięśnia sercowego bez uniesienia odcinka ST (NSTEMI), skurcz wieńcowy lub niestabilna dławica piersiowa.
      • Wywiad chorobowy dotyczący niekontrolowanego nadciśnienia tętniczego definiowanego jako niedostateczny standard leczenia i/lub ciśnienie krwi > 180/120 mm/Hg podczas wizyty przesiewowej.
      • Historia medyczna trombofilii wrodzonych, niedawno przebyta poważna operacja ogólna (w ciągu 12 miesięcy przed badaniem przesiewowym), porażenie kończyn dolnych w wyniku urazu rdzenia kręgowego, złamanie miednicy, biodra lub kości udowej, rak płuca, mózgu, limfatyczny, układ ginekologiczny ( jajnika lub macicy) lub przewodu pokarmowego (jak trzustka lub żołądek).
      • Historia operacji mózgu w chorobie Parkinsona.
    6. Uczestnik badania otrzymał jakiekolwiek leczenie komórkami macierzystymi w ciągu 6 miesięcy przed podaniem pierwszej dawki badanego produktu innego niż komórki macierzyste produkowane przez Hope Biosciences.
    7. Otrzymywanie dowolnej terapii eksperymentalnej lub dowolnej terapii zatwierdzonej do użytku eksperymentalnego w ciągu 1 roku przed pierwszą dawką badanego produktu innej niż szczepionki COVID-19.

    8. Uczestnik badania ma nieprawidłowości laboratoryjne podczas badania przesiewowego, w tym:

      • Liczba białych krwinek < 3000/mm3
      • Liczba płytek krwi < 80 000 mm3
      • Bezwzględna liczba neutrofili < 1500/mm3
      • Aminotransferaza alaninowa (ALT) lub aminotransferaza asparaginianowa (AST) 10 górna granica normy (GGN) x 1,5
    9. U uczestnika badania występują jakiekolwiek inne nieprawidłowości laboratoryjne lub schorzenia, które w opinii badacza stanowią zagrożenie dla bezpieczeństwa lub uniemożliwiają uczestnikowi ukończenie badania.
    10. Jest mało prawdopodobne, aby uczestnik badania ukończył badanie lub przestrzegał procedur badania.
    11. Uczestnik badania ze znanym współistniejącym ostrym lub przewlekłym wirusowym zapaleniem wątroby typu B lub C lub ludzkim wirusem upośledzenia odporności (HIV).
    12. Uczestnik badania ma wcześniej rozpoznaną chorobę psychiczną, która w opinii badacza może wpływać na samoocenę.
    13. Uczestnik badania z jakąkolwiek infekcją ogólnoustrojową wymagającą leczenia antybiotykami, lekami przeciwwirusowymi lub przeciwgrzybiczymi w ciągu 30 dni przed podaniem pierwszej dawki badanego produktu.
    14. Mężczyźni biorący udział w badaniu, którzy planują oddać nasienie w trakcie badania lub w ciągu 6 miesięcy po przyjęciu ostatniej dawki. Pacjentki, które planują oddać komórki jajowe lub poddać się zabiegowi zapłodnienia pozaustrojowego w trakcie badania lub w ciągu 6 miesięcy po przyjęciu ostatniej dawki.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Allogeniczne HB-adMSC.

Biologiczne/Szczepionki: Allogeniczne HB-adMSC

Allogeniczne HB-adMSC zostaną podane dożylnie kwalifikującym się uczestnikom badania.

Inne nazwy: Allogeneic Hope Biosciences mezenchymalne komórki macierzyste pochodzące z tkanki tłuszczowej.
Biologiczny: Biologiczne/Szczepionki: Allogeniczne HB-adMSC
HB-adMSC będą podawane dożylnie kwalifikującym się uczestnikom badania.
Inne nazwy:
  • Allogeneic Hope Biosciences mezenchymalne komórki macierzyste pochodzące z tkanki tłuszczowej.
Inny: Placebo
Sterylny roztwór soli fizjologicznej 0,9%
Inne nazwy:
  • Placebo będzie podawane dożylnie kwalifikującym się uczestnikom badania.
Komparator placebo: Placebo

Placebo będzie podawane dożylnie kwalifikującym się uczestnikom badania.

Inne nazwy: Sterylny roztwór soli fizjologicznej 0,9%
Biologiczny: Biologiczne/Szczepionki: Allogeniczne HB-adMSC
HB-adMSC będą podawane dożylnie kwalifikującym się uczestnikom badania.
Inne nazwy:
  • Allogeneic Hope Biosciences mezenchymalne komórki macierzyste pochodzące z tkanki tłuszczowej.
Inny: Placebo
Sterylny roztwór soli fizjologicznej 0,9%
Inne nazwy:
  • Placebo będzie podawane dożylnie kwalifikującym się uczestnikom badania.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in MDS-UPDRS Part III Total Score
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in MDS-UPDRS Part I Total Score
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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]
Ramy czasowe: 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]
Ramy czasowe: 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]
Ramy czasowe: 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]
Ramy czasowe: 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]
Ramy czasowe: 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]
Ramy czasowe: 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]
Ramy czasowe: 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]
Ramy czasowe: 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]
Ramy czasowe: 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]
Ramy czasowe: 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]
Ramy czasowe: 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]
Ramy czasowe: 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]
Ramy czasowe: 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]
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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 - %)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: Baseline to Weeks 52
Physical examination - by treatment week - Summary - Safety analysis set
Baseline to Weeks 52
Physical Examination - by Treatment Week - Cardiovascular
Ramy czasowe: Baseline to Weeks 52
Physical examination - by treatment week - Summary - Safety analysis set
Baseline to Weeks 52
Physical Examination - by Treatment Week - HEENT
Ramy czasowe: 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
Ramy czasowe: Baseline to Weeks 52
Physical examination - by treatment week - Summary - Safety analysis set
Baseline to Weeks 52
Physical Examination - by Treatment Week - Musculoskeletal
Ramy czasowe: Baseline to Weeks 52
Physical examination - by treatment week - Summary - Safety analysis set
Baseline to Weeks 52
Physical Examination - by Treatment Week - Neurological
Ramy czasowe: Baseline to Weeks 52
Physical examination - by treatment week - Summary - Safety analysis set
Baseline to Weeks 52
Physical Examination - by Treatment Week - Respiratory
Ramy czasowe: Baseline to Weeks 52
Physical examination - by treatment week - Summary - Safety analysis set
Baseline to Weeks 52
Physical Examination - by Treatment Week - Skin
Ramy czasowe: Baseline to Weeks 52
Physical examination - by treatment week - Summary - Safety analysis set
Baseline to Weeks 52

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Hope Biosciences Research Foundation

Współpracownicy

Hope Biosciences

Śledczy

  • Główny śledczy: Djamchid Lotfi, MD, Hope Biosciences Stem Cell Research Foundation

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

16 lipca 2021

Zakończenie podstawowe (Rzeczywisty)

3 października 2025

Ukończenie studiów (Rzeczywisty)

3 października 2025

Daty rejestracji na studia

Pierwszy przesłany

16 lipca 2021

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 sierpnia 2021

Pierwszy wysłany (Rzeczywisty)

6 sierpnia 2021

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

10 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

14 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • HBPD04

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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