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Parkinsonin taudin kliininen tutkimus, jossa käytetään allogeenisiä HB-adMSC:itä (varhainen ja keskivaikea PD)

torstai 14. toukokuuta 2026 päivittänyt: Hope Biosciences Research Foundation

Satunnaistettu, kaksoissokkoutettu, yksi keskus, vaihe 2, teho- ja turvallisuustutkimus allogeenisista HB-adMSC:istä vs. lumelääke Parkinsonin tautia sairastavien potilaiden hoitoon

Tämä on satunnaistettu, kaksoissokkoutettu, yhden keskuksen, vaiheen 2 tutkimus, jossa arvioidaan useiden allogeenisten HB-adMSC:iden tehoa ja turvallisuutta verrattuna lumelääkkeeseen Parkinsonin taudin hoidossa.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

Tutkimus sisältää enintään 4 viikkoa kestävän seulontajakson, 32 viikon hoitojakson ja 20 viikon turvallisuuden seurantajakson viimeisen tutkimustuotteen annon jälkeen.

Tämä kliininen tutkimus on avoin 60 osallistujalle, joilla on diagnosoitu Parkinsonin tauti. Potilaiden rekrytoinnin suorittaa tutkimusryhmä, jos kelpoisuuskriteerien perusteella tunnistetaan kelvollisia osallistujia, järjestetään seulontakäynti. Tietoinen suostumuslomake annetaan tutkimukseen osallistuneille ja allekirjoitetaan ennen tutkimustoimenpiteitä. Tietoinen suostumuslomake sisältää tiedot kliinisestä tutkimuksesta, ja joitain näkökohtia tulee ottaa huomioon tämän prosessin aikana.

Kun tietoinen suostumus on saatu, jokaisen osallistujan tulee suorittaa seuraavat käynnit.

  • Vierailu 1 – Seulonta Tämän käynnin aikana päätutkija tekee päätöksen määrittääkseen, onko seulottu osallistuja kelvollinen ja voidaanko seuraava käynti ajoittaa. Kun päätutkija on arvioinut seulotun kohteen kelpoisuuden (enintään 28 päivää), suoritetaan satunnaistamisprosessi, jotta soveltuva kohde määritetään joko allogeenisten HB-adMSC:iden tai lumelääkevalmisteen avulla. Satunnaistaminen koskee vain kelvollisia aiheita. Jos tutkimukseen osallistuja ei täytä seulontaprosessin aikana sisällyttämis- ja poissulkemiskriteerejä, hänet katsotaan Screen Failure (SF) -seulonnaksi, eikä satunnaistamista vaadita.
  • Vierailu 2 - Infuusio 1, (perustila): tätä käyntiä käytetään lähtökohtana osallistujien tietojen vertailulle. Tämän vierailun aikana kelvolliset tutkimukseen osallistujat saavat ensimmäisen tutkimustuotteensa tai lumelääkkeensä ja elintoimintojen seurantaa yhteensä 2 tunnin ajan lääkkeelle altistumisen jälkeen. Muut tutkimusarvioinnit valmistuvat osana tätä vierailua.
  • Käynti 3 - Infuusio 2: noin 4 viikkoa ensimmäisen tutkimustuotteen annon jälkeen tämän käynnin tulee olla valmis. Muut tutkimusarvioinnit valmistuvat osana tätä vierailua.
  • Käynti 4 - Infuusio 3: noin 8 viikkoa ensimmäisen tutkimustuotteen annon jälkeen tämän käynnin tulee olla valmis. Muut tutkimusarvioinnit valmistuvat osana tätä vierailua.
  • Käynti 5 - Infuusio 4: noin 12 viikkoa ensimmäisen tutkimustuotteen annon jälkeen tämän käynnin tulee olla valmis. Muut tutkimusarvioinnit valmistuvat osana tätä vierailua.
  • Käynti 6 - Infuusio 5: noin 16 viikkoa ensimmäisen tutkimustuotteen annon jälkeen tämän käynnin tulee olla valmis. Muut tutkimusarvioinnit valmistuvat osana tätä vierailua.
  • Käynti 7 - Infuusio 6: noin 20 viikkoa ensimmäisen tutkimustuotteen annon jälkeen tämän käynnin tulee olla valmis. Muut tutkimusarvioinnit valmistuvat osana tätä vierailua.
  • Puhelinsoitto - Turvallisuusseuranta: noin 24 viikkoa ensimmäisen tutkimustuotteen antamisen jälkeen aktiiviset tutkimuksen osallistujat suorittavat puhelinsoiton seurannan.
  • Puhelinsoitto - Turvallisuusseuranta: noin 32 viikkoa ensimmäisen tutkimustuotteen antamisen jälkeen aktiiviset tutkimuksen osallistujat suorittavat puhelinsoiton seurannan.
  • Vierailu 8 – Tutkimuksen loppu Tämän viimeisen käynnin aikana (noin 52 viikkoa viikon 0 jälkeen) suoritetaan täydellinen ryhmä tutkimusarviointeja allogeenisten HB-adMSC:iden tai lumelääkkeen antamisen turvallisuuden ja tehokkuuden arvioimiseksi.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

60

Vaihe

  • Vaihe 2

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

45 vuotta - 80 vuotta (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

Sisällyttämiskriteerit:

  • Tutkimukseen osallistuja voidaan ottaa mukaan tähän tutkimukseen vain, jos kaikki seuraavat kriteerit täyttyvät:

    1. Osallistujat miehiä ja naisia ​​45-80v.
    2. Seulontakäynnillä tutkimukseen osallistuneiden MDS-UPDRS osan II pistemäärän tulee olla välillä 7–28.
    3. Tutkimukseen osallistuvien MDS-UPDRS osan III pistemäärän tulee olla 20–57 seulontakäynnin aikana.
    4. Carbidopa/Levodopa-kokonaisannoksen on oltava alle 1200 mg päivässä tutkimukseen osallistuneille.
    5. Tutkimukseen osallistuvien levodopa-ekvivalenttiannoksen on oltava alle 1400 mg päivässä.
    6. Tutkimukseen osallistuvalla henkilöllä on oltava varhainen ja/tai kohtalainen Parkinsonin tauti diagnosoitu vähintään 2 vuotta ennen tutkimukseen osallistumista.
    7. Tutkimukseen osallistuvien tulee pystyä lukemaan, ymmärtämään ja antamaan kirjallinen suostumus.
    8. Vapaaehtoisesti allekirjoitettu tietoinen suostumus, joka on saatu ennen kliinisiin tutkimuksiin liittyvien toimenpiteiden suorittamista.
    9. Naispuoliset tutkimukseen osallistujat eivät saa olla raskaana tai suunnitella raskautta tutkimukseen osallistumisen aikana ja 6 kuukauden ajan viimeisen tutkimustuotteen antamisen jälkeen.
    10. Miespuolisten osallistujien, jos heidän seksuaalikumppaninsa voivat tulla raskaaksi, tulee käyttää ehkäisymenetelmää tutkimukseen osallistumisen aikana ja 6 kuukauden ajan viimeisen tutkitun tuotteen annon jälkeen.
    11. Tutkimukseen osallistuja pystyy ja haluaa noudattaa tämän kliinisen tutkimuksen vaatimuksia.

Poissulkemiskriteerit:

  • Tutkimukseen osallistujaa ei voida ottaa mukaan tähän kliiniseen tutkimukseen, jos jokin seuraavista kriteereistä täyttyy:

    1. Raskaus, imetys. Hedelmällisessä iässä olevat naiset, jotka eivät ole raskaana, mutta eivät käytä tehokasta ehkäisyä.
    2. Tutkimukseen osallistujat, joilla oli pitkälle edennyt Parkinsonin tauti, kuvailtiin vakavaksi vammaiseksi, pyörätuoliin sidottuiksi tai vuodepotilaiksi.
    3. Tutkimukseen osallistuneella on jokin aktiivinen pahanlaatuinen kasvain, mukaan lukien näyttöä ihon tyvisolukarsinoomasta, levyepiteelisyövästä tai melanoomasta.
    4. Tutkimukseen osallistujalla on tiedossa alkoholiriippuvuus tai -riippuvuus tai hänellä on parhaillaan päihteiden käyttöä tai väärinkäyttöä.

    5. Tutkimukseen osallistuvalla on yksi tai useampi merkittävä samanaikainen sairaus (varmistettu lääketieteellisillä tiedoilla), mukaan lukien seuraavat:

      • Huonosti hallinnassa oleva diabetes mellitus (PCDM), joka määritellään anamneesissa puutteelliseksi hoitotasoksi ja/tai aterian glukoosi > 130 mg/dl seulontakäynnin aikana tai aterian jälkeinen glukoosi > 200 mg/dl.
      • Kroonisen munuaissairauden (CKD) diagnoosi ja/tai seulontatulokset eGFR < 59mL/min/1,73m2.
      • New York Heart Associationin (NYHA) luokan III/IV sydämen vajaatoiminta seulontakäynnin aikana.
      • Mikä tahansa sydäninfarkti anamneesissa missä tahansa eri tyypissä, kuten ST-kohonnut sydäninfarkti (STEMI) tai sydäninfarkti ilman ST-kohotusta (NSTEMI), sepelvaltimon kouristus tai epästabiili angina pectoris.
      • Anamneesissa hallitsematon korkea verenpaine, joka määritellään puutteelliseksi hoitotasoksi ja/tai verenpaine > 180/120 mm/Hg seulontakäynnin aikana.
      • Anamneesissa perinnöllinen trombofilia, äskettäin suuri yleisleikkaus, (12 kuukauden sisällä ennen seulontaa), alaraajojen halvaantuminen selkäydinvauriosta, lantion, lonkan tai reisiluun murtuma, keuhko-, aivo-, imusolmukkeiden, gynekologisen järjestelmän syöpä ( munasarja tai kohtu) tai maha-suolikanava (kuten haima tai vatsa).
      • Parkinsonin taudin aivoleikkauksen historia.
    6. Tutkimukseen osallistuja on saanut mitä tahansa kantasoluhoitoa 6 kuukauden sisällä ennen ensimmäistä annosta muuta tutkimusvalmistetta kuin Hope Biosciencesin tuottamia kantasoluja.
    7. Mikä tahansa tutkimushoito tai tutkimuskäyttöön hyväksytty hoito 1 vuoden sisällä ennen ensimmäistä tutkimustuotteen annosta, paitsi COVID-19-rokotteita.

    8. Tutkimukseen osallistujalla on laboratoriopoikkeavuus seulonnan aikana, mukaan lukien seuraavat:

      • Valkosolujen määrä < 3000/mm3
      • Verihiutalemäärä < 80 000 mm3
      • Absoluuttinen neutrofiilien määrä < 1500/mm3
      • Alaniiniaminotransferaasi (ALT) tai aspartaattiaminotransferaasi (AST) 10 normaalin yläraja (ULN) x 1,5
    9. Tutkimukseen osallistuvalla on jokin muu laboratoriopoikkeavuus tai sairaus, joka tutkijan näkemyksen mukaan aiheuttaa turvallisuusriskin tai estää tutkittavaa suorittamasta tutkimusta loppuun.
    10. Tutkimukseen osallistuja ei todennäköisesti saa tutkimusta loppuun tai noudattaa tutkimusmenetelmiä.
    11. Tutkimukseen osallistuja, jolla on samanaikainen akuutti tai krooninen hepatiitti B- tai C- tai ihmisen immuunikatovirus (HIV) -infektio.
    12. Tutkimukseen osallistuvalla on aiemmin diagnosoitu psykiatrinen sairaus, joka voi tutkijan näkemyksen mukaan vaikuttaa itsearviointiin.
    13. Tutkimukseen osallistuja, jolla on mikä tahansa systeeminen infektio, joka vaatii hoitoa antibiooteilla, viruslääkkeillä tai sienilääkkeillä 30 päivän sisällä ennen tutkimustuotteen ensimmäistä annosta.
    14. Miespuoliset tutkimuksen osallistujat, jotka aikovat luovuttaa siittiöitä tutkimuksen aikana tai 6 kuukauden sisällä viimeisestä annoksesta. Naispotilaat, jotka suunnittelevat luovuttavansa munasoluja tai joutuvat koeputkihedelmöityshoitoon tutkimuksen aikana tai 6 kuukauden sisällä viimeisestä annoksesta.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Nelinkertaistaa

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Active Comparator: Allogeeniset HB-adMSC:t.

Biologinen/rokote: Allogeeniset HB-adMSC:t

Allogeenisiä HB-adMSC:itä annetaan suonensisäisesti päteville tutkimuksen osallistujille.

Muut nimet: Allogeneic Hope Biosciences rasvaperäiset mesenkymaaliset kantasolut.
Biologinen: Biologinen/rokote: Allogeeniset HB-adMSC:t
HB-adMSC:t annetaan suonensisäisesti päteville tutkimuksen osallistujille.
Muut nimet:
  • Allogeneic Hope Biosciences tuottaa rasvaperäisiä mesenkymaalisia kantasoluja.
Muut: Plasebo
Steriili suolaliuos 0,9 %
Muut nimet:
  • Plaseboa annetaan suonensisäisesti päteville tutkimuksen osallistujille.
Placebo Comparator: Plasebo

Plaseboa annetaan suonensisäisesti päteville tutkimuksen osallistujille.

Muut nimet: Steriili suolaliuos 0,9 %
Biologinen: Biologinen/rokote: Allogeeniset HB-adMSC:t
HB-adMSC:t annetaan suonensisäisesti päteville tutkimuksen osallistujille.
Muut nimet:
  • Allogeneic Hope Biosciences tuottaa rasvaperäisiä mesenkymaalisia kantasoluja.
Muut: Plasebo
Steriili suolaliuos 0,9 %
Muut nimet:
  • Plaseboa annetaan suonensisäisesti päteville tutkimuksen osallistujille.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change From Baseline in MDS-UPDRS Part III Total Score
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change From Baseline in MDS-UPDRS Part I Total Score
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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]
Aikaikkuna: 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]
Aikaikkuna: 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]
Aikaikkuna: 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]
Aikaikkuna: 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]
Aikaikkuna: 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]
Aikaikkuna: 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]
Aikaikkuna: 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]
Aikaikkuna: 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]
Aikaikkuna: 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]
Aikaikkuna: 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]
Aikaikkuna: 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]
Aikaikkuna: 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]
Aikaikkuna: 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]
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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 - %)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: Baseline to Weeks 52
Physical examination - by treatment week - Summary - Safety analysis set
Baseline to Weeks 52
Physical Examination - by Treatment Week - Cardiovascular
Aikaikkuna: Baseline to Weeks 52
Physical examination - by treatment week - Summary - Safety analysis set
Baseline to Weeks 52
Physical Examination - by Treatment Week - HEENT
Aikaikkuna: 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
Aikaikkuna: Baseline to Weeks 52
Physical examination - by treatment week - Summary - Safety analysis set
Baseline to Weeks 52
Physical Examination - by Treatment Week - Musculoskeletal
Aikaikkuna: Baseline to Weeks 52
Physical examination - by treatment week - Summary - Safety analysis set
Baseline to Weeks 52
Physical Examination - by Treatment Week - Neurological
Aikaikkuna: Baseline to Weeks 52
Physical examination - by treatment week - Summary - Safety analysis set
Baseline to Weeks 52
Physical Examination - by Treatment Week - Respiratory
Aikaikkuna: Baseline to Weeks 52
Physical examination - by treatment week - Summary - Safety analysis set
Baseline to Weeks 52
Physical Examination - by Treatment Week - Skin
Aikaikkuna: Baseline to Weeks 52
Physical examination - by treatment week - Summary - Safety analysis set
Baseline to Weeks 52

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Hope Biosciences Research Foundation

Yhteistyökumppanit

Hope Biosciences

Tutkijat

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

Julkaisuja ja hyödyllisiä linkkejä

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Opintojen ennätyspäivät

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Ensimmäinen lähetetty

Perjantai 16. heinäkuuta 2021

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Maanantai 2. elokuuta 2021

Ensimmäinen Lähetetty (Todellinen)

Perjantai 6. elokuuta 2021

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Keskiviikko 10. kesäkuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Torstai 14. toukokuuta 2026

Viimeksi vahvistettu

Perjantai 1. toukokuuta 2026

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Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • HBPD04

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