Клинические испытания болезни Паркинсона с использованием аллогенных HB-adMSC (ранняя и умеренная БП)
Рандомизированное двойное слепое одноцентровое исследование фазы 2 эффективности и безопасности аллогенных HB-adMSC по сравнению с плацебо для лечения пациентов с болезнью Паркинсона
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Испытание включает период скрининга продолжительностью до 4 недель, период лечения 32 недели и период наблюдения за безопасностью в течение 20 недель после последнего введения исследуемого продукта.
Это клиническое испытание будет открыто для включения 60 подходящих участников с диагнозом болезнь Паркинсона. Набор пациентов будет проводиться исследовательской группой, если подходящие участники будут определены на основе критериев приемлемости, будет запланирован визит для скрининга. Форма информированного согласия будет предоставлена участникам исследования и подписана перед любыми процедурами исследования. Форма информированного согласия будет включать информацию о клиническом испытании, и в ходе этого процесса следует учитывать некоторые аспекты.
После получения информированного согласия каждый участник должен пройти следующие визиты.
- Визит 1 — скрининг, во время этого визита главный исследователь примет решение, чтобы определить, подходит ли прошедший скрининг участник и можно ли запланировать следующий визит. После того, как главный исследователь оценил пригодность обследуемого субъекта (до 28 дней), будет проведен процесс рандомизации, чтобы назначить подходящему субъекту либо аллогенные HB-adMSC, либо плацебо. Рандомизация будет применяться только к подходящим субъектам. Если участник исследования не соответствует критериям включения и исключения в процессе скрининга, он/она будет считаться неудачником скрининга (SF), и рандомизация не требуется.
- Визит 2 - инфузия 1 (исходный уровень): этот визит будет использоваться в качестве отправной точки для сравнения данных участников. Во время этого визита подходящие участники исследования получат свое первое введение исследуемого продукта или плацебо с мониторингом показателей жизнедеятельности в общей сложности в течение 2 часов после воздействия препарата. Другие оценки исследований будут завершены в рамках этого визита.
- Визит 3 - Инфузия 2: примерно через 4 недели после первоначального введения исследуемого продукта этот визит должен быть завершен. Другие оценки исследований будут завершены в рамках этого визита.
- Визит 4 - Инфузия 3: примерно через 8 недель после первоначального введения исследуемого препарата этот визит следует завершить. Другие оценки исследований будут завершены в рамках этого визита.
- Визит 5 - Инфузия 4: примерно через 12 недель после первоначального введения исследуемого продукта этот визит должен быть завершен. Другие оценки исследований будут завершены в рамках этого визита.
- Визит 6 - Инфузия 5: примерно через 16 недель после первоначального введения исследуемого продукта этот визит должен быть завершен. Другие оценки исследований будут завершены в рамках этого визита.
- Визит 7 - Инфузия 6: примерно через 20 недель после первоначального введения исследуемого продукта этот визит должен быть завершен. Другие оценки исследований будут завершены в рамках этого визита.
- Телефонный звонок — контроль безопасности: примерно через 24 недели после первоначального введения исследуемого продукта активные участники исследования завершат контрольный телефонный звонок.
- Телефонный звонок – контроль безопасности: примерно через 32 недели после первоначального введения исследуемого продукта активные участники исследования завершат контрольный телефонный звонок.
- Визит 8 - конец исследования, во время этого последнего визита (приблизительно через 52 недели после недели 0) будет проведена полная группа оценок исследования для оценки безопасности и эффективности введения аллогенных HB-adMSC или плацебо.
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 2
Контакты и местонахождение
Места учебы
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Texas
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Sugar Land, Texas, Соединенные Штаты, 77478
- Hope Biosciences Stem Cell Research Foundation
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Описание
Критерии включения:
Участник исследования будет иметь право на включение в это исследование, только если выполняются все следующие критерии:
- Участники мужского и женского пола от 45 до 80 лет.
- Во время скринингового визита участники исследования должны иметь балл MDS-UPDRS, часть II, от 7 до 28.
- Участники исследования должны иметь балл MDS-UPDRS, часть III, от 20 до 57 во время скринингового визита.
- Общая доза карбидопы/леводопы для участников исследования должна быть менее 1200 мг в день.
- Общая эквивалентная доза леводопы для участников исследования должна быть менее 1400 мг в сутки.
- У участника исследования должна быть диагностирована болезнь Паркинсона ранней и/или средней степени тяжести не менее чем за 2 года до участия в исследовании.
- Участники исследования должны уметь читать, понимать и давать письменное согласие.
- Добровольно подписанное информированное согласие, полученное до выполнения любых процедур, связанных с клиническими испытаниями.
- Женщины-участницы исследования не должны быть беременны или планировать беременность во время участия в исследовании и в течение 6 месяцев после последнего приема исследуемого продукта.
- Участники мужского пола, если их половые партнеры могут забеременеть, должны использовать метод контрацепции во время участия в исследовании и в течение 6 месяцев после последнего введения исследуемого продукта.
- Участник исследования может и желает соблюдать требования данного клинического исследования.
Критерий исключения:
Участник исследования не будет иметь права на включение в это клиническое исследование, если применим любой из следующих критериев:
- Беременность, лактация. Женщины детородного возраста, не беременные, но не применяющие эффективные меры контрацепции.
- Участники исследования с прогрессирующей болезнью Паркинсона, описываемой как тяжелая инвалидность, прикованы к инвалидной коляске или прикованы к постели.
- У участника исследования есть какое-либо активное злокачественное новообразование, включая признаки кожной базальной, плоскоклеточной карциномы или меланомы.
- Участник исследования знал об алкогольной зависимости или зависимости или в настоящее время употребляет или злоупотребляет психоактивными веществами.
Участник исследования имеет 1 или более серьезных сопутствующих заболеваний (подтвержденных медицинскими записями), в том числе следующие:
- Плохо контролируемый сахарный диабет (PCDM), определяемый как неадекватное стандартное лечение в анамнезе и/или уровень глюкозы до приема пищи > 130 мг/дл во время скринингового визита или уровень глюкозы после приема пищи > 200 мг/дл.
- Медицинский анамнез диагноза хронической болезни почек (ХБП) и/или результаты скрининга рСКФ < 59 мл/мин/1,73 м2.
- Наличие сердечной недостаточности III/IV класса Нью-Йоркской кардиологической ассоциации (NYHA) во время скринингового визита.
- Любая история инфаркта миокарда любого из различных типов, например, инфаркт миокарда с подъемом сегмента ST (ИМпST) или инфаркт миокарда без подъема сегмента ST (NSTEMI), коронарный спазм или нестабильная стенокардия.
- Медицинский анамнез неконтролируемого высокого кровяного давления, определяемого как недостаточное стандартное лечение и / или артериальное давление> 180/120 мм рт.ст. во время скринингового визита.
- В анамнезе наследственные тромбофилии, недавние обширные общие операции (в течение 12 месяцев до скрининга), паралич нижних конечностей из-за травмы спинного мозга, перелом таза, бедра или бедренной кости, рак легкого, головного мозга, лимфатической, гинекологической системы ( яичник или матка) или желудочно-кишечный тракт (например, поджелудочная железа или желудок).
- История хирургии головного мозга при болезни Паркинсона.
- Участник исследования получал какое-либо лечение стволовыми клетками в течение 6 месяцев до первой дозы исследуемого продукта, кроме стволовых клеток, произведенных Hope Biosciences.
- Получать любую исследуемую терапию или любую одобренную терапию для исследовательского использования в течение 1 года до первой дозы исследуемого продукта, кроме вакцин против COVID-19.
У участника исследования обнаружены лабораторные отклонения во время скрининга, в том числе следующие:
- Количество лейкоцитов < 3000/мм3
- Количество тромбоцитов < 80 000 мм3
- Абсолютное количество нейтрофилов < 1500/мм3
- Аланинаминотрансфераза (АЛТ) или аспартатаминотрансфераза (АСТ) 10 верхняя граница нормы (ВГН) x 1,5
- У участника исследования есть какие-либо другие лабораторные отклонения или заболевания, которые, по мнению исследователя, представляют угрозу безопасности или не позволяют субъекту завершить исследование.
- Участник исследования вряд ли завершит исследование или будет придерживаться процедур исследования.
- Участник исследования с известным сопутствующим острым или хроническим вирусным гепатитом B или C или вирусом иммунодефицита человека (ВИЧ).
- Участник исследования имеет ранее диагностированное психическое заболевание, которое, по мнению исследователя, может повлиять на самооценку.
- Участник исследования с любой системной инфекцией, требующей лечения антибиотиками, противовирусными или противогрибковыми препаратами в течение 30 дней до первой дозы исследуемого продукта.
- Участники исследования мужского пола, планирующие сдать сперму во время исследования или в течение 6 месяцев после последней дозы. Пациенты женского пола, которые планируют стать донорами яйцеклеток или пройти процедуру экстракорпорального оплодотворения во время исследования или в течение 6 месяцев после последней дозы.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Активный компаратор: Аллогенные HB-adMSC.
Биологические/Вакцины: Аллогенные HB-adMSC Аллогенные HB-adMSC будут вводиться внутривенно участникам исследования, соответствующим требованиям. Другие названия: мезенхимальные стволовые клетки, полученные из жировой ткани Allogeneic Hope Biosciences. |
HB-adMSC будут вводиться внутривенно участникам исследования, соответствующим требованиям.
Другие имена:
Стерильный физиологический раствор 0,9%
Другие имена:
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Плацебо Компаратор: Плацебо
Участникам исследования, соответствующим требованиям, будет вводиться плацебо внутривенно. Другие названия: стерильный солевой раствор 0,9% |
HB-adMSC будут вводиться внутривенно участникам исследования, соответствующим требованиям.
Другие имена:
Стерильный физиологический раствор 0,9%
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change From Baseline in MDS-UPDRS Part III Total Score
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change From Baseline in MDS-UPDRS Part I Total Score
Временное ограничение: 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
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Change From Baseline in MDS-UPDRS Part I (Statistical Analysis - RMA Model)
Временное ограничение: Baseline to Weeks 52
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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
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Change From Baseline in MDS-UPDRS Part I (Bayesian Statistical Analysis - RMA Model)
Временное ограничение: Baseline to Weeks 52
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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
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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
Временное ограничение: Baseline to Weeks 52
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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
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Change From Baseline in MDS-UPDRS Part IV Total Score
Временное ограничение: Baseline to Weeks 52
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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.
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Baseline to Weeks 52
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Change From Baseline in MDS-UPDRS Part IV Total Score (Statistical Analysis - RMA Model)
Временное ограничение: 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.
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Baseline to Weeks 52
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Change From Baseline in MDS-UPDRS Part IV Total Score (Bayesian Statistical Analysis - RMA Model)
Временное ограничение: 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.
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Baseline to Weeks 52
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Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part IV Score - by Treatment Week
Временное ограничение: 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.
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Baseline to Weeks 52
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Change From Baseline in SF-36 (Average General Health) Total Score
Временное ограничение: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Physical Functioning) Total Score
Временное ограничение: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score
Временное ограничение: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Social Functioning) Total Score
Временное ограничение: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score
Временное ограничение: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score
Временное ограничение: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health) Total Score
Временное ограничение: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score
Временное ограничение: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average General Health) Total Score (Statistical Analysis - RMA Model)
Временное ограничение: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Statistical Analysis - RMA Model)
Временное ограничение: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Statistical Analysis - RMA Model)
Временное ограничение: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Social Functioning) Total Score (Statistical Analysis - RMA Model)
Временное ограничение: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Statistical Analysis - RMA Model)
Временное ограничение: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Statistical Analysis - RMA Model)
Временное ограничение: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health ) Total Score (Statistical Analysis - RMA Model)
Временное ограничение: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score (Statistical Analysis - RMA Model)
Временное ограничение: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average General Health) Total Score (Bayesian Statistical Analysis - RMA Model)
Временное ограничение: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Bayesian Statistical Analysis - RMA Model)
Временное ограничение: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Bayesian Statistical Analysis - RMA Model)
Временное ограничение: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Social Functioning) Total Score (Bayesian Statistical Analysis - RMA Model)
Временное ограничение: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Bayesian Statistical Analysis - RMA Model)
Временное ограничение: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Bayesian Statistical Analysis - RMA Model)
Временное ограничение: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Role Limitations Due To Physical Health) Total Score (Bayesian Statistical Analysis - RMA Model)
Временное ограничение: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Role Limitations Due To Emotional Problems) Total Score (Bayesian Statistical Analysis - RMA Model)
Временное ограничение: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Raw Scores
Временное ограничение: Baseline to Weeks 52
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The Parkinson's Disease Fatigue Scale (PFS-16) is a patient-rated scale that measures fatigue in Parkinson's patients.
It has 7 items on the measurement of presence of fatigue and 9 items on its impact on daily function.
It can be used to assess levels of fatigue and measure any changes that treatment or lifestyle changes may affect.
There are five answer choices for each item: Strongly disagree (1 point), Disagree (2 points), Do not agree or disagree (3 points), Agree (4 points), and Strongly agree (5 points).
The PFS-16 score ranges from 16 (minimum) to 80 (maximum).
Higher scores represent a worse outcome.
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Baseline to Weeks 52
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Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Statistical Analysis - RMA Model)
Временное ограничение: Baseline to Weeks 52
|
Clinically significant changes in PFS-16 scores.
The Parkinson's Disease Fatigue Scale (PFS-16) is a patient-rated scale that measures fatigue in Parkinson's patients.
It has 7 items on the measurement of presence of fatigue and 9 items on its impact on daily function.
It can be used to assess levels of fatigue and measure any changes that treatment or lifestyle changes may affect.
There are five answer choices for each item: Strongly disagree (1 point), Disagree (2 points), Do not agree or disagree (3 points), Agree (4 points), and Strongly agree (5 points).
The PFS-16 score ranges from 16 (minimum) to 80 (maximum).
Higher scores represent a worse outcome.
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Baseline to Weeks 52
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Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Bayesian Statistical Analysis - RMA Model)
Временное ограничение: Baseline to Weeks 52
|
Clinically significant changes in PFS-16 scores.
The Parkinson's Disease Fatigue Scale (PFS-16) is a patient-rated scale that measures fatigue in Parkinson's patients.
It has 7 items on the measurement of presence of fatigue and 9 items on its impact on daily function.
It can be used to assess levels of fatigue and measure any changes that treatment or lifestyle changes may affect.
There are five answer choices for each item: Strongly disagree (1 point), Disagree (2 points), Do not agree or disagree (3 points), Agree (4 points), and Strongly agree (5 points).
The PFS-16 score ranges from 16 (minimum) to 80 (maximum).
Higher scores represent a worse outcome.
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Baseline to Weeks 52
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Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores
Временное ограничение: Baseline to Weeks 52
|
Clinically significant changes in PDQ-39 SI raw scores.
The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month.
The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being.
Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always).
The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100).
To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100).
Higher scores represent a worse outcome.
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Baseline to Weeks 52
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Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Statistical Analysis - RMA Model)
Временное ограничение: Baseline to Weeks 52
|
Clinically significant changes in PDQ-39 SI raw scores.
The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month.
The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being.
Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always).
The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100).
To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100).
Higher scores represent a worse outcome.
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Baseline to Weeks 52
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Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Bayesian Statistical Analysis - RMA Model)
Временное ограничение: Baseline to Weeks 52
|
Clinically significant changes in PDQ-39 SI raw scores.
The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month.
The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being.
Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always).
The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100).
To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100).
Higher scores represent a worse outcome.
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Baseline to Weeks 52
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Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores - by Treatment Week
Временное ограничение: 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
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Change From Baseline in Visual Analog Scale (VAS) Pain Raw Scores
Временное ограничение: Baseline to Weeks 52
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Clinically significant changes in VAS Pain raw scores.
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" used to measure intensity in pain and various other areas.
The patient marks a point on the line corresponding to their pain intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm.
Higher scores represent worse outcomes.
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Baseline to Weeks 52
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Change From Baseline in Visual Analog Scale (VAS) Pain Scores (Statistical Analysis - RMA Model)
Временное ограничение: Baseline to Weeks 52
|
Clinically significant changes in VAS Pain raw scores.
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" used to measure intensity in pain and various other areas.
The patient marks a point on the line corresponding to their pain intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm.
Higher scores represent worse outcomes.
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Baseline to Weeks 52
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Change From Baseline in Visual Analog Scale (VAS) Pain Scores (Bayesian Statistical Analysis - RMA Model)
Временное ограничение: Baseline to Weeks 52
|
Clinically significant changes in VAS Pain raw scores.
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" used to measure intensity in pain and various other areas.
The patient marks a point on the line corresponding to their pain intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm.
Higher scores represent worse outcomes.
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Baseline to Weeks 52
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Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Raw Scores
Временное ограничение: Baseline to Weeks 52
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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.
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Baseline to Weeks 52
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Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Scores (Statistical Analysis - RMA Model)
Временное ограничение: Baseline to Weeks 52
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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.
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Baseline to Weeks 52
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Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Scores (Bayesian Statistical Analysis - RMA Model)
Временное ограничение: Baseline to Weeks 52
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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.
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Baseline to Weeks 52
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Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total VAS Scores - by Treatment Week
Временное ограничение: Baseline to Weeks 52
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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.
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Baseline to Weeks 52
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Summary of PD Medication Dose Changes by Visit
Временное ограничение: Baseline to Weeks 52
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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.
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Baseline to Weeks 52
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Summary of PD Medication Reinstatement by Visit
Временное ограничение: Baseline to Weeks 52
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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.
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Baseline to Weeks 52
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Treatment Emergent Adverse Events (Subjects With >= 1 Adverse Event) - Summary - Safety Analysis Set
Временное ограничение: Baseline to Week 24
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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).
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Baseline to Week 24
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Treatment Emergent Adverse Events (Serious AEs) - Summary - Safety Analysis Set
Временное ограничение: Baseline to Week 24
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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).
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Baseline to Week 24
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Change From Baseline Laboratory Values - CBC (x10^9 Cells/L) [Time Frame: Baseline to Week 52]
Временное ограничение: Baseline to Weeks 52
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Unit (x10^9 cells/L) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
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Baseline to Weeks 52
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Change From Baseline Laboratory Values - CBC (%) [Time Frame: Baseline to Week 52]
Временное ограничение: Baseline to Weeks 52
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Unit (%) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
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Baseline to Weeks 52
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Change From Baseline Laboratory Values - CBC (g/dL) [Time Frame: Baseline to Week 52]
Временное ограничение: Baseline to Weeks 52
|
Unit (g/dL) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
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Baseline to Weeks 52
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Change From Baseline Laboratory Values - CBC (pg) [Time Frame: Baseline to Week 52]
Временное ограничение: Baseline to Weeks 52
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Unit (pg) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
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Baseline to Weeks 52
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Change From Baseline Laboratory Values - CBC (fL) [Time Frame: Baseline to Week 52]
Временное ограничение: Baseline to Weeks 52
|
Unit (fL) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
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Baseline to Weeks 52
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Change From Baseline Laboratory Values - CBC (10^12/L) [Time Frame: Baseline to Week 52]
Временное ограничение: 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
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Baseline to Weeks 52
|
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Change From Baseline Laboratory Values - CMP (g/dL) [Time Frame: Baseline to Week 52]
Временное ограничение: Baseline to Weeks 52
|
Unit (g/dL) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
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Baseline to Weeks 52
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Change From Baseline Laboratory Values - CMP (Ratio) [Time Frame: Baseline to Week 52]
Временное ограничение: Baseline to Weeks 52
|
Unit (Ratio) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
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Baseline to Weeks 52
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Change From Baseline Laboratory Values - CMP (IU/L) [Time Frame: Baseline to Week 52]
Временное ограничение: Baseline to Weeks 52
|
Unit (IU/L) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
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Baseline to Weeks 52
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Change From Baseline Laboratory Values - CMP (mg/dL) [Time Frame: Baseline to Week 52]
Временное ограничение: Baseline to Weeks 52
|
Unit (mg/dL) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
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Baseline to Weeks 52
|
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Change From Baseline Laboratory Values - CMP (mmol/L) [Time Frame: Baseline to Week 52]
Временное ограничение: Baseline to Weeks 52
|
Unit (mmol/L) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
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Baseline to Weeks 52
|
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Change From Baseline Laboratory Values - CMP (mL/Min/1.73 m^2) [Time Frame: Baseline to Week 52]
Временное ограничение: 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
|
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Change From Baseline Laboratory Values - Coagulation Panel (Ratio) [Time Frame: Baseline to Week 52]
Временное ограничение: Baseline to Weeks 52
|
Unit (Ratio) - Change From Baseline Clinical Laboratory Coagulation Panel by Treatment Week - Descriptive Statistics - Safety Analysis Set
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Baseline to Weeks 52
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Change From Baseline Laboratory Values - Coagulation Panel (Sec.) [Time Frame: Baseline to Week 52]
Временное ограничение: Baseline to Weeks 52
|
Unit (sec.) - Change From Baseline Clinical Laboratory Coagulation Panel by Treatment Week - Descriptive Statistics - Safety Analysis Set
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Baseline to Weeks 52
|
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Change From Baseline in Vital Signs (Diastolic Blood Pressure - mmHg)
Временное ограничение: Baseline to Weeks 52
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Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
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Baseline to Weeks 52
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Change From Baseline in Vital Signs (Heart Rate - Beats/Min)
Временное ограничение: Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
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Baseline to Weeks 52
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Change From Baseline in Vital Signs (Oxygen Saturation - %)
Временное ограничение: Baseline to Weeks 52
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Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
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Baseline to Weeks 52
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Change From Baseline in Vital Signs (Respiration Rate - Breaths/Min)
Временное ограничение: Baseline to Weeks 52
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Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
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Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure - mmHg)
Временное ограничение: Baseline to Weeks 52
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Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
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Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Temperature - Celsius)
Временное ограничение: 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)
Временное ограничение: Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
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|
Physical Examination - by Treatment Week - Abdomen
Временное ограничение: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
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Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Cardiovascular
Временное ограничение: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
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Physical Examination - by Treatment Week - HEENT
Временное ограничение: 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
Временное ограничение: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Musculoskeletal
Временное ограничение: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Neurological
Временное ограничение: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Respiratory
Временное ограничение: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
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Physical Examination - by Treatment Week - Skin
Временное ограничение: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
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Соавторы и исследователи
Соавторы
Следователи
- Главный следователь: Djamchid Lotfi, MD, Hope Biosciences Stem Cell Research Foundation
Публикации и полезные ссылки
Общие публикации
- Meirelles Lda S, Fontes AM, Covas DT, Caplan AI. Mechanisms involved in the therapeutic properties of mesenchymal stem cells. Cytokine Growth Factor Rev. 2009 Oct-Dec;20(5-6):419-27. doi: 10.1016/j.cytogfr.2009.10.002. Epub 2009 Nov 18.
- Garretti F, Agalliu D, Lindestam Arlehamn CS, Sette A, Sulzer D. Autoimmunity in Parkinson's Disease: The Role of alpha-Synuclein-Specific T Cells. Front Immunol. 2019 Feb 25;10:303. doi: 10.3389/fimmu.2019.00303. eCollection 2019.
- Musial-Wysocka A, Kot M, Majka M. The Pros and Cons of Mesenchymal Stem Cell-Based Therapies. Cell Transplant. 2019 Jul;28(7):801-812. doi: 10.1177/0963689719837897. Epub 2019 Apr 24.
- Giannini EG, Testa R, Savarino V. Liver enzyme alteration: a guide for clinicians. CMAJ. 2005 Feb 1;172(3):367-79. doi: 10.1503/cmaj.1040752.
- Kalia LV, Lang AE. Parkinson's disease. Lancet. 2015 Aug 29;386(9996):896-912. doi: 10.1016/S0140-6736(14)61393-3. Epub 2015 Apr 19.
- Dimarino AM, Caplan AI, Bonfield TL. Mesenchymal stem cells in tissue repair. Front Immunol. 2013 Sep 4;4:201. doi: 10.3389/fimmu.2013.00201.
- Cuenca L, Gil-Martinez AL, Cano-Fernandez L, Sanchez-Rodrigo C, Estrada C, Fernandez-Villalba E, Herrero MT. Parkinson's disease: a short story of 200 years. Histol Histopathol. 2019 Jun;34(6):573-591. doi: 10.14670/HH-18-073. Epub 2018 Dec 12.
- Goetz CG. The history of Parkinson's disease: early clinical descriptions and neurological therapies. Cold Spring Harb Perspect Med. 2011 Sep;1(1):a008862. doi: 10.1101/cshperspect.a008862.
- Stoker TB, Greenland JC, editors. Parkinson's Disease: Pathogenesis and Clinical Aspects [Internet]. Brisbane (AU): Codon Publications; 2018 Dec 21. Available from http://www.ncbi.nlm.nih.gov/books/NBK536721/
- Armstrong MJ, Okun MS. Diagnosis and Treatment of Parkinson Disease: A Review. JAMA. 2020 Feb 11;323(6):548-560. doi: 10.1001/jama.2019.22360.
- Tambasco N, Romoli M, Calabresi P. Levodopa in Parkinson's Disease: Current Status and Future Developments. Curr Neuropharmacol. 2018;16(8):1239-1252. doi: 10.2174/1570159X15666170510143821.
- Marsden CD. Problems with long-term levodopa therapy for Parkinson's disease. Clin Neuropharmacol. 1994;17 Suppl 2:S32-44.
- Coppin L, Sokal E, Stephenne X. Thrombogenic Risk Induced by Intravascular Mesenchymal Stem Cell Therapy: Current Status and Future Perspectives. Cells. 2019 Sep 27;8(10):1160. doi: 10.3390/cells8101160.
- Tatsumi K, Ohashi K, Matsubara Y, Kohori A, Ohno T, Kakidachi H, Horii A, Kanegae K, Utoh R, Iwata T, Okano T. Tissue factor triggers procoagulation in transplanted mesenchymal stem cells leading to thromboembolism. Biochem Biophys Res Commun. 2013 Feb 8;431(2):203-9. doi: 10.1016/j.bbrc.2012.12.134. Epub 2013 Jan 9.
- Tan EK, Chao YX, West A, Chan LL, Poewe W, Jankovic J. Parkinson disease and the immune system - associations, mechanisms and therapeutics. Nat Rev Neurol. 2020 Jun;16(6):303-318. doi: 10.1038/s41582-020-0344-4. Epub 2020 Apr 24.
- Ra JC, Shin IS, Kim SH, Kang SK, Kang BC, Lee HY, Kim YJ, Jo JY, Yoon EJ, Choi HJ, Kwon E. Safety of intravenous infusion of human adipose tissue-derived mesenchymal stem cells in animals and humans. Stem Cells Dev. 2011 Aug;20(8):1297-308. doi: 10.1089/scd.2010.0466. Epub 2011 Mar 17.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- HBPD04
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .