Идёт набор NCT06978920

A Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of NCR201 in the Treatment of Subjects With Parkinson's Disease

Фаза I С лечением Parkinson Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Allogeneic dopaminergic neural precursor cell(NCR201).
Кому может быть актуально: Состояния в реестре: Parkinson Disease. Базовые параметры: 40 лет — 75 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase I, Open Label, Single Arm, Dose Escalation and Dose Expansion Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Human Induced Pluripotent Stem Cell Derived Dopaminergic Progenitor Cells (NCR201) Injection in the Treatment of Subjects With Parkinson's Disease

Обзор

The goal of this clinical trial is to evaluate the safety, tolerability and preliminary efficacy that NCR201 has on Parkinson's disease (PD) patients.

Подробное описание

Parkinson's disease (PD) is a common neurodegenerative disease in the middle-aged and elderly. It is the "third killer" of the middle-aged and elderly after tumors and cardiovascular and cerebrovascular diseases. Its main clinical manifestations are resting tremor, reduced voluntary movement, muscle rigidity, postural reflex impairment, and autonomic dysfunction, which seriously affect patients' work ability and quality of life. It is estimated that nearly 100,000 people in China become new Parkinson's patients every year. Experts from the World Health Organization predict that the number of Parkinson's patients in China will reach 5 million in 2030, which will be more than half of the world's total. As the disease progresses, the symptoms of Parkinson's patients will become increasingly severe. The high prevalence and high disability rate of Parkinson's disease bring heavy burdens to individuals, families, and society.

Вмешательства

Препарат Allogeneic dopaminergic neural precursor cell(NCR201)
Bilateral implantation

Первичные конечные точки

Incidence and severity of adverse events. [Срок оценки: Within 24 weeks post-transplantation]

Вторичные конечные точки (9)

Assessment of changes in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part III, in comparison with baseline values. [Срок оценки: Within 24 months post-transplantation]
Assessment of changes in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part I,II,IV, in comparison with baseline values. [Срок оценки: Within 24 months post-transplantation]
Assessment of changes in Hoehn & Yahr scale in comparison with baseline values. [Срок оценки: Within 24 months post-transplantation]
Assessment of changes in Hamilton Depression Scale (HAMD)-17 in comparison with baseline values. [Срок оценки: Within 24 months post-transplantation]
Assessment of changes in Hamilton Anxiety Scale (HAMA)-14 in comparison with baseline values. [Срок оценки: Within 24 months post-transplantation]
Assessment of changes in Parkinson's Disease Questionnaire-39 (PDQ-39) in comparison with baseline values. [Срок оценки: Within 24 months post-transplantation]
Bilateral putamen standardized uptake value as demonstrated on positron emission tomography(PET) compared with baseline in the 'off' state. [Срок оценки: Within 24 months post-transplantation]
Patient L-dopa equivalent dose compared with baseline. [Срок оценки: Within 24 months post-transplantation]
Incidence and severity of adverse events. [Срок оценки: Within 24 months post-transplantation]

Критерии участия

Критерии включения

Ages between 40 and 75 years;
Diagnosed to be Parkinson's disease according to Parkinson's disease diagnostic criteria;
Disease history over 5 years;
Stable dose of dopamine treatment;
Able to undergo PET/CT/MRI detection;