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Набор скоро начнётся NCT07212088

Stereotactic Intracerebral Injection of Allogenic IPSC-DAPs in Patients 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: ALC01 therapy.
Кому может быть актуально
Состояния в реестре: Parkinson Disease. Базовые параметры: 55 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
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Официальное название

Stereotactic Intracerebral Injection of Allogenic Induced Pluripotent Stem Cell-derived Dopamine Progenitor Cells in Patients With Parkinson's Disease

Обзор

Parkinson's disease is a progressive neurodegenerative disorder characterized by high morbidity due to the limited regenerative capacity of dopaminergic neurons in the brain. Current drug treatments primarily manage symptoms but do not halt or reverse neuronal loss. Cellular replacement therapy has emerged as a potential strategy to restore dopaminergic function and address the underlying neuronal deficits. This study aims to evaluate the safety, feasibility, and efficacy of transplanting dopaminergic neurons into the brain to improve motor function and quality of life in patients with advanced Parkinson's disease.

Подробное описание

Patients with Parkinson's disease will be treated with allogenic induced pluripotent stem cell-derived dopamine progenitor cells (iPSC-DAPs). These cells will be transplanted directly into the striatum to restore dopamine-producing capacity. Patients will be evaluated at 1, 3, 6, 9 and 12 months after transplantation for safety, feasibility, and efficacy.

Вмешательства

  • Биопрепарат ALC01 therapy
    A single dose of iPSC-DAPs will be administered into the putamen on each side of the brain

Первичные конечные точки

  • Incidence and servility of Treatment-Emergent Adverse Events [Срок оценки: From baseline to 12 months post surgery]
Вторичные конечные точки (5)
  • Changes in motor function [Срок оценки: From baseline to 12 months post surgery]
  • Changes in the Hoehn and Yahr scale [Срок оценки: From baseline to 12 months post surgery]
  • Changes in quality of life (QoL) [Срок оценки: From baseline to 12 months post surgery]
  • Change in PD medication usage [Срок оценки: From baseline to 12 months post surgery]
  • 18-F DAT PET uptake [Срок оценки: Baseline, 6 and 12 months post surgery]

Критерии участия

Критерии включения

  • Able to sign informed consent and comply with the study protocol
  • 55-75 years of age, at the time of signing informed consent
  • Diagnosed to be Parkinson's disease patients over 5 years
  • Taking levodopa, but with complications of therapy such as wearing off and/or dyskinesia
  • At least 3 hours accumulative "off" time per day
  • Hoehn and Yahr Stage 3 - 4 in the off state at screening
  • Dopamine drug responsiveness demonstrated by a positive "on/off" test with at least a 30% improvement on UPDRS III (motor) scale

Критерии исключения

  • Patients with the following concomitant conditions or disorders: Epilepsy；Multiple sclerosis；Unable to give consent due to dementia；Atypical Parkinsonism；Genetic Parkinson's disease；Suicidal ideation associated with intent or plan in the past 12 months；History of psychosis；History of subarachnoid hemorrhage；History of stroke or transient ischemic attack
  • Patient with unstable vital sign at screening and/or prior to the surgery
  • Estimated Glomerular Filtration Rate (eGFR) < 60 ml/min/1.73m2
  • Liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the ULN.
  • Hematologic abnormality: hemoglobin <10 mg/dL or platelet count < 100,000/mL
  • International normalized ratio (INR) ≥ 1.3 not due to a reversible cause
  • Patients with autoimmune disorders
  • Patients with HIV and/or active HBV or HCV
  • Patients who are unable to undergo MRI and PET/CT
  • Patients with an expected life expectancy of <1 year
  • Patients who have had active malignancies
  • Patients currently receive levodopa-carbidopa intestinal gel or apomorphine treatment
  • Patients who have history of pallidotomy or thalamotomy or deep brain stimulation (DBS) surgery
  • Received cell or gene therapy (autologous or allogeneic) within the previous 12 months
  • Participation in an investigational therapeutic or device trial within 30 days of consent
  • Women who are pregnant or breast-feeding
  • Other conditions that researchers consider not suitable to participate in this study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Second Affiliated Hospital Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT07212088 · (2025)LSYD(1419)H

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗