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临床试验/NCT01446614
NCT01446614Unknown1 期

PhaseⅠ/ⅡTrial of Autologous Bone Marrow Derived Mesenchymal Stem Cells to Patients With Parkinson's Disease.

Guangzhou General Hospital of Guangzhou Military Command1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年10月1日最近更新:
适应症

试验速览

阶段
1 期
发起方
入组人数
20
试验地点
1
主要终点
Number of participants with adverse events

研究概览

简要总结

The study is a phase I/II trial designed to establish the safety and efficacy of intravenous administration of autologous bone marrow derived mesenchymal stem cells to patients with Parkinson's disease.

详细描述

Parkinson's disease (PD) is a common progressive neurodegenerative disorder caused by the loss of dopaminergic neurons in the substantia nigra. A combination of genetic and environmental factors is likely to be important in producing abnormal protein aggregation within select groups of neurones, leading to cell dysfunction and then death. A large number of agents together with surgical interventions are now available to treat early and late complications of PD, but they are suffer from two main drawbacks: side effects and loss of efficacy with disease progression.

Bone marrow (BM) derived mesenchymal stem cells (MSCs) an differentiate under certain circumstances into cells from various neuronal and glial type lineages; they also exert immunomodulatory effects. PD-derived MSCs are similar to normal MSCs in phenotype, morphology, and multidifferentiation capacity. Moreover, PD-derived MSCs are capable of differentiating into neurons in a specific medium with up to 30% having the characteristics of dopamine cells. These findings indicate that MSCs derived from PD patients' bone marrow may be a promising cell type for cellular therapy.

BM-MSCs cultured with a cocktail of growth factors (containing FGF and BDNF) differentiate into neuronal/glial lineage cells with a predominance of cells expressing astrocytes' markers. They were effective in suppression of chronic EAE in mice and induced neuroprotection, preserving most of the axons in the CNS of successfully-treated animals. Histopathological studies revealed that MSCs could efficiently migrate into the CNS inflamed tissue (both when administered intravenously and intraventricularly) and differentiated into cells expressing neural-glial lineage markers. Such an approach may provide a feasible and practical way for PD.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with current diagnosis of idiopathic Parkinson's disease.
  • Age 30 to
  • Experiencing motor complications despite optimized levodopa treatment.
  • PD of Stage 2,2.5,3 or 4 of Hoehn-Yahr staging.
  • Time between diagnosis and enrollment greater than 2 years.
  • No significant cognitive impairment. MMSE >
  • Ability to understand and the willingness to sign a written informed consent document.

排除标准

  • Patients may not be receiving any other investigational agents within 4 weeks of study entry.
  • History of allergic reactions attributed to compounds of similar biologic composition to mesenchymal stem cells.
  • Primary hematologic diseases.
  • Patients undergo intracranial surgeries or implantation of a device for Parkinson's disease.
  • Psychiatric, addictive or any other disorder that compromises ability to give a truly informed consent and perform all study assessments.
  • Atypical or secondary parkinsonism.
  • Malignancy within the last 5 years.
  • Any other serious medical illness that might preclude safe participation in the study.
  • Pregnant or breastfeeding women.
  • HIV-positive patients.

结局指标

主要结局

Number of participants with adverse events

时间窗: 1 month after transplantation

次要结局

  • Effect assessment(12 months after transplantation)

研究者

发起方
Guangzhou General Hospital of Guangzhou Military Command
申办方类型
Other

研究点 (1)

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