NCT05691114招募中1 期
Precise Transplantation of Human Amniotic Epithelial Stem Cells Into Lateral Ventricle for Parkinson's Disease
Shanghai East Hospital1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2023年2月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Dose limiting toxicity (DLT)
研究概览
简要总结
This is a single-center, single-arm, dose escalation study, to explore the safety, tolerability and efficacy of human amniotic epithelial stem cells (hAESCs) for idiopathic Parkinson's disease (PD).
详细描述
hAESCs will be administration through the Ommaya reservoir implanted into the lateral ventricle of subjects with idiopathic PD.
This dose escalation will be followed by an exploratory expansion phase in 3 cohorts.
- Dose A (5×10^7 cells/dose)
- Dose B (1.0×10^8 cells/dose)
- Dose C (1.5×10^8 cells/dose).
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40-70 years old, with more than 5 years of idiopathic PD history
- •UPDRS-III off-time scores ≤49
- •MMSE scores ≥24
- •HAMD-17 scores < 25
- •H-Y on-time scores ≤4
- •reactive to levodopa or dopa agonists
- •PD medication dose is stable for more than 2 months
- •no general anesthesia contraindications, no stereotactic surgery contraindications or other conditions that interfere with clinical evaluation
- •no abnormalities affecting cell transplantation by cranial MRI
- •no participation of other clinical trials 3 months before signing the informed consent
排除标准
- •secondary PD or Parkinson's syndrome
- •subcutaneous apomorphine treatment
- •scoring ≥ 2 on UPDRS-I item 2, or ≥ 2 on UPDRS-II item 13; or ≥ 3 on UPDRS-II item14
- •history of intracranial surgery or device implantation, including deep brain stimulation, within 2 years prior to signing informed consent
- •history of seizures or prophylactic application of antiepileptic drugs
- •other serious central nervous system disorders
- •history of stem cell therapy
- •subject who had undergone a major surgery within 3 months and will undergo a major surgery within the next 6 months prior to signing informed consent
- •autoimmune disease or current use of Immunosuppressants
- •subjects with comorbid cardiac disease, for example, but not limited to, ischemic heart disease, congestive heart failure, significant arrhythmias or cardiac conduction block
- •poorly controlled hypertension, diabetes mellitus, or comorbid endocrine system disorders, pulmonary disorders, gastrointestinal system disorders, serious infections, malignancies, etc.
- •positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV) antibodies, or Treponema pallidum antibody
- •abnormalities in liver or kidney function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST) is less than 2.5 times the upper limit of normal, blood urea nitrogen (BUN) or creatinine(Cr) are less than 1.5 times the upper limit of normal, or serum albumin < 30.0 g/L
- •abnormalities in hematologic test: coagulation disorders or ongoing anticoagulation therapy; moderate to severe anemia; platelet count < 80 × 10^9/L
- •inability to undergo MRI and positron emission tomography (PET) examinations
- •subject with severe allergies
- •women of childbearing potential (WOCBP) or subject is a man with a WOCBP partner, who are unwilling to take contraception during the trial
- •pregnant or lactating females
- •other conditions deemed by the investigator to be inappropriate for enrollment.
结局指标
主要结局
Dose limiting toxicity (DLT)
时间窗: 12 months
The occurrence of DLT.
Number of participants with adverse event (AE), serious adverse event(SAE) and adverse events of special interest (AESI)
时间窗: 12 Months
According to CTCAE V5.0, AE, SAE and AESI evaluated by laboratory examination, measurement of vital signs, physical examination, and subjects' symptoms to detect new abnormalities and/or deterioration of previous conditions. AESI is defined as intracranial infection, hemorrhage, rejection, edema, as well as acute allergic reactions and ectopic mass formation associated with the therapy.
次要结局
- Change from baseline in the UPDRS-III (Unified Parkinson's Rating Scale part III/motor part) scores(12 months)
- Change from baseline in the UPDRS on-time total scores(12 months)
- Change from baseline in the UPDRS off-time total scores(12 months)
- Change from baseline in sum of the UPDRS-II and UPDRS-III scores(12 months)
- Changes from baseline in the Hoehn and Yahr scale (H-Y)(12 months)
- Changes from baseline in the Mini-Mental State Examination (MMSE)(12 months)
- Changes from baseline in the Parkinson's Disease Questionnaire (PDQ-39) scores(12 months)
- Change from baseline in the Parkinson's Disease Sleep Scale (PDSS) scores(12 months)
- Changes in the Hamilton Depression-17 (HAMD-17) Scale scores(12 months)
研究者
Jingwen WU
Principal Investigator
Shanghai East Hospital
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Therapeutic Trial of Human Amniotic Epithelial Cells Transplantation for Primary Ovarian FailurePrimary Ovarian InsufficiencyInfertilityPremature Ovarian FailureNCT02912104International Peace Maternity and Child Health Hospital36
Unknown
不适用
Human Amniotic Epithelial Cells Treatment for Ovarian InsufficiencyPremature Ovarian FailureNCT03207412The Second Affiliated Hospital of Chongqing Medical University20
尚未招募
早期 1 期
Precise Transplantation of hAESCs Into the Ventricle for Parkinson's Disease.Parkinson's DiseaseNCT05435755Shanghai East Hospital12
Unknown
1 期
Human Amniotic Epithelial Cells for Asherman's SyndromeAsherman's SyndromeNCT03223454The Second Affiliated Hospital of Chongqing Medical University50
已完成
1 期
Human Placental-Derived Stem Cell TransplantationMucopolysaccharidosis IMucopolysaccharidosis VINiemann-Pick DiseaseBatten DiseaseMetachromatic LeukodystrophyWolman DiseaseKrabbe's DiseaseGaucher's DiseaseDiamond-Blackfan AnemiaAmegakaryocytic ThrombocytopeniaAcute Myelogenous LeukemiaAcute Lymphocytic LeukemiaMyelodysplastic SyndromeSevere Aplastic AnemiaFucosidosisAdrenoleukodystrophyNCT01586455New York Medical College43