NCT06167681招募中1 期
A Phase I/II Study to Assess the Safety, Tolerability and Efficacy of NouvNeu001 Injection for Mid- to Late-stage Parkinson's Disease
iRegene Therapeutics Co., Ltd.2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年1月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Motor Function
研究概览
简要总结
This clinical trial is designed to evaluate the safety, tolerability and preliminary efficacy of a single injection of NouvNeu001 (Human Dopaminergic Progenitor Cells Injection) in patients with Parkinson's disease.
详细描述
This is a multi-center, single arm, and open label trial. The NouvNeu001 will be transplanted into bilateral putamen/striatum using stereotactic neurosurgery. Subjects will take immunosuppressants to prevent potential immune rejection for 24 to 36 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50-75 years old, male or female
- •Able to understand the rationale of the clinical trial and sign informed consent form (ICF)
- •Diagnosis of Parkinson's Disease in accordance with the MDS clinical diagnostic criteria for Parkinson's disease (2015)
- •Diagnosis of Parkinson's Disease made between 4 to 20 years ago
- •Medically suitable for neurosurgery under anesthesia and able to participate in Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) scan.
- •Hoehn-Yahr staging for "off" episodes is 2.5 to 4
- •The MDS-UPDRS Part III (MDS-UPDRS-III) score in the "off" state > 35, and positive for the Acute Levodopa Challenge Test (ALCT)
- •Acceptable laboratory test results during screening and prior to transplantation
排除标准
- •Atypical Parkinsonism
- •Patients who have had previous pallidotomy, deep brain stimulation (DBS) surgery, striatal or extrapyramidal surgery, brain stereotaxy or other brain surgery; as well as other surgical procedures that are judged by the investigator to affect patient's participation in this study
- •Patients who have a previous head CT/MRI examination showing cerebral trauma, vascular malformation, hydrocephalus, brain tumor, etc., and patients who have brain imaging abnormalities in the striatum or other brain areas leading to a significantly increased risk for surgery.
- •Patients with a history of severe cardiovascular and cerebrovascular diseases
- •Patients with a history of malignant tumors
- •Patients who have had previous cellular therapy
- •Patients with active disseminated intravascular coagulation and significant hemorrhagic tendency within 3 months prior to screening, or who cannot temporarily suspend anti-platelet agents or other anti-coagulant medications for at least 5 days before surgery
- •Patients with long-term, heavy use of glucocorticoids or immunosuppressive drugs within 3 months prior to signing the ICF
- •Patients with a history of mental illness who are deemed unfit to participate in the study by the investigator; or a history of suicidal ideation or suicide attempts within the past year or currently;
- •Patients who have used botulinum toxin within 6 months prior to signing the ICF
- •Patients with active epilepsy or currently on anti-epileptic drugs
- •Patients with a history of dementia or severe cognitive disorder, or the score of MDS-UPDRS 1.1 during screening is > 3; poor compliance, inability to accurately keep diary, and/or inability to sign ICF due to dementia
- •Patients with severe depression or with severe anxiety during screening;
- •Patients with the following abnormalities during screening, including: Abnormal coagulation; Abnormal immunological tests, and assessed by the investigator it is not suitable to participate in the trial; Hypertensive patients with poorly controlled blood pressure and patients with severe postural hypotension; Diabetic patients with poorly controlled blood glucose
- •Patients with surgical contraindications, or with other surgical procedures within 6 months before screening which, in the opinion of the investigator, have an impact on this trial; Patients with other neurosurgical contraindications
- •Patients with other combined severe systemic diseases, such as pulmonary heart disease, moderate to severe asthma, severe chronic obstructive pulmonary disease (COPD)
- •Presence of one of the following: positive for human immunodeficiency virus (HIV) antibody, treponema pallidum antibody, hepatitis C virus (HCV) antibody and HCV RNA; Hepatitis B virus (HBV) surface antigen positive and HBV DNA copy number > detection of normal values; Tuberculosis is in the active stage; Other active infections that the investigator believes may affect Patients' participation in the study or affect study outcomes;
- •Patients with alcohol addiction or positive for drug of abuse testing
- •Patients with a history of contraindication or allergy to the drugs used during the study or any of its components, or are allergic to the same drugs or other macrolides, or have allergies;
- •Female of childbearing potential who are not surgically sterilized/premenopausal/unwilling to use medically approved effective contraception with 2 years after administration of investigational drug and lactating women; men who are not surgically sterilized/unwilling to use medically approved effective contraception with 2 years after administration of investigational drug
- •Patients who have received electric shock therapy within 30 days prior to surgery
- •Patients who are participating in other clinical trials, or have been enrolled in other clinical studies and received intervention therapy within 3 months prior to the surgery
- •Patients with poor compliance based on clinical evaluation of the investigator
- •Patients who are being treated with drugs such as apomorphine, or levodopa/carbidopa infusion therapy
- •Patients with severe dyskinesia in both on- and off-drug states
研究组 & 干预措施
NouvNeu001
Experimental
干预措施: Human Dopaminergic Progenitor Cells (Biological)
结局指标
主要结局
Motor Function
时间窗: 24 weeks post-transplant
Changes in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅲ score from baseline to 24 weeks post-transplant. MDS-UPDRS Part III assesses the motor signs of PD, a higher score indicates more severe symptoms of PD.
Safety and Tolerability
时间窗: 24 weeks and 48 weeks post-transplant
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
次要结局
- The Motor Function and Non-motor Function(48 weeks and 96 weeks post-transplant)
- Continued Safety and Tolerability(96 weeks and 5 years post-transplant)
研究者
研究点 (2)
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