NCT07118319招募中1 期
A Phase I Study to Assess the Safety, Tolerability and Preliminary Efficacy of Human Allogeneic Induced Pluripotent Stem Cells (iPSCs) -Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects With Amyotrophic Lateral Sclerosis
XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年9月15日最近更新:
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
- 12
- 试验地点
- 1
- 主要终点
- The incidence of XS228CN-related adverse events (AEs) and serious adverse events (SAEs) within 28 days after the last administration in ALS patients
研究概览
简要总结
A Phase I Study to Assess the Safety, Tolerability and Preliminary Efficacy of Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects with Amyotrophic Lateral Sclerosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years of age (inclusive of 18 and 75 years), regardless of gender;
- •Diagnosed of definite or probable ALS according to the revised EI Escorial criteria;
- •Respiratory function FVC at baseline was ≥70% of the predicted value (FVC%);
- •Patients with birth-potential (both male and female) must agree to use effective non-drug contraceptive measures from the time of signing the informed consent until 6 months after the conclusion of the trial;
- •Volunteer to participate in the clinical study, understand and sign the informed consent form.
排除标准
- •Subject has signs and symptoms of neuromuscular weakness, and other causes of muscle weakness cannot be ruled out;
- •Baseline body mass index (BMI) < 18.5 kg/m²;
- •Primary lateral sclerosis presenting only with upper motor neuron symptoms;
- •Significant psychiatric disorders that the investigator assesses may affect evaluation;
- •Diseases causing neurological or muscular dysfunction, such as metabolic muscle diseases or myasthenia gravis;
- •Diagnosed autoimmune diseases with uncontrolled severe arthritis or other conditions (e.g., lameness) that the investigator assesses may affect evaluation;
- •Acute active infections requiring antibiotics, antivirals, or antifungals that occurred within the 2 weeks prior to screening and are not controlled;
- •Subject diagnosed with active pulmonary tuberculosis or treated for suspected tuberculosis;
- •Diagnosed severe pulmonary diseases that the investigator assesses may affect evaluation;
- •Poorly controlled hypertension;
- •Previous or detected cardiac abnormalities;
- •A history of cirrhosis, chronic hepatitis, or liver function at screening;
- •A history of chronic kidney disease;
- •Previous history of bleeding, abnormal clotting, or being treated with anticoagulation;
- •Active hepatitis B, active hepatitis C, human immunodeficiency virus (HIV) antibody or treponema pallidum antibody positive at screening;
- •History of severe trauma or surgery and may affect the assessment judged by investigator;
- •Subjects with contraindications to lumbar puncture, including menifestations of injection site infection or high intracranial pressure.
- •Those who have had a malignant tumor within 5 years prior to screening or are undergoing antitumor therapy;
- •Have participated in other clinical trials within 3 months prior to screening;
- •Pregnant or breastfeeding women;
- •Subject who is judged by the investigator to be unsuitable for the clinical trial.
研究组 & 干预措施
5.0×10^7 cells/person/dose
Experimental
intrathecal injection
干预措施: Human Allogeneic Induced Pluripotent Stem Cells (iPSCs) -Derived Motor Neuron Progenitor Cells (XS228CN) (Drug)
1.0×10^8 cells/person/dose
Experimental
intrathecal injection
干预措施: Human Allogeneic Induced Pluripotent Stem Cells (iPSCs) -Derived Motor Neuron Progenitor Cells (XS228CN) (Drug)
结局指标
主要结局
The incidence of XS228CN-related adverse events (AEs) and serious adverse events (SAEs) within 28 days after the last administration in ALS patients
时间窗: within 28 days after the last administration
次要结局
未报告次要终点
研究者
研究点 (1)
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