jRCT2063200047已完成不适用
A single-center, exploratory clinical trial evaluating the safety and efficacy of CL2020 in patients with amyotrophic lateral sclerosis (A single-center, exploratory clinical trial evaluating the safety and efficacy of CL2020 in patients with amyotrophic lateral sclerosis)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 主要终点
- Safety and tolerability
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 80age old under（—）
- 性别
- All
入选标准
- •(1) Patients with new onset or within 2 years after onset at the start of screening
- •(2) Patients with 1 or 2 severity according to ALS severity criteria
- •(3) Subjects who can receive treatment on an outpatient basis
排除标准
- •(1) Patients undergoing tracheostomy
- •(2) Patients who have worn non-invasive respiratory assist device
- •(3) Patients with% FVC of 80% or less
- •(4) Patients with chronic obstructive pulmonary disease (COPD)
- •(5) Patients with impaired respiratory function who complained of dyspnea at the end of screening(ALS FRS-R:
- •Respiratory failure, any of those 3 items is 3 points or less)
- •(6) Patients using Edaravone injection within 4 weeks before the start of screening
- •(7) Patients who started taking Riluzole, or patients who changed or discontinued the dose after obtaining informed consent
- •(8) Patients with cognitive dysfunction (Alzheimer's disease and other dementia, Parkinson's disease, or other neurological disorders, etc.) that principal investigator/sub investigator has determined to affect their ability to participate in this trial or the evaluation of the clinical trial
- •(9) Patients with a history of surgery on the spine such as cervical spondylosis and herniated disc after the onset of ALS, or patients scheduled for surgery during the clinical trial period
- •(10) Patients who could not rule out the possibility of diseases symptoms that require differential diagnosis such as cervical spondylosis and multifocal motor neuropathy
- •(11) Patients with serious respiratory, cardiovascular or hepato-renal disorders
- •(12) Patients with complication of malignant tumor or history of it (however, patients who in
- •remission for 5 years could be included)
- •(13) Patients with collagen disease and related diseases
- •(14) Patients with severe diabetes mellitus (HbA1C >10%)
- •(15) Patients with active infectious disease requiring medical treatment(including HB antigen, HCV antibody, HIV antibody, HTLV-1 antibody, Syphilis)
- •(16) Patients who received high-dose intravenous immunoglobulin therapy within 8 weeks before the start of screening
- •(17) Patients who are taking systemic steroid hormone or immunosuppressant drugs
- •(18) Patients who have been treated with bone marrow transplantation or stem cell therapy
- •(19) Patients who are pregnant/possibly pregnant or breastfeeding
- •(20) Male or female patients who could not agree to birth control explained by principal investigator/sub investigator from completion of informed consent until completion of observation period
- •(21) Patients with history of allergy to aminoglycoside antibiotics including kanamycin
- •(22) Patients with history of allergy to human serum albumin formula or xenogeneic-derived protein (cow and swine)
- •(23) Patients who participated in other clinical trials within 12 weeks before completion of informed consent for the clinical trial
- •(24) Patients with or with a history of drug allergies or severe allergic diseases (anaphylactic shock, etc.)
- •(25) Patients with severe complications that principal investigator/sub investigator judged as inappropriate
- •(26) Patients who the principal investigator/sub investigator judged as inappropriate to participate
结局指标
主要结局
Safety and tolerability
as measured by incidence of Adverse events (AEs), adverse drug reactions (ADRs)
次要结局
未报告次要终点
研究者
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