KCT0005954进行中（未招募）未知
A Double-blind, Randomized, Multicenter, Placebo-Controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Lenzumestrocel(Neuronata-R® inj.) in Patients with Amyotrophic Lateral Sclerosis
Corestemchemon0 个研究点目标入组 125 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 125
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 25(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •1) Subjects who show both upper motor neuron signs and lower motor neuron signs at the same time in neurological tests.
- •2) Among subjects diagnosed with familial or sporadic ALS, subjects falling into clinically definite ALS, probable ALS and probable ALS-lab supported according to The revised World Federation of Neurology El Escorial Criteria[Rix Brooks, 2000], during 17-weeks period prior to the administration and ALSFRS-R score (progression rate) of 1.03 ± 50%/month (meaning mean value in that total period).
- •3) For subjects who are under Riluzole treatment, those who have received stable dose of Riluzole for more than 28 days before screening visit.
- •4) Subjects with duration of disease of no more than 2 years from the first diagnosis date.
- •5) Subjects whose ALSFRS-R scores are in the range of 31~46 at the time of screening (P-V0).
排除标准
- •1) Subjects who received tracheostomy or use ventilators (including positive pressure ventilators; subjects who use non-invasive ventilation for sleep apnea may be allowed after review) at the time of screening (P-V0).
- •2) Subjects who received gastrotomy at the time of screening (P-V0).
- •3) Subjects for whom clinical efficacy evaluation is not possible because pulmonary functional tests cannot be conducted at the time of screening (P-V0) or subjects whose forced vital capacity is found to be not greater than 40%of the expected value.
- •4) Subjects who fall into above Class II according to the New York Heart Association's functional classification, who have showed myocardial infarction, unstable arrhythmia and/or other significant cardiovascular diseases such as unstable angina in the past 3 months, or who show electrocardiographic signs of myocardial infarction or angina at the time of screening (P-V0) or who received stent insertion or coronary artery bypass grafting.
- •5) Subjects who have received other investigational products or edaravone within 3 month or 5 half-lives at the time of screening (P-V0) and lead in period visit L-V1 (evaluated by whichever is longer).
- •6) Subjects who have experienced epileptic seizure.
- •7) Subjects with severe renal disorder (serum creatinine: not less than 2.0 mg/dL).
- •8) Subjects with severe hepatic disorder (ALT, AST, or bilirubin: over 2.0 times of the normal upper limit).
- •9) Subjects who show hemorrhagic tendency at the time of screening (PT and aPTT > 1.5 x ULN)
- •10) Subjects who are found to have active viral infections (HBsAg, HCV Ab, HIV Ab, CMV IgM, EBV IgM, HSV IgM and Treponema pallidum) at the time of screening.
- •11) Subjects with hypersensitivity to antibiotics (penicillin or streptomycin).
- •12) Subjects who have ever received any cell therapy product for the same disease.
- •13) Subjects with any malignant tumor in the past 5 years before screening, except malignant tumors with very low risk of metastasis or death.
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