JPRN-jRCT2013190010招募中2 期
Intravenous infusion of autologous mesenchymal stem cells (MSC) from bone marrow for Amyotrophic lateral sclerosis (ALS) patients: double-blind randomized controlled trial - STR01-09
HISAHARA SHI0 个研究点目标入组 40 人开始时间: 2020年3月4日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 80age old（—）
- 性别
- All
入选标准
- •[Inclusion criteria at the time of first registration]
- •(1) ALS that meets the diagnostic criteria (Updete Awaji ) as definite or probable
- •(2) ALS Severity is class1 to 3
- •(3) ALS onset within 3 years
- •(4) %FVC greater than or equal to 70%
- •(5) Completion of this trial is expected
- •(6) Age between 20 to 80
- •(7) The written informed consent obtained as much as possible from subjects. If the subject does not have ability to write etc, the written informed consent obtained from legal representative.
- •[Inclusion criteria at the time of second registration]
- •(1) ALS Severity is class1 to 3
- •(2) %FVC greater than or equal to 70%
- •(3) Completion of this trial is expected
- •(4) Ready to infuse of investigational product which satisfies specification of acceptance criteria
- •(5) Standard treatment (Riluzole, Edaravone,etc.) is not scheduled to change
排除标准
- •[Exclusion criteria at the time of first registration]
- •(1) Bulbar paralysis related ALS or uncontrollable mental symptoms
- •(2) Diagnosed as dementia
- •(3) Diagnosed as HBV, HCV, HIV, HTLV-1, syphilis or Human parvovirus B19 by initial screening
- •(4) Pancytopenia (WBC <2000/uL, Hb <10.0g/dl, Plt <100000/uL)
- •(5) Past history of neoplasms (except CR), severe diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism, severe mental and behavioural disorders, severe diseases of the nervous system, severe congenital malformations, deformations and chromosomal abnormalities
- •(6) Past history of penicillin and streptomycin allergy or other severe allergy (shock, anaphylactoid symptoms etc.)
- •(7) Poor general condition due to [Endocrine, nutritional and metabolic diseases, Mental disorders, diseases of nervous system, diseases of circulatory system (Uncontrollable and refractory heart failure, moderate or severe valvular heart disorder, uncontrollable and refractory atrial fibrillation, refractory atrial and ventricular thrombus, history of ischemic heart disease and PCI within the past 12 months, serious arrhythmia), diseases of the respiratory system, diseases of the digestive system, diseases of the musculoskeletal system and connective tissue, diseases of the genitourinary system (dialysis etc), injury, poisoning and certain other consequences of external causes etc]
- •(8) Intracranial lesion (severe asymptomatic lesion, severe old infarction, severe white matter lesion, severe multiple lesions, severe microbleeding or multiple hemosiderosis, Cerebrovascular diseases such as Moyamoya disease or high risk AN etc, severe intracerebral hemorrhage etc) including past history of these issues.
- •(9) 70% or more stenosis or dissecting in the artery causing cerebral infarction even though after revascularization (except complete thrombotic occlusion)
- •(10) Severe arteriosclerotic change and calcification in the blood vessels of head and neck.
- •(11) Preoperative possible uncontrollable HT under depressor therapy (systolic pressure more than 140mmHg, diastolic pressure more than 90mmHg)
- •(12) Participation in other clinical trials or past history of cellular therapy
- •(13) Pregnant or possibly pregnant, nursing women or those who plan to be pregnant during the study period or male patients who wish partner to get pregnant
- •(14) Other patients judged by investigators as inappropriate for this study
- •[Exclusion criteria at the time of second registration]
- •(1) Past history of neoplasms (except CR), severe diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism, severe mental and behavioural disorders, severe diseases of the nervous system, severe congenital malformations, deformations and chromosomal abnormalities
- •(2) Past history of penicillin and streptomycin allergy or other severe allergy (shock, anaphylactoid symptoms etc.)
- •(3) Poor general condition due to [Endocrine, nutritional and metabolic diseases, Mental disorders, diseases of nervous system, diseases of circulatory system (Uncontrollable and refractory heart failure, moderate or severe valvular heart disorder, uncontrollable and refractory atrial fibrillation, refractory atrial and ventricular thrombus, history of ischemic heart disease and PCI within the past 12 months, serious arrhythmia), diseases of the respiratory system, diseases of the digestive system, diseases of the musculoskeletal system and connective ti
研究者
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