IRCT20200904048610N1尚未招募1 期
Safety and Efficacy of Bone marrow derived-mesenchymal stem cells in comparison with their exosomes in Amyotrophic Lateral Sclerosis: A randomized controlled phase 1 study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 5
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
- 18 years 至 no limit（—）
- 性别
- All
入选标准
- •Definitive diagnosis of ALS (according to laboratory findings or El Escorial criteria)
- •Duration of symptoms less than 36 months
- •Progressive muscle weakness in the lower limb, based on EMG in the lower limb bilaterally
- •Mandatory vital capacity more than 60% of the predicted normal in lying on the back
- •Age 18 and above
- •Ability to provide informed consent
- •The person can be geographically available and refer for the required visits.
- •Being accompanied by a caregiver and performing the care needed by him during the study
- •Failure to use riluzole or a fixed dose in the previous 30 days or more
- •In women of reproductive age, having a negative pregnancy test before stem cell injection
- •Medically able to perform thoracolumbar laminectomy or laminoplasty as determined by the surgeon.
- •Medically able to tolerate an immunosuppressive regimen.
排除标准
- •Use of aggressive breathing equipment
- •Diagnosis of other significant or unstable medical and clinical conditions that can interfere with the study.
- •The occurrence of any of the following situations: Alcohol consumption with illegal and non-prescription drugs, Appearance of known immunodeficiency syndrome, Unstable medical conditions, Occurrence of unstable psychiatric diseases including psychosis, or major depression
- •People of reproductive age who are not interested in birth control.
- •Receiving any other investigational device or drug
- •Any condition in the lower limb that prevents the testing of muscle strength
- •Any condition that the specialist feels can cause difficulty in performing injections and follow-ups
- •Any condition or subset of ALS that the researcher feels could interfere with the study or final interpretation.
研究者
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