Study to Assess the Safety and Efficacy of an IT Administration of ADSC in SPMS
赞助:
Stem Cell Medicine Ltd.
合作者:
信息的提供 (责任方):
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| 追踪信息 | |||
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| 首次提交日期 ICMJE | September 30, 2018 | ||
| 首次发布日期e ICMJE | October 4, 2018 | ||
| 最后更新发布日期 | October 4, 2018 | ||
| 预计研究开始日期 ICMJE | February 1, 2019 | ||
| 预计主要完成日期 | February 1, 2021 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Adverse Events (AEs) reported during the trial[ Time Frame: 48 weeks ] Safety data will be collected following the one IT administration of MSC at baseline visit |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Study to Assess the Safety and Efficacy of an IT Administration of ADSC in SPMS | ||
| 正式标题 ICMJE | A Prospective, Single Center, Open Label, Dose Escalation Phase I/IIa Study to Assess the Safety and Efficacy of an Intrathecal Administration of SCM-010 in Subjects With Secondary Progressive Multiple Sclerosis (SPMS) | ||
| 简要概况 | Prospective, single center, open label, phase I/IIa escalating dose study. To evaluate the safety and efficacy of escalating doses of SCM-010 in subjects with SPMS. |
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| 详细说明 | Twelve (12) SPMS subjects will be enrolled in this study in two dose cohorts. Each subject will receive SCM- 010 by intrathecal (IT) administration at baseline and will be followed up for 24 weeks for efficacy and 48 weeks for safety. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 1/Phase 2 | ||
| 研究设计 ICMJE | 分配: Non-Randomized 干预模型: Sequential Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
12 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | February 1, 2021 | ||
| 预计主要完成日期 | February 1, 2021 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: 1. Male or female subjects (18-60 years of age) diagnosed with SPMS. 2. SPMS defined as relapsing-remitting disease followed by progression of disability independent of or not explained by multiple sclerosis (MS) relapses for at least 2 years. 3. Subjects should be ambulatory with an EDSS score of 3-6.5 (inclusive) at screening and baseline visits. 4. Subjects should be able to go through a lipoaspiration procedure, evaluated by the study's plastic surgeon. 5. Women capable of child bearing must have a negative urine pregnancy test at screening and baseline visits. 6. Subjects must use an adequate contraceptive method throughout the study. 7. Coagulation tests including INR, PTT and prothrombin time (PT) within normal range. 8. Subjects must be willing and able to comply with the protocol requirements for the duration of the study. 9. Ability to provide written informed consent. Exclusion Criteria: 1. Relapsing remitting multiple sclerosis (RRMS) or primary progressive multiple sclerosis (PPMS) as defined by the revised McDonald criteria. 2. Any chronic central nervous system (CNS) disease other than SPMS. 3. Clinical relapse within 3 months prior to study entry. 4. Subjects diagnosed with any systemic autoimmune disease. 5. Contraindications or inability to undergo lumbar puncture (LP) procedure and or intrathecal administration. 6. Severe anemia (hemoglobin < 10 g/dL). 7. Abnormal renal function (serum creatinine more than 1.5xULN or creatinine clearance <30 ml/min). 8. Tested positive for HIV, hepatitis (HBV and HCV). 9. Known as positive for VDRL and/or tuberculosis. 10. Active malignant disease of any kind. However, a patient, who has had a malignant disease in the past, was treated and is currently disease - free for at least 7 years, may be considered eligible. In this case the sponsor medical expert approval is required. 11. Previous cell therapy treatment. 12. Previous total body irradiation or total lymphoid irradiation. 13. Previous use of natalizumab or any anti-B cell agent within 6 months prior to screening. 14. Previous use of immunosuppressant including Mitoxantrone, Alemtuzumab, Cladribine or any other cytotoxic agent. 15. Previous use of Fingolimod or Dimethyl Fumarate within 2 months prior to screening. Subjects who were treated with any of these medications will be excluded if they do not have a lymphocyte count of above 1,000/mm3 at screening. 16. Previous use of Teriflunomide within 12 months if no accelerated elimination procedure was used. 17. Previous treatment with immunomodulators (including IFNβ 1a and 1b, and IV Immunoglobulin (IVIG) or Glatiramer Acetate (GA) within 2 months prior to screening. 18. A known history of sensitivity to aminoglycosides and or to Vancomycin. 20. A known history of sensitivity to Gadolinium. 21. Inability to successfully undergo MRI scanning. 22. Treatment with any kind of steroids or ACTH during the last 30 days prior to screening. 23. Subjects with clotting disorders or receiving treatment with anticoagulants. 24. Any relevant medical, surgical, or psychiatric condition, laboratory value, or concomitant medication which, in the opinion of the Principle Investigator, makes the subject unsuitable for study entry or potentially unable to complete all aspects of the study. 25. Subjects with BMI < 20. 26. Pregnant or breast-feeding women. 27. Known or suspected drug or alcohol abuse. 28. Participation in any investigational drug study within 6 months prior to screening. | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：60 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | Israel | ||
| 管理信息 | 数据检测委员会 | Yes | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Stem Cell Medicine Ltd. | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | September 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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