NL-OMON46581撤回不适用
A 3-months open phase I study to assess the safety of the intrathecal application of Neuro-Cells in chronic traumatic spinal cord injury patients - Safety stem cells in spinal cord injury
europlast BV0 个研究点目标入组 10 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational non invasive
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age range 18-65 years;
- •2. Signed written informed consent;
- •3. Complete (AIS grade A) or incomplete (AIS grade B or C) traumatic spinal cord injury * 2 years before;
- •4. Sufficient number of stem cells isolated from bone marrow (> 4 million CD34+)*;
- •5. Viability of isolated stem cells >95%*.;
- •*inclusion criteria 4 and 5 are checked after bone marrow collection at Day 2, in case inclusion criteria 1 to 3 are met, and in the absence of any exclusion criteria;
排除标准
- •1.SCI AIS grade D or E at the start of the study;
- •2.Actual unstable spinal cord or other serious SCI-related (cardiac, respiratory) problems;
- •3.Trauma-induced SCI event less than 2 years ago;
- •4.Cancer, brain injury, disturbed consciousness, signs/symptoms of neurodegenerative disorder, 5.renal or cardiac insufficiency;
- •6.Any concomitant treatment or medication, that interferes with the conduct of the trial, such as immune-suppressive medication or other medication (methotrexate, cyclosporine, and corticosteroids) known to interact with the anti-inflammatory and immune-modulation actions of stem cells;
- •7.Actual abuse of alcohol, medicines or illicit drugs;
- •8.Legally protected people;
- •9. Females with childbearing potential without using adequate birth control methods, being pregnant or in the lactation period;
- •10.Participation in any clinical trial otherwise within the previous 30 days before enrolment in the trial, or simultaneous participation in such trial.;
- •11.Patients who are unable to comply with the rules of this clinical study;
研究者
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