JPRN-UMIN000015741尚未招募2 期
Phase 2 study of treatment for spinal cord injury(ASIA impairment scale A,B) with autologous mononuclear cells derived from bone marrow
Department of plastic surgery, Kitano hospital0 个研究点目标入组 20 人开始时间: 2014年11月23日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
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
- 20years-old 至 60years-old(—)
- 性别
- All
入选标准
- •1.Patients with spinal cord injuries classified as A or B on the ASIA impairment scale
- •2.Patients within 3 weeks after injury
- •3.Patients with partial spinal cord injury demonstrated by diagnostic imaging
- •4.Patients aged between 20 and 60 years at the acquisition of informed consent
- •5.Patients who submitted written informed consent by themselves
排除标准
- •1.Patients with a completely transected spinal cord
- •2.Patient with spinal shock
- •3.Patients with central spinal cord injury
- •4.Patients with organ failure with a SOFA score of 3 points or higher
- •5.Patients in whom hepatitis B, hepatitis C, human immunodeficiency virus infection, adult T-cell leukemia, or parvovirus B19 infection could not be ruled out
- •6.Patients with malignant tumor or a history of malignant tumor within 5 years
- •7.Patients with one of the following diseases/disorders:
- •?Myeloproliferative disorder or
- •myelodysplastic syndrome
- •?Autoimmune disease
- •?Spinal stenosis
- •?Limb paralysis due to central nervous
- •system disorder not attributed to spinal
- •cord injury
- •?Poorly controlled psychiatric disorder
- •8.Patients who were participating in other clinical trials or who completed participation within 6 months
- •9.Patients who were pregnant or possibly pregnant
- •10.Other patients who were judged to be ineligible by the investigators
研究者
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