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临床试验/JPRN-UMIN000015741
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

发起方
Department of plastic surgery, Kitano hospital

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