JPRN-jRCTb030190220招募中2 期
G-CSF mobilized autologous CD34+ cell transplantation as regenerative medicine for patients with spinal cord injuries.
WATANABE Tsuyoshi0 个研究点目标入组 6 人开始时间: 2020年2月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 6
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
- >= 15age old 至 < 70age old（—）
- 性别
- All
入选标准
- •1) Cervical and thoracic spinal cord injury patients with ASIA impairment score A and B
- •2) Within 4 to 16 weeks after injury
- •3) Incomplete spinal cord injury detectable with MRI
- •4) Enable to obtain the written consent from the patient, or the guardian or the proxy
排除标准
- •1) Transection of the spinal cord with the MRI
- •2) Spinal shock
- •3) Central spinal cord injury
- •4) Organ failure of SOFA scale 3 or greater
- •5) Disturbance of consciousness (Japan Come Scale (JCS) III-200 or III-300)
- •6) Severe respiratory disorder
- •7) Hematologic disease (leukemia, myeloproliferative disorders, myelodysplastic syndromes, or sickle cell disease)
- •8) Autoimmune disorders
- •9) Liver cirrhosis
- •10) Interstitial pneumonitis or history
- •11) Malignancy or history of malignancy most recently
- •12) Positive for following viral infectious disease, HBV, HCV, HIV, ATL,Parvovirus B19.
- •13) White blood cell count, under 2,000/micro L or greater than 15,000/micro L
- •14) Platelet count, under 100,000/micro L
- •15) Hemoglobin concentration, under 10 g/dL
- •16) Aspartate aminotransferase (GOT) or alanine aminotransferase (GPT), three times greater than normal value
- •17) Serum albumin, under 2 g/dL
- •18) Splenomegaly 15 cm or larger in its longest diameter on computed tomography
- •19) Allergic reaction or adverse reaction to G-CSF or apheresis
- •20) Allergic reaction or adverse reaction to the mouse-derived protein or the other reagents
- •21) Severe multiple injury or multiple organ failure
- •22) Hemophilia
- •23) Uncontrolled ischemic heart disease including receiving a cardiovascular surgery or percutaneous coronary intervention within 12 months; severe spinal and peripheral nerve disease; tetraplegia due to brain disorder (symptomatic cerebral infarction, etc.); renal dysfunction (hemodialysis, etc.); severe psychiatric disorders
- •24) Pregnancy
- •25) Participating in other clinical studies or within 6 months after completion
- •26) Ineligible patients on this clinical study based on other clinical evidence
研究者
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